Tuesday, February 24, 2015

Qualified Victory against Crony Capitalist Nutrition in North Carolina

Nutritionist female Doctor in her office. Focus on fruitGood news in the fight against monopolies in nutritional therapy.


You may remember the story of North Carolina Paleo-blogger Steve Cooksey. In 2012, Cooksey got a cease-and-desist letter from North Carolina’s Board of Nutrition/Dietetics because he was offering nutritional advice about the Paleo diet at no charge on his blog—but without a board-issued license. A legal battle ensued after the Institute for Justice took up Cooksey’s case, culminating last week in a settlement that affirmed Cooksey’s First Amendment right to post general nutrition advice on his blog.


In guidelines that were voted on and approved as part of the settlement of the case, the board stated it will not “restrict the expression of general information, guidance, or encouragement about food, lifestyle, or dietary practices.” It will, however, continue to restrict activities that occur in the context of a “professional–client relationship,” where an individual’s nutritional needs are assessed and a nutritional regime is recommended based on the perceived needs of that individual.


In essence, this means that bloggers and nutrition coaches giving general advice no longer need to fear legal action from the board. This creates a precedent for challenges to other state dietetics boards across the country. It’s no small feat, and we at ANH-USA applaud the great work done by the Institute for Justice to protect health freedom and contain crony capitalism in North Carolina.


The fight is far from over, however. While it’s good that the NC board is taking its foot off the gas in its aggression against some practitioners, the board is still free to take legal action against credentialed nutrition experts whose only “crime” is that they haven’t jumped through the board’s hoops, which are tailored for dietitians. It’s still illegal for someone with a PhD in Nutrition, for instance, to advise a client regarding his or her specific needs without first going through the board’s registration process. The only way to really fix this is to repeal or amend the law that is already on the books.


The main culprit behind the establishment of these state nutrition and dietetics boards is, of course, the Academy of Nutrition and Dietetics (AND), and they’ve been at this for quite a while. As we’ve argued before, the AND—the trade association for Registered Dietitians (RDs)—has made it a priority to pass, in as many states as possible, “scope-of-practice” laws whereby only RDs can offer nutrition services. This, of course, explicitly excludes other nutrition professionals who are often better educated, more experienced, and better qualified than RDs.


Once scope-of-practice laws pass the state legislature and are signed into law, state boards are created to enforce the RD monopoly. These state boards, which are mostly composed of RDs, have sometimes gone to great lengths to catch and punish unlicensed nutritionists through surveillance (including undercover sting operations), aggressive investigations, and prosecutions of nutrition professionals.


If this sounds a little too much like a gangster movie to you, you’re not alone.


An earlier ANH-USA investigation into the records of four state dietetics boards did not reveal a single case of an unlicensed nutrition practitioner causing harm, nor any customer-filed complaints against a nutritionist. It would seem that the draconian enforcement of AND-sponsored laws is intended only to deliver a monopoly, not a safe and healthy public.


To be fair, it’s perfectly legitimate for RDs to want to protect the term “Registered Dietitian” as a means of informing consumers of their particular professional training. At the same time, we believe in a competitive and open market for nutrition professionals, with consumers and employers (including hospitals) being able to decide what credentials, education, and experience they want in a nutrition provider.


There are currently twenty-one states with scope-of-practice laws and seventeen states with other forms of restrictive practice laws. The good news is, there’s been progress. With the help of our members and allied groups, we’ve been able to stem the tide of these bad laws in Michigan and Illinois (we’re particularly pleased about Illinois because it’s the state where AND headquarters is located!). With this recent settlement, we can add North Carolina to the list—even if it’s with an asterisk.


We will continue to monitor the issue closely and work to prevent more legal attacks against people like Steve Cooksey and other nutrition professionals.


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Too Much Dietary Cholesterol NOT a Problem After All, Says Government

Nutrition factsA federal panel has reversed itself on forty years of dietary guidelines. As usual, natural health physicians were way ahead of this news.


A federal panel, the Dietary Guidelines Advisory Committee, run jointly by the Department of Health and Human Services (HHS) and the USDA), recently released its Scientific Report of the 2015 Dietary Guidelines Advisory Committee withdrawing longstanding guidelines about avoiding high cholesterol foods. For the past forty years the government has warned about consuming food containing too much cholesterol, and as recently as five years ago deemed “excess dietary cholesterol” a problem. Now they’re saying, in effect, “Oops. It’s not a problem after all.”


ANH-USA, following the advice of our natural health experts, has been saying this for ages. In fact, in 2012 we, with several other organizations, submitted formal comment to the FDA on food and supplement facts labeling in which we strongly disagreed with the FDA’s contention that the cholesterol content of food is linked to its effect on blood cholesterol levels, given the contradictory scientific evidence available since the 1950s. We noted that “a detailed meta-analysis in 1992 found that even at moderate dietary cholesterol intakes, little change to serum cholesterol would be expected.”


Cholesterol is the basic building block of all hormones, and most of it is made by our body rather than derived from the food we eat. We’ve also noted that cholesterol isn’t the ticking time bomb most people have been led to think. Dr. Harlan Krumholz of Yale’s Department of Cardiovascular Medicine found that old people with low cholesterol died twice as often from a heart attack as did old people with high cholesterol. A review of nineteen large studies of more than 68,000 deaths by the Division of Epidemiology at the University of Minnesota found that low cholesterol predicted an increased risk of dying from gastrointestinal and respiratory diseases.


The committee states that “cholesterol is [no longer] considered a nutrient of concern for overconsumption.” Unfortunately, they do not reverse their warning against high levels of “bad” cholesterol in one’s blood, because otherwise there would be no justification for the government’s promotion of profit-making cholesterol-lowering statin drugs—even though studies demonstrate that the “LDL cholesterol is bad, HDL cholesterol is good” dichotomy is a gross oversimplification. LDL (“bad” cholesterol) is needed by the body and provides health benefits, such as protecting us from cancer. Low levels don’t even seem to lessen the risk of heart disease.


The committee’s report will be filed with Department of Agriculture and will likely be made the basis of future dietary guidelines—which affects everything from the menus for school lunches to the advertising practices of food manufacturers.


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Qualified Victory against Crony Capitalist Nutrition in North Carolina

Nutritionist female Doctor in her office. Focus on fruitGood news in the fight against monopolies in nutritional therapy. You may remember the story of North Carolina Paleo-blogger Steve Cooksey. In 2012, Cooksey got a cease-and-desist letter from North Carolina’s Board of Nutrition/Dietetics because he was offering nutritional advice about the Paleo diet at no charge on his blog—but without a board-issued license. A legal battle ensued after the Institute for Justice took up Cooksey’s case, culminating last week in a settlement that affirmed Cooksey’s First Amendment right to post general nutrition advice on his blog. In guidelines that were voted on and approved as part of the settlement of the case, the board stated it will not “restrict the expression of general information, guidance, or encouragement about food, lifestyle, or dietary practices.” It will, however, continue to restrict activities that occur in the context of a “professional–client relationship,” where an individual’s nutritional needs are assessed and a nutritional regime is recommended based on the perceived needs of that individual. In essence, this means that bloggers and nutrition coaches giving general advice no longer need to fear legal action from the board. This creates a precedent for challenges to other state dietetics boards across the country. It’s no small feat, and we at ANH-USA applaud the great work done by the Institute for Justice to protect health freedom and contain crony capitalism in North Carolina. The fight is far from over, however. While it’s good that the NC board is taking its foot off the gas in its aggression against some practitioners, the board is still free to take legal action against credentialed nutrition experts whose only “crime” is that they haven’t jumped through the board’s hoops, which are tailored for dietitians. It’s still illegal for someone with a PhD in Nutrition, for instance, to advise a client regarding his or her specific needs without first going through the board’s registration process. The only way to really fix this is to repeal or amend the law that is already on the books. The main culprit behind the establishment of these state nutrition and dietetics boards is, of course, the Academy of Nutrition and Dietetics (AND), and they’ve been at this for quite a while. As we’ve argued before, the AND—the trade association for Registered Dietitians (RDs)—has made it a priority to pass, in as many states as possible, “scope-of-practice” laws whereby only RDs can offer nutrition services. This, of course, explicitly excludes other nutrition professionals who are often better educated, more experienced, and better qualified than RDs. Once scope-of-practice laws pass the state legislature and are signed into law, state boards are created to enforce the RD monopoly. These state boards, which are mostly composed of RDs, have sometimes gone to great lengths to catch and punish unlicensed nutritionists through surveillance (including undercover sting operations), aggressive investigations, and prosecutions of nutrition professionals. If this sounds a little too much like a gangster movie to you, you’re not alone. An earlier ANH-USA investigation into the records of four state dietetics boards did not reveal a single case of an unlicensed nutrition practitioner causing harm, nor any customer-filed complaints against a nutritionist. It would seem that the draconian enforcement of AND-sponsored laws is intended only to deliver a monopoly, not a safe and healthy public. To be fair, it’s perfectly legitimate for RDs to want to protect the term “Registered Dietitian” as a means of informing consumers of their particular professional training. At the same time, we believe in a competitive and open market for nutrition professionals, with consumers and employers (including hospitals) being able to decide what credentials, education, and experience they want in a nutrition provider. There are currently twenty-one states with scope-of-practice laws and seventeen states with other forms of restrictive practice laws. The good news is, there’s been progress. With the help of our members and allied groups, we’ve been able to stem the tide of these bad laws in Michigan and Illinois (we’re particularly pleased about Illinois because it’s the state where AND headquarters is located!). With this recent settlement, we can add North Carolina to the list—even if it’s with an asterisk. We will continue to monitor the issue closely and work to prevent more legal attacks against people like Steve Cooksey and other nutrition professionals.



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Too Much Dietary Cholesterol NOT a Problem After All, Says Government

Nutrition factsA federal panel has reversed itself on forty years of dietary guidelines. As usual, natural health physicians were way ahead of this news. A federal panel, the Dietary Guidelines Advisory Committee, run jointly by the Department of Health and Human Services (HHS) and the USDA), recently released its Scientific Report of the 2015 Dietary Guidelines Advisory Committee withdrawing longstanding guidelines about avoiding high cholesterol foods. For the past forty years the government has warned about consuming food containing too much cholesterol, and as recently as five years ago deemed “excess dietary cholesterol” a problem. Now they’re saying, in effect, “Oops. It’s not a problem after all.” ANH-USA, following the advice of our natural health experts, has been saying this for ages. In fact, in 2012 we, with several other organizations, submitted formal comment to the FDA on food and supplement facts labeling in which we strongly disagreed with the FDA’s contention that the cholesterol content of food is linked to its effect on blood cholesterol levels, given the contradictory scientific evidence available since the 1950s. We noted that “a detailed meta-analysis in 1992 found that even at moderate dietary cholesterol intakes, little change to serum cholesterol would be expected.” Cholesterol is the basic building block of all hormones, and most of it is made by our body rather than derived from the food we eat. We’ve also noted that cholesterol isn’t the ticking time bomb most people have been led to think. Dr. Harlan Krumholz of Yale’s Department of Cardiovascular Medicine found that old people with low cholesterol died twice as often from a heart attack as did old people with high cholesterol. A review of nineteen large studies of more than 68,000 deaths by the Division of Epidemiology at the University of Minnesota found that low cholesterol predicted an increased risk of dying from gastrointestinal and respiratory diseases. The committee states that “cholesterol is [no longer] considered a nutrient of concern for overconsumption.” Unfortunately, they do not reverse their warning against high levels of “bad” cholesterol in one’s blood, because otherwise there would be no justification for the government’s promotion of profit-making cholesterol-lowering statin drugs—even though studies demonstrate that the “LDL cholesterol is bad, HDL cholesterol is good” dichotomy is a gross oversimplification. LDL (“bad” cholesterol) is needed by the body and provides health benefits, such as protecting us from cancer. Low levels don’t even seem to lessen the risk of heart disease. The committee’s report will be filed with Department of Agriculture and will likely be made the basis of future dietary guidelines—which affects everything from the menus for school lunches to the advertising practices of food manufacturers.



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Tuesday, February 17, 2015

2015 Survey



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2015 Survey



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State GMO Labeling Laws in Peril

Apple in two colors with a syringe. Concept for GMO.A new bill—actually a re-tread of an amendment that grassroots activists like you defeated last year—is intended to protect Big Food and Big Farma. Action Alert!


Rep. Steve King (R-IA) has reintroduced the Protect Interstate Commerce Act (PICA). He attempted to pass this legislation last year through an amendment to the Farm Bill, but ANH-USA and its allies successfully defeated the amendment. It was also roundly mocked by Stephen Colbert. Unfortunately, it still has powerful legs and could move.


Rep. King’s bill would prevent state and local government from interfering in the production and distribution of agricultural products via interstate and international commerce. In a statement, King justified the legislation by claiming that freeing chickens from cramped cages smaller than a standard sheet of paper was raising the cost of eggs too much!


One of the biggest problems with the bill is that it would undermine hard-won state GMO labeling bills. In particular, it would allow states that do not have labeling laws to freely sell their unlabeled products in states that do havelabeling laws.


The bill is bad in other many ways as well:



  • Besides effectively nullifying California’s ban on extreme confinement cages for laying hens, it would also nullify state laws in Arizona, Colorado, Florida, Maine, Michigan, Ohio, Oregon, Washington, and Rhode Island dealing with intensive confinement of farm animals.

  • It could undo laws on horse slaughter and horse meat in California, Florida, Illinois, Mississippi, New Jersey, Tennessee, and Texas (and a ban in New Jersey currently awaiting signature into law); bans on the sale of foie gras produced by force-feeding; bans on commerce in shark fins in Delaware, Maryland, Hawaii, Washington, Oregon, California, Illinois, Guam, and the Northern Mariana Islands; and potentially even bans on the sale of dog and cat meat to humans.

  • It would override the authority of states to protect the health and welfare of their citizens, such as Vermont’s ban on BPA in baby food jars and infant food containers, and Maryland’s ban on arsenic in poultry feed. It could nullify state pollution standards, such as those involving use of human sewage on crops.

  • It could affect various laws concerning agricultural employment, including even child labor laws.


Action Alert! Send a message to Congress and urge your legislators to reject the Protect Interstate Commerce Act and fight for its defeat. Please take action immediately!


Take-Action1


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State GMO Labeling Laws in Peril

Apple in two colors with a syringe. Concept for GMO.A new bill—actually a re-tread of an amendment that grassroots activists like you defeated last year—is intended to protect Big Food and Big Farma. Action Alert! Rep. Steve King (R-IA) has reintroduced the Protect Interstate Commerce Act (PICA). He attempted to pass this legislation last year through an amendment to the Farm Bill, but ANH-USA and its allies successfully defeated the amendment. It was also roundly mocked by Stephen Colbert. Unfortunately, it still has powerful legs and could move. Rep. King’s bill would prevent state and local government from interfering in the production and distribution of agricultural products via interstate and international commerce. In a statement, King justified the legislation by claiming that freeing chickens from cramped cages smaller than a standard sheet of paper was raising the cost of eggs too much! One of the biggest problems with the bill is that it would undermine hard-won state GMO labeling bills. In particular, it would allow states that do not have labeling laws to freely sell their unlabeled products in states that do havelabeling laws. The bill is bad in other many ways as well:

  • Besides effectively nullifying California’s ban on extreme confinement cages for laying hens, it would also nullify state laws in Arizona, Colorado, Florida, Maine, Michigan, Ohio, Oregon, Washington, and Rhode Island dealing with intensive confinement of farm animals.

  • It could undo laws on horse slaughter and horse meat in California, Florida, Illinois, Mississippi, New Jersey, Tennessee, and Texas (and a ban in New Jersey currently awaiting signature into law); bans on the sale of foie gras produced by force-feeding; bans on commerce in shark fins in Delaware, Maryland, Hawaii, Washington, Oregon, California, Illinois, Guam, and the Northern Mariana Islands; and potentially even bans on the sale of dog and cat meat to humans.

  • It would override the authority of states to protect the health and welfare of their citizens, such as Vermont’s ban on BPA in baby food jars and infant food containers, and Maryland’s ban on arsenic in poultry feed. It could nullify state pollution standards, such as those involving use of human sewage on crops.

  • It could affect various laws concerning agricultural employment, including even child labor laws.


Action Alert! Send a message to Congress and urge your legislators to reject the Protect Interstate Commerce Act and fight for its defeat. Please take action immediately!

Take-Action1






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Tell Us What You Think!

Computer key showing the word Feedback.What do you like about ANH-USA and The Pulse of Natural Health? What do you want to see more of? Less of?


To improve ANH-USA’s effectiveness as an advocacy group, we’d like to find out more about our most important asset—you! So we’ve created a brief readers’ survey to help us build a better organization and give you an opportunity to share your thoughts. Your input is very, very important to us.


Best of all, the survey will only take a minute or two to complete. Please click here and take our survey now!


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Tell Us What You Think!

Computer key showing the word Feedback.What do you like about ANH-USA and The Pulse of Natural Health? What do you want to see more of? Less of? To improve ANH-USA’s effectiveness as an advocacy group, we’d like to find out more about our most important asset—you! So we’ve created a brief readers’ survey to help us build a better organization and give you an opportunity to share your thoughts. Your input is very, very important to us. Best of all, the survey will only take a minute or two to complete. Please click here and take our survey now!



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Tuesday, February 10, 2015

Auto Draft







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New York AG’s Supplement Test Completely Contradicted by New Research

Herbal capsulesThe supplement ban was issued based on a single unverified test, performed by a scientist who usually studies lizards, using completely inappropriate technology—and new tests show that the original testing was wrong. State-based Action Alert!


The NY attorney general’s cease-and-desist letters to four national-chain retailers, charging them with selling nutritional supplements that were “deliberately mislabeled” and “potentially dangerous to public health,” has created a firestorm of media attention—all of which is completely unwarranted. Now one of the retailers, GNC, has proof from new tests that the products contain precisely what the labels claim.


AG Eric Schneiderman said that the products did not contain the herbal compounds that were advertised on their labels. However, he took these actions on the basis of only one testing technology from only one laboratory, performed by a scientist whose work centers on the evolutionary genetics of reptiles. The test he used, DNA barcoding, is a technology that is quite appropriate for determining the DNA of lizards and snakes, but is utterly inappropriate for testing supplements. In many commercial extraction processes for herbs, little or no DNA is extracted—so the test will assume, falsely, that the herbal compound is missing because its DNA isn’t present.


DNA barcoding has been shown to be inaccurate by botanical scientists and is not the standard utilized by the FDA in determining if products are appropriately labeled. Even scientists who are generally critical of nutritional supplements, such as Dr. Pieter Cohen of Harvard Medical School, agree that the wrong test was used.


A number of other factors make this type of testing problematic as well:



  • an incomplete library of DNA sequences was used for comparison;

  • fillers such as rice powder can produce mixed signals during the DNA sequencing process; and

  • herbal products contain plant metabolites that may prevent accurate analysis.


Appropriate analysis can be done using mass spectrometry, chromatography, and simple titration, but the AG chose to utilize an inappropriate analytical tool operated by a scientist who doesn’t have the requisite expertise to make correct determinations. At a minimum, additional testing using microscopic analysis and time-honored chemical methods should have been conducted to confirm the initial results.


GNC Holdings responded to the AG’s actions with the results of new testing that was performed on the same product lots cited in the AG’s letter. GNC used generally accepted testing methodologies approved by standard-setting bodies, including the US Pharmacopeia (USP), the Association of Agricultural Chemists (AOAC), British Pharmacopeia (BP) and European Pharmacopeia (EP). Robert Fish, an expert on FDA good manufacturing, reviewed the test results and stated, “The products at issue were each manufactured in compliance with federal FDA requirements, that the products contain the ingredients stated on the labels at the levels indicated on the labels, that the products are not contaminated, and that the products are therefore not adulterated.”


The great tragedy here is that most of the news reports about this incident seem to paint all nutritional supplements in a negative light, when the vast majority of manufacturers subject their herbal products to rigorous and open scientific testing. On top of that, they are held to current Good Manufacturing Practices (cGMP) guidelines, which require regular testing using accepted and scientifically validated methodologies. In fact, such a testing regimen, already in use throughout the industry, is one reason supplements have such an exemplary track record of safety and efficacy.


We find the timing of the AG’s rash actions to be suspect. The state of New York has been historically biased against supplements, which makes the supplement industry an easy “bogeyman” for the AG. In this case, not only did he release news of the study with no validation, and with no peer review of the findings or the testing process, he did so less than a month after New York state senator Kenneth LaValle introduced legislation that would require supplement bottles to disclose whether or not the FDA has tested them—a ridiculous requirement given the FDA doesn’t test any products of any kind, including supplements. LaValle has introduced a series of bills to establish a parallel, state regulatory regime for supplements—even though supplements are already regulated on the federal level quite thoroughly by both the FDA and the FTC.


For the past ten years, a number of different bills have been introduced in New York to regulate supplements—from multiple senators, including Sen. LaValle, who was quoted in the AG’s press release pushing his legislation. ANH-USA has consistently opposed these bills in the past.


On top of that, the AG’s actions are being used—and perhaps this was the intention all along—as a springboard to further the anti-supplement agenda being pushed by Sen. Dick Durbin (D-IL) and Sen. Richard Blumenthal (D-CT). In fact, the senators used the AG’s action as an opportunity to call on FDA to take similar steps nationwide.


But back to the New York attorney general. If he were interested in an open and honest investigation into the safety and effectiveness of nutritional supplements, why is he refusing to publish the study’s analysis for peer review? Many in the industry are frustrated at the lack of transparency over both the data and the process. The Council for Responsible Nutrition stated, “We need to call out the attorney general to give us the test data and justify why they used DNA barcoding when it’s not a validated method for finished products. We need to put the AG under the same scrutiny as he as put the industry.”


Action Alert for New York residents! Write to your state senator and representative (with a copy to the NY attorney general) and ask them to reject Sen. LaValle’s bill to create a state dietary supplement safety committee—to create a parallel regulatory structure for supplements, competing with federal law and confusing the public. Also demand that the AG’s full test report, including the product labels and reference materials used, be made available for peer review immediately. Please take action immediately!


Take-Action1


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New Food Safety Bill Needs Amending!

GMOThis is a bill sponsored in the House by Rep. DeLauro and in the Senate by Sen. Durbin. Durbin is the arch-nemesis of natural health. But with the right amendments, this bill could actually help! Action Alert! Sen. Dick Durbin (D-IL) and Rep. Rosa L. DeLauro (D-CT) have introduced a bill, the Safe Food Act of 2015, that would create a new food safety agency. Responsibility for food safety is currently split among several different agencies. This bill would consolidate that responsibility under one agency, and would among other things oversee FDA’s Food Safety Modernization Act rules. According to a DeLauro staffer, the current bill would include authority over supplements, though the specific legislative language is still not clear about that. While we appreciate DeLauro’s staffer clarifying that supplements are meant to go with food to the new agency, without explicit language we can’t guarantee those on the administrative side of implementation will agree or comply with congressional intent. ANH-USA has long advocated for an independent agency to regulate supplements, separate from both food and drugs. However, moving supplements into this new food safety agency would be a much better option than keeping them under the FDA’s jurisdiction. At the FDA they are seen as competition for drugs, and it is drugs that pay the FDA’s bills. In other words, FDA supervision of supplements involves a massive conflict of interest. We could support this bill if it includes supplements, and there are other changes. But we have to remain very wary about what else Durbin might be trying to accomplish with this bill. If what he does is consistent with his previous legislative efforts, it will have the intended effect of removing supplements from the shelves or making them too expensive for anyone but the rich to buy. On the positive side, this bill aims to protect the public from contaminants in food, including “biological, chemical, physical, radiological, and natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food or color additives.” If implemented correctly, the bill would get us closer to a real food safety bill, especially if it targets the real bad actors in the agriculture industry. The bill also provides much-needed protections for whistleblowers; perhaps our allies on the Hill will be able to introduce an amendment that includes protections against “ag-gag” laws. On the negative side, “food production establishments” are currently defined far too broadly, and include “any farm, ranch, orchard, vineyard, aquaculture facility or confined animal-feeding operation.” To put CAFOs in the same class as small organic family farms is unconscionable—they aren’t even in the same league, either economically or by scale of violation. Creating exemptions for small farms and businesses was one of our big achievements during the passage of the Food Safety Modernization Act and these exemptions must be carried over. We understand that the new agency will not have jurisdiction over the National Organic Program, which would stay under the USDA. And while we and others view GMOS as a food safety issue, the new bill does not. GMOs are currently handled by a number of agencies amid vague and confusing regulatory provisions. There really ought to be a proper regulatory structure to assess GMO safety, and this new agency would have been the logical place. The Obama administration’s 2016 budget called for the creation of this single food safety agency. Other reactions were mixed: USDA Secretary Tom Vilsack backed the plan. Some Republicans opposed the plan, including Sen. Pat Roberts (R-KS), chair of the Senate Agriculture Committee, citing increased bureaucracy, and the chief of staff for Rep. Robert Aderholt (R-AL), who heads the House Appropriations Committee, dismissed the proposal as “unserious.” Perhaps we can surprise everyone by turning this bill into something not only serious, but also useful. Action Alert! Write to your senators and representative and ask them to ask Sen. Durbin and Rep. DeLauro to amend this bill. Ask for language that explicitly makes supplement safety the responsibility of the new agency, places organics and GMOs under this new agency’s purview, adds protections against “ag-gag” laws to the whistleblower provisions, retains exemptions for small farmers, and handles CAFOs and other industrial agriculture operations separately from small farms and businesses. Let Congress know how important supplements are to you. Please send your message to Congress today!

Take-Action1






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New York AG’s Supplement Test Completely Contradicted by New Research

Herbal capsulesThe supplement ban was issued based on a single unverified test, performed by a scientist who usually studies lizards, using completely inappropriate technology—and new tests show that the original testing was wrong. State-based Action Alert! The NY attorney general’s cease-and-desist letters to four national-chain retailers, charging them with selling nutritional supplements that were “deliberately mislabeled” and “potentially dangerous to public health,” has created a firestorm of media attention—all of which is completely unwarranted. Now one of the retailers, GNC, has proof from new tests that the products contain precisely what the labels claim. AG Eric Schneiderman said that the products did not contain the herbal compounds that were advertised on their labels. However, he took these actions on the basis of only one testing technology from only one laboratory, performed by a scientist whose work centers on the evolutionary genetics of reptiles. The test he used, DNA barcoding, is a technology that is quite appropriate for determining the DNA of lizards and snakes, but is utterly inappropriate for testing supplements. In many commercial extraction processes for herbs, little or no DNA is extracted—so the test will assume, falsely, that the herbal compound is missing because its DNA isn’t present. DNA barcoding has been shown to be inaccurate by botanical scientists and is not the standard utilized by the FDA in determining if products are appropriately labeled. Even scientists who are generally critical of nutritional supplements, such as Dr. Pieter Cohen of Harvard Medical School, agree that the wrong test was used. A number of other factors make this type of testing problematic as well:

  • an incomplete library of DNA sequences was used for comparison;

  • fillers such as rice powder can produce mixed signals during the DNA sequencing process; and

  • herbal products contain plant metabolites that may prevent accurate analysis.


Appropriate analysis can be done using mass spectrometry, chromatography, and simple titration, but the AG chose to utilize an inappropriate analytical tool operated by a scientist who doesn’t have the requisite expertise to make correct determinations. At a minimum, additional testing using microscopic analysis and time-honored chemical methods should have been conducted to confirm the initial results. GNC Holdings responded to the AG’s actions with the results of new testing that was performed on the same product lots cited in the AG’s letter. GNC used generally accepted testing methodologies approved by standard-setting bodies, including the US Pharmacopeia (USP), the Association of Agricultural Chemists (AOAC), British Pharmacopeia (BP) and European Pharmacopeia (EP). Robert Fish, an expert on FDA good manufacturing, reviewed the test results and stated, “The products at issue were each manufactured in compliance with federal FDA requirements, that the products contain the ingredients stated on the labels at the levels indicated on the labels, that the products are not contaminated, and that the products are therefore not adulterated.” The great tragedy here is that most of the news reports about this incident seem to paint all nutritional supplements in a negative light, when the vast majority of manufacturers subject their herbal products to rigorous and open scientific testing. On top of that, they are held to current Good Manufacturing Practices (cGMP) guidelines, which require regular testing using accepted and scientifically validated methodologies. In fact, such a testing regimen, already in use throughout the industry, is one reason supplements have such an exemplary track record of safety and efficacy. We find the timing of the AG’s rash actions to be suspect. The state of New York has been historically biased against supplements, which makes the supplement industry an easy “bogeyman” for the AG. In this case, not only did he release news of the study with no validation, and with no peer review of the findings or the testing process, he did so less than a month after New York state senator Kenneth LaValle introduced legislation that would require supplement bottles to disclose whether or not the FDA has tested them—a ridiculous requirement given the FDA doesn’t test any products of any kind, including supplements. LaValle has introduced a series of bills to establish a parallel, state regulatory regime for supplements—even though supplements are already regulated on the federal level quite thoroughly by both the FDA and the FTC. For the past ten years, a number of different bills have been introduced in New York to regulate supplements—from multiple senators, including Sen. LaValle, who was quoted in the AG’s press release pushing his legislation. ANH-USA has consistently opposed these bills in the past. On top of that, the AG’s actions are being used—and perhaps this was the intention all along—as a springboard to further the anti-supplement agenda being pushed by Sen. Dick Durbin (D-IL) and Sen. Richard Blumenthal (D-CT). In fact, the senators used the AG’s action as an opportunity to call on FDA to take similar steps nationwide. But back to the New York attorney general. If he were interested in an open and honest investigation into the safety and effectiveness of nutritional supplements, why is he refusing to publish the study’s analysis for peer review? Many in the industry are frustrated at the lack of transparency over both the data and the process. The Council for Responsible Nutrition stated, “We need to call out the attorney general to give us the test data and justify why they used DNA barcoding when it’s not a validated method for finished products. We need to put the AG under the same scrutiny as he as put the industry.”

Action Alert for New York residents! Write to your state senator and representative (with a copy to the NY attorney general) and ask them to reject Sen. LaValle’s bill to create a state dietary supplement safety committee—to create a parallel regulatory structure for supplements, competing with federal law and confusing the public. Also demand that the AG’s full test report, including the product labels and reference materials used, be made available for peer review immediately. Please take action immediately! Take-Action1



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Monday, February 9, 2015

Which Supplement Companies Do the Experts Swear By?

Trusted Dietary supplementsFirst we asked our trusted natural health doctors and integrative physicians about supplement brands they recommend. We then added to the list based on our staff and board experience.


Please note that our list is not exhaustive; there are many excellent companies who pay a great deal of attention to quality and efficacy, and not all of them are represented here. However, here are some you may wish to research further to see if they are right for your family.


In the list below, a doctor’s name after a listing indicates that this is his or her own line of supplements; bullets indicate brand names under which the parent company sells its products:


Advanced Bionutritionals (Drs. Nan Fuchs, Robert Rowen, and Frank Shallenberger)


Allergy Research Group


Ayush Herbs


Beehive Botanicals


Bio-Tech Pharmacal, Inc.


Biotics Research


Bronson Laboratories


Carlson Laboratories


CHI Health Products


Copy Nature (Dr. Jonathan V. Wright)


Country Life


Craig Nutraceuticals


Designs for Health


Douglas Laboratories


Eclectic Institute


Ecological Formulas


EcoNugenics


Enzymatic Therapy


Essential Formulas:



Fungi Perfecti


Gaia Herbs


Garden of Life


Green Medicine (Dr. Jonathan V. Wright)


Herb Pharm


Invision International Health Solutions Inc.


Jarrow Formulas


LG Sciences


LifeExtension


LiveOn Labs


Living Fuel


Dr. Mercola Premium Supplements (Dr. Joseph A. Mercola)


Metagenics


Moss Nutrition


Natural Immunogenics Corporation


New Chapter


NOW Foods


Nutraceutical Corporation:



Nutramedix


Nutricology


Olympian Labs


Optimox


Optimum Health International LLC


Orthamolecular Products


Perricone MD Nutraceuticals (Dr. Nick Perricone)


Primal Force (Dr. Al Sears)


Pure Encapsulations


Purest Colloids


Ronald Hoffman, MD, CNS (Dr. Ronald Hoffman)


Dr. Sinatra (Dr. Steven Sinatra)


Standard Process


Thorne


Tropical Traditions


Dr. Whitaker (Dr. Julian Whitaker)


Dr. David Williams (Dr. David Williams)


Wakunaga of America


Your favorite brand not on the list? Please send us your recommendation.


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Which Supplement Companies Do the Experts Swear By?

Trusted Dietary supplementsFirst we asked our trusted natural health doctors and integrative physicians about supplement brands they recommend. We then added to the list based on our staff and board experience. Please note that our list is not exhaustive; there are many excellent companies who pay a great deal of attention to quality and efficacy, and not all of them are represented here. However, here are some you may wish to research further to see if they are right for your family. In the list below, a doctor’s name after a listing indicates that this is his or her own line of supplements; bullets indicate brand names under which the parent company sells its products: Advanced Bionutritionals (Drs. Nan Fuchs, Robert Rowen, and Frank Shallenberger) Allergy Research Group Ayush Herbs Beehive Botanicals Bio-Tech Pharmacal, Inc. Biotics Research Bronson Laboratories Carlson Laboratories CHI Health Products Copy Nature (Dr. Jonathan V. Wright) Country Life Craig Nutraceuticals Designs for Health Douglas Laboratories Eclectic Institute Ecological Formulas EcoNugenics Enzymatic Therapy Essential Formulas:



Fungi Perfecti Gaia Herbs Garden of Life Green Medicine (Dr. Jonathan V. Wright) Herb Pharm Invision International Health Solutions Inc. Jarrow Formulas LG Sciences LifeExtension LiveOn Labs Living Fuel Dr. Mercola Premium Supplements (Dr. Joseph A. Mercola) Metagenics Moss Nutrition Natural Immunogenics Corporation New Chapter NOW Foods Nutraceutical Corporation:

Nutramedix Nutricology Olympian Labs Optimox Optimum Health International LLC Orthamolecular Products Perricone MD Nutraceuticals (Dr. Nick Perricone) Primal Force (Dr. Al Sears) Pure Encapsulations Purest Colloids Ronald Hoffman, MD, CNS (Dr. Ronald Hoffman) Dr. Sinatra (Dr. Steven Sinatra) Standard Process Thorne Tropical Traditions Dr. Whitaker (Dr. Julian Whitaker) Dr. David Williams (Dr. David Williams) Wakunaga of America Your favorite brand not on the list? Please send us your recommendation.



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Wednesday, February 4, 2015

ANH Responds To NY Attorney General’s Supplement Sting Operation

Today ANH issued the following press release in response to the New York Attorney General’s investigation and claim that some large-retailer store-brand herbal supplements may not contain the herbal compounds they advertise: February 4, 2015 — The Alliance for Natural Health USA (ANH-USA) today advised caution over the New York Attorney General’s claim that some large-retailer store-brand herbal supplements may not contain the herbal compounds they advertise. According to Gretchen DuBeau, ANH-USA’s legal and executive director, the kind of test performed on those supplements is widely known to yield dubious and unreliable results. “The AG sent cease-and-desist orders on the basis of only one testing technology from only one laboratory, by a scientist who frankly lacks the requisite expertise. It should be obvious that the results are preliminary and require further substantiation before taking such a rash action,” DuBeau said. “More to the point, the tests used DNA barcoding, a technology that is rarely able to identify chemically complex herbal extracts, since in many commercial extraction processes, little or no DNA is extracted. At minimum, additional testing using microscopic analysis and time-honored chemical methods should have been conducted to confirm the initial results.” According to DuBeau, a number of factors make this type of testing problematic as well: an incomplete library of DNA sequences was used for comparison; fillers such as rice powder can produce mixed signals during the DNA sequencing process; and herbal products contain plant metabolites that may prevent accurate analysis. DuBeau was quick to point out that most of the news reports about this incident seem to paint all nutritional supplements in a negative light, when the vast majority of manufacturers subject their herbal products to rigorous and open scientific testing. At the same time, DuBeau said, recognizing the limitations of the particular tests used by the AG’s office is critical. “As a colleague pointed out, a dermatologist wouldn’t use a urine test to check for basal cell carcinoma. A botanist recognizes the drawbacks to using DNA barcoding exclusively to check for botanical identification. It doesn’t tell the whole story. We just don’t have enough information about the attorney general’s study. It is hypocritical for the AG to demand transparency from supplement companies, as current Good Manufacturing Practices require, while not being transparent in his own testing procedures.” DuBeau’s comments echoed statements from the Council for Responsible Nutrition, the American Herbal Products Association, and the Natural Products Association. ANH-USA recently published a list of nutritional supplement companies known for their extremely high manufacturing standards, careful testing, and nutrient potency. Many of the companies offer USDA Certified Organic source ingredients. The consumer advocacy group recommends the following ways to make sure your supplements are of the highest quality:

  • Always read the label. One way to compare ingredients in different products is by using the Dietary Supplements Labels Database, maintained by the National Library of Medicine.

  • Do your research or talk to a health professional. Some supplements interact with one another and with different medications—sometimes well, and sometimes not! Moreover, some supplements should be taken in combination with others; for example, calcium needs to be taken with vitamins D3 and K2, or the calcium may migrate to the heart or circulatory system where it does damage, rather than to the bones where it is needed. A trained health professional can offer important advice.

  • Talk to your supplement manufacturer. A reputable supplement manufacturer will always have a phone number where they can answer your questions about their ingredients, including where they come from and what safety procedures are in place.

  • Check the FDA’s supplement website. This database warns the public about tainted supplements—the “bad actors” of the industry—that contain illegal pharmaceuticals or deceptively labeled ingredients. These products may be promoted for weight loss, sexual enhancement, and bodybuilding. The FDA also offers an RSS feed so consumers can be kept up to date with late-breaking additions to the database.


# # #






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ANH Responds To NY Attorney General’s Supplement Sting Operation

Today ANH issued the following press release in response to the New York Attorney General’s investigation and claim that some large-retailer store-brand herbal supplements may not contain the herbal compounds they advertise:



February 4, 2015 — The Alliance for Natural Health USA (ANH-USA) today advised caution over the New York Attorney General’s claim that some large-retailer store-brand herbal supplements may not contain the herbal compounds they advertise. According to Gretchen DuBeau, ANH-USA’s legal and executive director, the kind of test performed on those supplements is widely known to yield dubious and unreliable results.


“The AG sent cease-and-desist orders on the basis of only one testing technology from only one laboratory, by a scientist who frankly lacks the requisite expertise. It should be obvious that the results are preliminary and require further substantiation before taking such a rash action,” DuBeau said. “More to the point, the tests used DNA barcoding, a technology that is rarely able to identify chemically complex herbal extracts, since in many commercial extraction processes, little or no DNA is extracted. At minimum, additional testing using microscopic analysis and time-honored chemical methods should have been conducted to confirm the initial results.”


According to DuBeau, a number of factors make this type of testing problematic as well: an incomplete library of DNA sequences was used for comparison; fillers such as rice powder can produce mixed signals during the DNA sequencing process; and herbal products contain plant metabolites that may prevent accurate analysis.


DuBeau was quick to point out that most of the news reports about this incident seem to paint all nutritional supplements in a negative light, when the vast majority of manufacturers subject their herbal products to rigorous and open scientific testing.


At the same time, DuBeau said, recognizing the limitations of the particular tests used by the AG’s office is critical. “As a colleague pointed out, a dermatologist wouldn’t use a urine test to check for basal cell carcinoma. A botanist recognizes the drawbacks to using DNA barcoding exclusively to check for botanical identification. It doesn’t tell the whole story. We just don’t have enough information about the attorney general’s study. It is hypocritical for the AG to demand transparency from supplement companies, as current Good Manufacturing Practices require, while not being transparent in his own testing procedures.”


DuBeau’s comments echoed statements from the Council for Responsible Nutrition, the American Herbal Products Association, and the Natural Products Association.


ANH-USA recently published a list of nutritional supplement companies known for their extremely high manufacturing standards, careful testing, and nutrient potency. Many of the companies offer USDA Certified Organic source ingredients. The consumer advocacy group recommends the following ways to make sure your supplements are of the highest quality:



  • Always read the label. One way to compare ingredients in different products is by using the Dietary Supplements Labels Database, maintained by the National Library of Medicine.

  • Do your research or talk to a health professional. Some supplements interact with one another and with different medications—sometimes well, and sometimes not! Moreover, some supplements should be taken in combination with others; for example, calcium needs to be taken with vitamins D3 and K2, or the calcium may migrate to the heart or circulatory system where it does damage, rather than to the bones where it is needed. A trained health professional can offer important advice.

  • Talk to your supplement manufacturer. A reputable supplement manufacturer will always have a phone number where they can answer your questions about their ingredients, including where they come from and what safety procedures are in place.

  • Check the FDA’s supplement website. This database warns the public about tainted supplements—the “bad actors” of the industry—that contain illegal pharmaceuticals or deceptively labeled ingredients. These products may be promoted for weight loss, sexual enhancement, and bodybuilding. The FDA also offers an RSS feed so consumers can be kept up to date with late-breaking additions to the database.


# # #


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Monday, February 2, 2015

FTC’s Two-Clinical-Trial Requirement for Fruit Juice Ruled Unconstitutional in POM Wonderful Case

Branch with ripe pomegranateThat’s the good news, but it goes downhill from there. The fight to rein in an out-of-control agency goes on.


Last August, ANH-USA filed a friend-of-the-court (amicus) brief in support of POM Wonderful. The Federal Trade Commission had barred the pomegranate juice company (and, by extension, other natural product companies) from advertising any so-called disease-related claims about their product unless it is backed by two random-controlled trials (RCTs).


RCTs are immensely expensive, and many natural products companies could never afford one RCT, let alone two, for each product for which they might wish to make a disease claim. A disease claim, under federal law, is any health claim that gets specific. For example, “better heart health” would not be a disease claim. But lowering blood pressure would be. The FTC’s order basically warned food and supplement producers never to make a specific disease claim unless they were prepared to spend what could be hundreds of millions of dollars on an unpatentable product.


The pomegranate juice company has spent many millions on health research of its own in addition to relying on academic research. It fought back, appealed the ruling, and the case was being heard in the DC Court of Appeals. On January 30, the three-judge panel returned its decision [link to opinion PDF]: the FTC’s blanket requirement of at least two RCTs as a precondition to any disease-related claim is indeed unconstitutional under the First Amendment—just as we had maintained in our brief.


The court stated that the FTC must “demonstrate a ‘reasonable fit’ between the particular means chosen and the government interest pursued….Here the commission fails adequately to justify a categorical floor of two RCTs for any and all disease claims.” The court noted that requiring two RCTs without justification would be very costly, and could ultimately deny consumers useful and truthful information about products. This would, in the words of the ruling, “subvert rather than promote the objectives of the commercial speech doctrine.”


So far so good. But then the court’s logic got very murky. Although a requirement for two random-controlled trials would be unconstitutional, one could be OK. Huh?


This is just one case. But based on this precedent, it’s likely that a future court would require at least one RCT. Depending on the quality of the clinical trial and the type of disease claims being demonstrated, the number of RCTs required may vary.


As we have long noted, RTCs don’t even fit food and supplement research perfectly. A drug molecule can be better isolated in its effects, although interactions with other drugs are inadequately studied. Foods and supplements are just part of our diet and often depend on co-factors. For example, supplemental calcium should not be taken without supplemental K2, but isolating it for an RCT would miss that. In addition, the effect of a food or supplement will depend in the first place on whether the subject is deficient in that nutrient. No one is nutritionally deficient in a drug. Random choice of participants for a food or supplement study is therefore illogical.


The court in this case stated that any commercial speech restriction must “directly advance the governmental interest” and “[must not be] more extensive than necessary to serve [that] interest.” This is an interesting choice of words. We would have thought that we should worry about the public interest, which is not necessarily the same as the government’s interest. In any event, it seems the only reason the court struck down the two-RCT requirement is because there could be less restrictive means to the same end, such as one RCT.


Our amicus brief highlighted another important issue as well. We argued that the FTC’s RCT requirement violates the notice-and-comment rulemaking process—that the FTC is essentially making new law, and must give the American public sufficient time to make formal comments. We made the same argument in our Citizen Petition to the FTC. Unfortunately, the court disagreed, in effect saying the FTC is free to create law this way where they are not specifically altering current law.


ANH-USA will continue working to rein in the FTC as it tries to make new law on its own. The appeals court’s word is not final. We’ll keep you posted.


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New “21st Century Cures” Bill Is Yet Another Gift to the Pharmaceutical Industry

United States Capitol building in Washington, DC That’s the good news, but it goes downhill from there. The fight to rein in an out-of-control agency goes on.


Last August, ANH-USA filed a friend-of-the-court (amicus) brief in support of POM Wonderful. The Federal Trade Commission had barred the pomegranate juice company (and, by extension, other natural product companies) from advertising any so-called disease-related claims about their product unless it is backed by two random-controlled trials (RCTs).


RCTs are immensely expensive, and many natural products companies could never afford one RCT, let alone two, for each product for which they might wish to make a disease claim. A disease claim, under federal law, is any health claim that gets specific. For example, “better heart health” would not be a disease claim. But lowering blood pressure would be. The FTC’s order basically warned food and supplement producers never to make a specific disease claim unless they were prepared to spend what could be hundreds of millions of dollars on an unpatentable product.


The pomegranate juice company has spent many millions on health research of its own in addition to relying on academic research. It fought back, appealed the ruling, and the case was being heard in the DC Court of Appeals. On January 30, the three-judge panel returned its decision [link to opinion PDF]: the FTC’s blanket requirement of at least two RCTs as a precondition to any disease-related claim is indeed unconstitutional under the First Amendment—just as we had maintained in our brief.


The court stated that the FTC must “demonstrate a ‘reasonable fit’ between the particular means chosen and the government interest pursued….Here the commission fails adequately to justify a categorical floor of two RCTs for any and all disease claims.” The court noted that requiring two RCTs without justification would be very costly, and could ultimately deny consumers useful and truthful information about products. This would, in the words of the ruling, “subvert rather than promote the objectives of the commercial speech doctrine.”


So far so good. But then the court’s logic got very murky. Although a requirement for two random-controlled trials would be unconstitutional, one could be OK. Huh?


This is just one case. But based on this precedent, it’s likely that a future court would require at least one RCT. Depending on the quality of the clinical trial and the type of disease claims being demonstrated, the number of RCTs required may vary.


As we have long noted, RTCs don’t even fit food and supplement research perfectly. A drug molecule can be better isolated in its effects, although interactions with other drugs are inadequately studied. Foods and supplements are just part of our diet and often depend on co-factors. For example, supplemental calcium should not be taken without supplemental K2, but isolating it for an RCT would miss that. In addition, the effect of a food or supplement will depend in the first place on whether the subject is deficient in that nutrient. No one is nutritionally deficient in a drug. Random choice of participants for a food or supplement study is therefore illogical.


The court in this case stated that any commercial speech restriction must “directly advance the governmental interest” and “[must not be] more extensive than necessary to serve [that] interest.” This is an interesting choice of words. We would have thought that we should worry about the public interest, which is not necessarily the same as the government’s interest. In any event, it seems the only reason the court struck down the two-RCT requirement is because there could be less restrictive means to the same end, such as one RCT.


Our amicus brief highlighted another important issue as well. We argued that the FTC’s RCT requirement violates the notice-and-comment rulemaking process—that the FTC is essentially making new law, and must give the American public sufficient time to make formal comments. We made the same argument in our Citizen Petition to the FTC. Unfortunately, the court disagreed, in effect saying the FTC is free to create law this way where they are not specifically altering current law.


ANH-USA will continue working to rein in the FTC as it tries to make new law on its own. The appeals court’s word is not final. We’ll keep you posted.


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FTC’s Two-Clinical-Trial Requirement for Fruit Juice Ruled Unconstitutional in POM Wonderful Case

Branch with ripe pomegranateThat’s the good news, but it goes downhill from there. The fight to rein in an out-of-control agency goes on. Last August, ANH-USA filed a friend-of-the-court (amicus) brief in support of POM Wonderful. The Federal Trade Commission had barred the pomegranate juice company (and, by extension, other natural product companies) from advertising any so-called disease-related claims about their product unless it is backed by two random-controlled trials (RCTs). RCTs are immensely expensive, and many natural products companies could never afford one RCT, let alone two, for each product for which they might wish to make a disease claim. A disease claim, under federal law, is any health claim that gets specific. For example, “better heart health” would not be a disease claim. But lowering blood pressure would be. The FTC’s order basically warned food and supplement producers never to make a specific disease claim unless they were prepared to spend what could be hundreds of millions of dollars on an unpatentable product. The pomegranate juice company has spent many millions on health research of its own in addition to relying on academic research. It fought back, appealed the ruling, and the case was being heard in the DC Court of Appeals. On January 30, the three-judge panel returned its decision [link to opinion PDF]: the FTC’s blanket requirement of at least two RCTs as a precondition to any disease-related claim is indeed unconstitutional under the First Amendment—just as we had maintained in our brief. The court stated that the FTC must “demonstrate a ‘reasonable fit’ between the particular means chosen and the government interest pursued….Here the commission fails adequately to justify a categorical floor of two RCTs for any and all disease claims.” The court noted that requiring two RCTs without justification would be very costly, and could ultimately deny consumers useful and truthful information about products. This would, in the words of the ruling, “subvert rather than promote the objectives of the commercial speech doctrine.” So far so good. But then the court’s logic got very murky. Although a requirement for two random-controlled trials would be unconstitutional, one could be OK. Huh? This is just one case. But based on this precedent, it’s likely that a future court would require at least one RCT. Depending on the quality of the clinical trial and the type of disease claims being demonstrated, the number of RCTs required may vary. As we have long noted, RTCs don’t even fit food and supplement research perfectly. A drug molecule can be better isolated in its effects, although interactions with other drugs are inadequately studied. Foods and supplements are just part of our diet and often depend on co-factors. For example, supplemental calcium should not be taken without supplemental K2, but isolating it for an RCT would miss that. In addition, the effect of a food or supplement will depend in the first place on whether the subject is deficient in that nutrient. No one is nutritionally deficient in a drug. Random choice of participants for a food or supplement study is therefore illogical. The court in this case stated that any commercial speech restriction must “directly advance the governmental interest” and “[must not be] more extensive than necessary to serve [that] interest.” This is an interesting choice of words. We would have thought that we should worry about the public interest, which is not necessarily the same as the government’s interest. In any event, it seems the only reason the court struck down the two-RCT requirement is because there could be less restrictive means to the same end, such as one RCT. Our amicus brief highlighted another important issue as well. We argued that the FTC’s RCT requirement violates the notice-and-comment rulemaking process—that the FTC is essentially making new law, and must give the American public sufficient time to make formal comments. We made the same argument in our Citizen Petition to the FTC. Unfortunately, the court disagreed, in effect saying the FTC is free to create law this way where they are not specifically altering current law. ANH-USA will continue working to rein in the FTC as it tries to make new law on its own. The appeals court’s word is not final. We’ll keep you posted.



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New “21st Century Cures” Bill Is Yet Another Gift to the Pharmaceutical Industry

United States Capitol building in Washington, DC That’s the good news, but it goes downhill from there. The fight to rein in an out-of-control agency goes on. Last August, ANH-USA filed a friend-of-the-court (amicus) brief in support of POM Wonderful. The Federal Trade Commission had barred the pomegranate juice company (and, by extension, other natural product companies) from advertising any so-called disease-related claims about their product unless it is backed by two random-controlled trials (RCTs). RCTs are immensely expensive, and many natural products companies could never afford one RCT, let alone two, for each product for which they might wish to make a disease claim. A disease claim, under federal law, is any health claim that gets specific. For example, “better heart health” would not be a disease claim. But lowering blood pressure would be. The FTC’s order basically warned food and supplement producers never to make a specific disease claim unless they were prepared to spend what could be hundreds of millions of dollars on an unpatentable product. The pomegranate juice company has spent many millions on health research of its own in addition to relying on academic research. It fought back, appealed the ruling, and the case was being heard in the DC Court of Appeals. On January 30, the three-judge panel returned its decision [link to opinion PDF]: the FTC’s blanket requirement of at least two RCTs as a precondition to any disease-related claim is indeed unconstitutional under the First Amendment—just as we had maintained in our brief. The court stated that the FTC must “demonstrate a ‘reasonable fit’ between the particular means chosen and the government interest pursued….Here the commission fails adequately to justify a categorical floor of two RCTs for any and all disease claims.” The court noted that requiring two RCTs without justification would be very costly, and could ultimately deny consumers useful and truthful information about products. This would, in the words of the ruling, “subvert rather than promote the objectives of the commercial speech doctrine.” So far so good. But then the court’s logic got very murky. Although a requirement for two random-controlled trials would be unconstitutional, one could be OK. Huh? This is just one case. But based on this precedent, it’s likely that a future court would require at least one RCT. Depending on the quality of the clinical trial and the type of disease claims being demonstrated, the number of RCTs required may vary. As we have long noted, RTCs don’t even fit food and supplement research perfectly. A drug molecule can be better isolated in its effects, although interactions with other drugs are inadequately studied. Foods and supplements are just part of our diet and often depend on co-factors. For example, supplemental calcium should not be taken without supplemental K2, but isolating it for an RCT would miss that. In addition, the effect of a food or supplement will depend in the first place on whether the subject is deficient in that nutrient. No one is nutritionally deficient in a drug. Random choice of participants for a food or supplement study is therefore illogical. The court in this case stated that any commercial speech restriction must “directly advance the governmental interest” and “[must not be] more extensive than necessary to serve [that] interest.” This is an interesting choice of words. We would have thought that we should worry about the public interest, which is not necessarily the same as the government’s interest. In any event, it seems the only reason the court struck down the two-RCT requirement is because there could be less restrictive means to the same end, such as one RCT. Our amicus brief highlighted another important issue as well. We argued that the FTC’s RCT requirement violates the notice-and-comment rulemaking process—that the FTC is essentially making new law, and must give the American public sufficient time to make formal comments. We made the same argument in our Citizen Petition to the FTC. Unfortunately, the court disagreed, in effect saying the FTC is free to create law this way where they are not specifically altering current law. ANH-USA will continue working to rein in the FTC as it tries to make new law on its own. The appeals court’s word is not final. We’ll keep you posted.



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