Press Release: Attorney General Demonstrates Fundamental Misunderstanding of What the FDA Does

Troubling video exposes AG’s lack of understanding of drug approval process and dietary supplement regulation

March 10, 2016 — As part National Consumer Protection Week, United States Attorney General Loretta Lynch released a video warning consumers about the “potential dangers” of taking nutritional supplements. She cautions that, unlike pharmaceutical drugs, the Food and Drug Administration (FDA) does not test dietary supplements, prior to their introduction into the market.

This assertion is troubling for a number of reasons. First, the FDA does not test any substance before market introduction. Drug companies are responsible for conducting tests on their own products and submitting the results of those tests as a part of a new drug application (NDA).

“The highest legal officer in the country needs to understand the process by which drugs and supplements come to the market,” explained Gretchen DuBeau, legal and executive director for the Alliance for Natural Health-USA. “Her office has rightfully prosecuted a number of bad industry actors this year, including USP Labs, but her misstatements about the regulation of these products will dissuade consumers from taking the supplements they need to stay healthy.”

Lynch also bases her pronouncement about supplements upon faulty definitions. She cites a number of cases where her office has prosecuted bad actors that illegally marketed mislabeled products, but calls these products dietary supplements.

“This is the equivalent of calling monopoly money legal currency,” observed DuBeau. “The fact that the products were deemed illegal and misbranded necessitates that they be called what they are— counterfeits.”

A comparison between the safety record of pharmaceutical drugs and dietary supplements is revealing. According to data from Harvard University, FDA-approved drugs cause 1.9 million hospitalizations, 2.74 million serious adverse reactions, and 128,000 deaths annually. Supplement adverse reactions are minuscule by comparison.

Americans take approximately 60 billion doses of dietary supplements each year. “You’re five times more likely to be killed by a lightning strike, 581 times more likely to be killed in a boating accident, and 98,000 times more likely to be killed by an FDA-approved and properly prescribed pharmaceutical drug than by a legal dietary supplement,” said DuBeau. “The bigger, more important picture is this: despite some bad apples, the supplement industry still produces the safest products that humans ingest.”

Lynch is right in cautioning consumers to research the supplements they consider taking. As with any product, nutritional supplements vary in quality. 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 and talk to a healthcare 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 always 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.

The Alliance for Natural Health USA has created a website specifically designed to address questions related to supplement safety: AreMySupplementsSafe.com.

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