Are Draconian Limits on Vitamins Coming to the US?

Meetings being held between the National Academy of Sciences (NAS) and other world bodies to discuss “harmonization” (meaning restriction) of “nutrient intake” recommendations indicate that the answer may be yes.  Action Alert!

NAS, which is a United States non-governmental organization that advises the federal government on a range of issues, recently met with groups from the World Health Organization and the United Nations, both of which are sponsors of Codex,  a long time threat to US supplements,  to discuss possible supplement restrictions under the guise of facilitating trade.

Severe restrictions on vitamin doses in supplements are already well under way in the European Union, and it doesn’t look good. At one point, the European Food Safety Authority (EFSA) discussed setting the maximum level for beta carotene in a supplement to the amount provided by half a carrot, and the maximum level of selenium to what is found in one-third of a brazil nut.

EFSA could arrive at such nonsensical conclusions only through bad science, as our scientific director Rob Ververk has demonstrated. The methods they used originated from concerns about environmental toxins, which of course have no beneficial role in health. Nutrients are quite distinct, and as such, require a completely different approach. For example, their analysis failed to break down a nutrient group; instead EFSA set a maximum level based on the most hazardous (and usually synthetic) member of a given nutrient group such as vitamin A (retinol /natural b-carotene), or iron (iron sulphate /ferrous bisglycinate). These methods obviously yield skewed results and did not take into account variations in the population (age, race, genetics, etc.) that affect the amount of nutrients one might need.

The dose limiting in Europe, while bad for Europeans seeking to optimize health through therapeutic levels of nutrients, normally wouldn’t be an immediate cause for concern for those of us in the United States. This is where Codex Alimentarius comes in. Codex was initially developed as an intergovernmental body to establish international food safety standards and regulate ingredients of food products with the stated goal of promoting “fair trade practices” and consumer protections in the global trade for food. A country does not have to adopt Codex standards, but approximately 300 Codex guidelines and standards are used by its member countries as the basis for their regional and national laws.

Codex standards regarding supplements are widely expected to follow EFSA and the EU’s lead, since the EU has considerable influence in Codex. A few years ago, there was great concern that the US, a member of Codex, would adopt these restrictive standards behind closed doors without public involvement. If the FDA follows the law, however, this shouldn’t be the case. Adopting international standards should be a public process, either through a comment-rulemaking procedure or through the creation of legislation in Congress. Either way, the public should have an opportunity to weigh in.

The larger question of whether the FDA can ban high-dose supplements without public involvement, though, is less black and white. Our concern is that the question is no longer whether the US might try to adopt Codex standards, but whether it will follow the EU’s lead and create standards, including upper limits, on its own.

Federal law defines an adulterated supplement as a supplement that “presents a significant or unreasonable risk of illness or injury” either when used according to the product’s label or under ordinary conditions of use. Recently, the FDA determined through a guidance document that certain bulk caffeine products were adulterated because they contained hundreds of potentially lethal doses. The FDA said that these products must either be diluted or sold in pre-measured packets. This is important in as much as the FDA made a determination through guidance, rather than rulemaking, about what an “adulterated” supplement is—and the FDA cannot be legally challenged for positions taken in a guidance. Might the FDA point to NAS recommended upper limits on vitamins to turn around and say that any supplements containing doses above those levels are “adulterated” because they “present a significant or unreasonable risk of illness or injury”? It’s unclear, but this concerning avenue seems open.

The involvement of the NAS appears to mark the initial phase of bringing the discussion of establishing upper limits for vitamins to the US. Codex is in large part a project of the World Health Organization and the Food and Agriculture Organization of the United Nations—two of the other groups present at the NAS’s workshop, in addition to representatives from EFSA. These are not good signs and suggest the US, too, may follow the flawed European approach to setting limits on vitamins.

It also should be mentioned that, irrespective of influence from Europe and other world bodies, the National Academies of Science, formerly known as the Institute of Medicine, has proven definitively that, when it comes to supplements, it has no idea what it’s talking about. For example, the organization’s recommended daily allowance for vitamin D is a paltry 600 IU for adults; it’s upper level—that is, the level above which the organization said poses a danger to the individual—is 4,000 IU for adults. The Vitamin D Council, on the other hand, recommends 5,000 IU of vitamin D for adults, and other estimates are even higher. Put simply, we do not want the NAS anywhere near a discussion that could lead to limits on the levels of nutrients a supplement can contain.

We cannot wait for these discussions to take a more concrete form to take action. We need to stop the NAS in their tracks now.

Action Alert! Write to Congress, the FDA, and NAS and ask them not to allow the National Academy of Sciences (NAS) to engineer severe upper limits on supplement doses along the lines set by the EU and world body Codex. Please send your message immediately.

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What do Opioids, Politicians, and Your Doctor Have in Common?

Bribery. Action Alert!

Separate reports have surfaced that demonstrate both doctors and politicians are on opioid-makers’ pay roll. In return it appears as though doctors have prescribed more opioids and lawmakers have backed legislation to make it harder to combat the opioid crisis. This is cronyism 101.

First, the doctors. Researchers have reported evidence that the doctors who receive the most attention from drug companies—such as paid speaking jobs, free lunches, and branded merchandise—prescribe the largest amount of opioid drugs. The researchers report that every free meal given to a doctor from a pharmaceutical company resulted in a spike of opioid prescriptions.

Next, Congressional candidates gearing up for midterm elections are pointing out examples of current lawmakers accepting pharmaceutical money and then supporting legislation that makes it more difficult for the federal government to regulate the opioid industry—specifically, the legislation made it more difficult for the Drug Enforcement Agency (DEA) to suspend suspicious orders of opioids. Big Pharma dumped millions into the campaigns of lawmakers at the time, and spent much more on lobbying efforts in support of the bill. It seems that it was money well spent. Sitting lawmakers of course deny that there was any quid pro quo, but the connection to us seems obvious.

These are the forces that are preventing cheap, safe, and effective natural medicine from seeing the light of day in our medical system. Big Pharma influences doctors to prescribe their expensive and dangerous medicines; they also grease the wheels in Washington to ensure that there aren’t any legislative threats to their bottom line; the FDA, which is meant to regulate the drug industry, receives its funding from them.

There are, of course, natural alternatives to pain management, such as fish oil, sulfur-containing MSM, and cannabidiol (CBD) oil, but the government is making moves to remove these alternatives from the market. An FDA advisory committee voted to ban MSM medications from being made at compounding pharmacies, and the federal government is moving in on CBD oil. It’s the same old, same old in our crony capitalist health system.

Action Alert! Send a message to the FDA and Congress, telling them to retain consumer access to affordable MSM and CBD oil supplements. Please send your message immediately.

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Finally! Some Relief for Dying Patients

Thanks to ANH member activism over many years, Congress has finally approved Right to Try legislation. Tell President Trump to sign it into law! Action Alert!

Yesterday, the House of Representatives approved legislation that expands access to experimental drugs for terminally ill patients who have exhausted all other treatment options. It also frees drug companies from liability where trial medications are provided. Patients and their families who desire access to experimental drugs are faced with incredibly difficult life- and- death decisions. Such decisions should be between a patient and his or her doctor, not with the FDA standing in the way.   As the law stands now, patients need to go through an FDA bureaucracy to get access to experimental drugs. This is an unnecessary government intrusion into a patient’s life.

This is a long-overdue win. ANH has supported this legislation for years, and in fact worked with former Representative Ron Paul of Texas on a very early, more expansive version of the bill that included the right to choose alternative natural treatments as well. We will continue to work to make a patient’s “right to try” broader, to include non-drug treatments.

Next the bill will be sent to President Trump’s desk for his approval.

The fight, of course, is not over. While this bill is an important stepping stone, patients are still blocked from choosing many alternative treatments, either through medical monopolies or government regulation. The core of ANH’s mission is to allow patients the freedom to choose the treatments that work best for them. There is much more work to be done, but it is heartening to see that common-sense legislation can be enacted.

Action Alert! Write to Congress and urge your representatives to expand the Right to Try law to non-drug treatments where they are restricted by law. Please send your message immediately.

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Update: Victory in the War on Natural Medicine!

ANH members played a key role in thwarting efforts to eliminate access to personalized medicine.

Two years ago, the FDA released a draft guidance saying that a compounding pharmacy (a pharmacy that makes customized medicines for individual patients) cannot register as both an “outsourcing” (503B) and a traditional (503A) facility. We issued an action alert to ANH members to speak out against this policy and submitted detailed legal comments drafted by our general counsel. The agency just released the final guidance, and the FDA listened to our criticisms. The bottom line is that this change will make it much easier for many compounding pharmacies to stay in business, meaning patients will be better able to get the medicines, such as nutrient IV infusions and bioidentical hormones like progesterone and estriol, that they need.

This is an important victory. The Drug Quality and Security Act of 2013 (DQSA) separated compounding pharmacies into two categories:

• “traditional” compounding pharmacies (regulated under section 503A of the Food, Drug, and Cosmetic Act), and
• “outsourcing” compounding pharmacies (regulated under section 503B of the same law).

Among the main differences between these two pharmacies are that outsourcing pharmacies can engage in office use compounding (making medicines for doctors to keep on-hand in their offices), and can ship medicines interstate without restriction, but they can only compound substances from a limited, preapproved list from the FDA. It is already clear that the FDA intends this medications list to be very short. Because outsourcing facilities can compound for office use and ship interstate, they are well-placed to capture a large portion of the market—even if they can only compound from a shorter list of medications.

Traditional pharmacies can no longer engage in office use, and can only ship between 5% and 30% of total orders out-of-state, but they are able to make many medications that outsourcing facilities cannot. Specifically, they can compound medications that have a USP monograph, are components of approved drugs, or are on a preapproved list. For example, the bioidentical hormone estriol is, as of yet, not included on a preapproved list for outsourcing facilities to compound, and we believe it unlikely to be added; however, because it has a USP monograph, traditional pharmacies can make it. (Note that special interests are attempting to ban estriol through another process, and we are fighting them every step of the way.)

Remember that the FDA is funded by drug companies, not pharmacies, and drug companies see compounded medicine as competition and a threat to their bottom line. It seems to us no surprise then that the FDA policies of limiting office use and interstate sales would first pressure traditional pharmacies to register as outsourcing facilities, where the FDA can decide what medications can be made. Second, FDA’s latest proposal would have eliminated their ability to still provide medications they can make as a 503A traditional pharmacy. They would have been forced to choose: switch to an outsourcing facility where the FDA is more in control, or remain a traditional pharmacy and potentially go out of business.

We’re glad that the FDA has changed course and will allow pharmacies the flexibility to compound as both outsourcing and traditional facilities. Unless the FDA has something else up its sleeve, this change in course will help many pharmacies keep their doors open. We must continue to hold the agency’s feet to the fire to prevent even more damage to the compounding industry!

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Action Alert: Protect High Dose Supplements

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Are Draconian Limits on Vitamins Coming to the US?

Meetings being held between the National Academy of Sciences (NAS) and other world bodies to discuss “harmonization” (meaning restriction) of “nutrient intake” recommendations indicate that the answer may be yes.  Action Alert!

NAS, which is a United States non-governmental organization that advises the federal government on a range of issues, recently met with groups from the World Health Organization and the United Nations, both of which are sponsors of Codex,  a long time threat to US supplements,  to discuss possible supplement restrictions under the guise of facilitating trade.

Severe restrictions on vitamin doses in supplements are already well under way in the European Union, and it doesn’t look good. At one point, the European Food Safety Authority (EFSA) discussed setting the maximum level for beta carotene in a supplement to the amount provided by half a carrot, and the maximum level of selenium to what is found in one-third of a brazil nut.

EFSA could arrive at such nonsensical conclusions only through bad science, as our scientific director Rob Ververk has demonstrated. The methods they used originated from concerns about environmental toxins, which of course have no beneficial role in health. Nutrients are quite distinct, and as such, require a completely different approach. For example, their analysis failed to break down a nutrient group; instead EFSA set a maximum level based on the most hazardous (and usually synthetic) member of a given nutrient group such as vitamin A (retinol /natural b-carotene), or iron (iron sulphate /ferrous bisglycinate). These methods obviously yield skewed results and did not take into account variations in the population (age, race, genetics, etc.) that affect the amount of nutrients one might need.

The dose limiting in Europe, while bad for Europeans seeking to optimize health through therapeutic levels of nutrients, normally wouldn’t be an immediate cause for concern for those of us in the United States. This is where Codex Alimentarius comes in. Codex was initially developed as an intergovernmental body to establish international food safety standards and regulate ingredients of food products with the stated goal of promoting “fair trade practices” and consumer protections in the global trade for food. A country does not have to adopt Codex standards, but approximately 300 Codex guidelines and standards are used by its member countries as the basis for their regional and national laws.

Codex standards regarding supplements are widely expected to follow EFSA and the EU’s lead, since the EU has considerable influence in Codex. A few years ago, there was great concern that the US, a member of Codex, would adopt these restrictive standards behind closed doors without public involvement. If the FDA follows the law, however, this shouldn’t be the case. Adopting international standards should be a public process, either through a comment-rulemaking procedure or through the creation of legislation in Congress. Either way, the public should have an opportunity to weigh in.

The larger question of whether the FDA can ban high-dose supplements without public involvement, though, is less black and white. Our concern is that the question is no longer whether the US might try to adopt Codex standards, but whether it will follow the EU’s lead and create standards, including upper limits, on its own.

Federal law defines an adulterated supplement as a supplement that “presents a significant or unreasonable risk of illness or injury” either when used according to the product’s label or under ordinary conditions of use. Recently, the FDA determined through a guidance document that certain bulk caffeine products were adulterated because they contained hundreds of potentially lethal doses. The FDA said that these products must either be diluted or sold in pre-measured packets. This is important in as much as the FDA made a determination through guidance, rather than rulemaking, about what an “adulterated” supplement is—and the FDA cannot be legally challenged for positions taken in a guidance. Might the FDA point to NAS recommended upper limits on vitamins to turn around and say that any supplements containing doses above those levels are “adulterated” because they “present a significant or unreasonable risk of illness or injury”? It’s unclear, but this concerning avenue seems open.

The involvement of the NAS appears to mark the initial phase of bringing the discussion of establishing upper limits for vitamins to the US. Codex is in large part a project of the World Health Organization and the Food and Agriculture Organization of the United Nations—two of the other groups present at the NAS’s workshop, in addition to representatives from EFSA. These are not good signs and suggest the US, too, may follow the flawed European approach to setting limits on vitamins.

It also should be mentioned that, irrespective of influence from Europe and other world bodies, the National Academies of Science, formerly known as the Institute of Medicine, has proven definitively that, when it comes to supplements, it has no idea what it’s talking about. For example, the organization’s recommended daily allowance for vitamin D is a paltry 600 IU for adults; it’s upper level—that is, the level above which the organization said poses a danger to the individual—is 4,000 IU for adults. The Vitamin D Council, on the other hand, recommends 5,000 IU of vitamin D for adults, and other estimates are even higher. Put simply, we do not want the NAS anywhere near a discussion that could lead to limits on the levels of nutrients a supplement can contain.

We cannot wait for these discussions to take a more concrete form to take action. We need to stop the NAS in their tracks now.

Action Alert! Write to Congress, the FDA, and NAS and ask them not to allow the National Academy of Sciences (NAS) to engineer severe upper limits on supplement doses along the lines set by the EU and world body Codex. Please send your message immediately.

from The Alliance for Natural Health https://ift.tt/2s82OiE via Aloe for Health

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What do Opioids, Politicians, and Your Doctor Have in Common?

Bribery. Action Alert!

Separate reports have surfaced that demonstrate both doctors and politicians are on opioid-makers’ pay roll. In return it appears as though doctors have prescribed more opioids and lawmakers have backed legislation to make it harder to combat the opioid crisis. This is cronyism 101.

First, the doctors. Researchers have reported evidence that the doctors who receive the most attention from drug companies—such as paid speaking jobs, free lunches, and branded merchandise—prescribe the largest amount of opioid drugs. The researchers report that every free meal given to a doctor from a pharmaceutical company resulted in a spike of opioid prescriptions.

Next, Congressional candidates gearing up for midterm elections are pointing out examples of current lawmakers accepting pharmaceutical money and then supporting legislation that makes it more difficult for the federal government to regulate the opioid industry—specifically, the legislation made it more difficult for the Drug Enforcement Agency (DEA) to suspend suspicious orders of opioids. Big Pharma dumped millions into the campaigns of lawmakers at the time, and spent much more on lobbying efforts in support of the bill. It seems that it was money well spent. Sitting lawmakers of course deny that there was any quid pro quo, but the connection to us seems obvious.

These are the forces that are preventing cheap, safe, and effective natural medicine from seeing the light of day in our medical system. Big Pharma influences doctors to prescribe their expensive and dangerous medicines; they also grease the wheels in Washington to ensure that there aren’t any legislative threats to their bottom line; the FDA, which is meant to regulate the drug industry, receives its funding from them.

There are, of course, natural alternatives to pain management, such as fish oil, sulfur-containing MSM, and cannabidiol (CBD) oil, but the government is making moves to remove these alternatives from the market. An FDA advisory committee voted to ban MSM medications from being made at compounding pharmacies, and the federal government is moving in on CBD oil. It’s the same old, same old in our crony capitalist health system.

Action Alert! Send a message to the FDA and Congress, telling them to retain consumer access to affordable MSM and CBD oil supplements. Please send your message immediately.

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