Congress, the Food and Drug Administration (FDA), and Dietary Supplements

The dietary supplement industry (vitamins, herbs) has bought off Congress to keep the FDA from regulating products that in reality are sold as drugs.

The dietary supplement industry is huge in the United States. A 2002 FDA survey concluded that 75% of Americans used dietary supplements (vitamin or herbal) within the previous year. That survey also concluded that 14.5 of Americans (a different survey said 20%) used herbal (non-vitamin/non-mineral, NVNM) supplements within the previous year. About 6% of Americans used NVNM supplements every day. The most used NVNM supplements were Echinacea, ginkgo balboa, garlic pills, ginseng and saw palmetto.

Before Congress got involved in 1994, the FDA regulated dietary supplements under The Federal Pure Food and Drugs Act (1906) and The Federal Food, Drug, and Cosmetic Act (FD&C Act) (1938). Under these laws, supplements were treated as food, and the FDA emphasized truth in labeling and safety.

In 1958, the FD&C Act New Food Additive Amendments added supplements to the items under FDA control. With these laws, all new food additives needed prior approval.

Everything changed in 1994, when Congress passed the Dietary Supplement Health and Education Act (DSHEA). The new law removed dietary supplements from food category and created a new, separate, and essentially unregulated “dietary supplement” category. The DSHEA defined dietary supplements as “a concentrate, metabolite, constituent, extract, or combination of vitamins, minerals, herbs (or other botanicals), or amino acids used to supplement the diet by increasing the total dietary intake.”

“Dietary Supplement” implies nutritional content though many have none.

The Dietary Supplement Health and Education Act of 1994 created a facade of regulation but essentially stripped the FDA of all authority in regulating the claims these products. The FDA lost its ability to insure that these products actually are what they say they are. An example of this “regulation facade” is the requirement that the supplement industry “evaluate” pill composition. However, the industry is not required to report that evaluation to the FDA. The FDA also cannot require submission of efficacy and safety information prior to the pill going on the market. New supplements do not require FDA approval. The FDA can act only after a dietary supplement has been on the market and there is a problem. The law mandated only voluntary adverse event reporting. Prescription drug companies are required to tell the FDA about any problems possibly related to their drugs, but the supplement companies were not required to do so. The law also stipulated that the supplements could not claim to “diagnose, cure, mitigate, treat, or prevent illness.” However, the supplements do just that, along with a disclaimer that says, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” Supplement labels make claims on the front of the label while showing the disclaimer less prominently on the rear of the label. Even worse, the Federal Trade Commission (which regulates all drug advertising outside of the control of the FDA) does not require the disclaimer in dietary supplement advertising.

Do you remember Ephedra? Between 1993 and 1997, over 800 Ephedra adverse event reports were made by doctors. As a result, in 1997, the FDA proposed a ban on ephedra but could not get supporting evidence. The FDA was not allowed to demand adverse event information or product samples. In 2000, the FDA finally bowed to Congressional pressure and dropped the ban proposal. In 2002, the government ordered a safety study. In 2003, some states banned Ephedra. After a 2003 high-profile pro-athlete death (a pitcher for the Baltimore Orioles), Congress finally was forced to allow the FDA to ban Ephedra in 2004.

In 2006, there was growing pressure from the public to regulate the dietary supplement industry. Therefore, Congress passed another law that was designed to give the appearance of protecting the American people but in reality was designed to help the dietary supplement industry. It was “the Dietary Supplement and Nonprescription
Drug Consumer Protection Act.” In this law, the supplement industry gave an inch and took a mile. The new law said companies must report serious adverse events (a government term loosely defined here as a health problem resulting in death or hospitalization) along with a copy of the product label. The supplement companies were also required to keep records of (but not report) all non-serious adverse events for six years. The new law also required product labels to include contact information.

All of this sounds good on the surface, but the supplement industries got a lot more than they gave up. Companies were still not required to provide any information to the FDA before selling a supplement. The adverse event reporting rules result in only about 1% of all adverse events being reported to the FDA. If there is a serious adverse event, the supplement company does not have to send a sample of the product along with the report. The law also (and this is the biggie) prohibited states from regulating supplements in any way whatsoever. The companies still did not have to prove that their products were good, but the FDA still (if it wanted to act) had to prove the supplements were bad AFTER something happened. In the first year of serious adverse event reporting, 608 serious adverse events were reported (368 required reports from supplement companies and 236 from private citizens and healthcare workers). Previously, before the reporting requirement, the supplement industry said they never received any adverse event complaints against any of their products.

Still, the FDA is doing what it can. In 2007, the FDA issued “Dietary Supplement Current Good Manufacturing Practices.” While prohibited from going any further by law, the guidance covered design and construction of physical plants, manufacturing operations, quality control procedures, testing materials, consumer complaints handling, and records maintenance. However, the FDA cannot enforce these practices, and nothing still need be submitted prior to a supplement going on the market.

Because the FDA is not allowed to require it, there is little clinical evidence that these supplements are effective or safe. Some clinical trials have been done on dietary supplements, but lack of standardization leaves results inconclusive at best and meaningless at worst. A given herb has varying potency depending on where and how it was grown (weather, altitude, soil quality, sunlight exposure, etc.) and prepared. The National Institutes of Health said, “Most of the studies we examined do not provide strong evidence for beneficial health-related effects of supplements taken singly, in pairs, or in combinations of three or more....However, several other studies also provide disturbing evidence of risk, such as increased lung cancer risk with β-carotene use among smokers.”

The problem of the FDA’s lack of authority over the supplement industry is made worse by the public’s perception that the supplement industry is subject to FDA authority. The vast majority of Americans believe that supplements are approved by the FDA and are thus effective and safe. Further, the conflicting claims and disclaimers on product labels result in people believing what they want to believe. Studies that show a lack of effectiveness do not cause a nationwide decrease in supplement use. Only well publicized incidents relating to safety result in decreased use.

For the future, the U.S. General Accounting Office recommends that supplement companies be required to 1) Register as dietary supplement companies, 2) provide all supplement names with labels and 3) report all adverse events related to dietary supplements. The General Accounting Office also recommends that the FDA “educate consumers that it does not analyze and approve dietary supplements and seek more authority over supplements sold in U.S.”

I do not expect it to happen anytime soon. Money talks.


References
Sadovsky R, Collins N, Tighe A, Brunton S, Safeer R. Patient use of dietary supplements: a clinician’s perspective. Current Medical Research and Opinion. Vol. 24, No. 4, 2008, 1209–1216

Dietary Supplement Health and Education Act of 1994, Public Law 103-417, 103rd Congress. Available at: http://www.fda.gov/opacom/laws/dshea.html [accessed March 3, 2006]

U.S. Food and Drug Administration. Dietary Supplements Overview. http://www.cfsan.fda.gov/~DMS/supplmnt.html Accessed 4/21/09

Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding. The U.S. Government Accountability Office http://www.gao.gov/products/GAO-09-250 Accessed 4/21/09

Public Law 109–462—Dec. 22, 2006 http://www.fda.gov/cder/regulatory/public_law_109462.pdf Accessed 4/21/06

AJ Perez. (2008, September 23). Dietary supplements cause 600 'adverse events' :First data since reporting law. USA TODAY,p. D.7. Retrieved April 22, 2009, from National Newspaper Abstracts (3) database. (Document ID: 1560768251).

Katherine Wong. (2007). New Mandatory Reporting Requirements for Dietary Supplements and Nonprescription Drugs Solve Very Little. The Journal of Law, Medicine & Ethics, 35(2), 336-339. Retrieved April 22, 2009, from Research Library database. (Document ID: 1334834441).

Sarah Lueck and Anna Wilde Mathews. (2003, December 30). FDA Is Expected to Ban Ephedra, Citing Supplement's Health Risks. Wall Street Journal (Eastern Edition), p. A.1. Retrieved April 22, 2009, from ABI/INFORM Complete database. (Document ID: 517744241).

Metabolife Praises FDA Withdraw of Proposed Ephedra Restrictions. (3 April). PR Newswire,1. Retrieved April 22, 2009, from ABI/INFORM Complete database. (Document ID: 52164278).
References

Timbo BB, Ross MP, McCarthy PV, Lin CT. Dietary supplements in a national survey: prevalence of use and reports of adverse events. J Am Diet Assoc 2006;106:1966-74

Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts. U.S. Food and Drug Administration. http://www.foodsafety.gov/~dms/dscgmps6.html Accessed 4/22/09

Report: FDA lacks authority over supplements – Without necessary resources, 'it's like the Wild West' USA TODAY (Arlington, VA) - Wednesday, March 4, 2009 Author: Elizabeth Weise: (c) USA TODAY

Bent S. Herbal Medicine in the United States: Review of Efficacy, Safety,
and Regulation J Gen Intern Med 23(6):854–9. 2008

Foote, J. Protecting Consumers in the Wake of the U.S. Dietary Supplement Health and Education Act. Journal of Allied Health , Spring 2007

Bent S, Ko R. Commonly Used Herbal Medicines in the United States: A Review
Am J Med. 2004 ;116:478–485.

NIH State-of-the-Science Conference Statement on Multivitamin/Mineral Supplements
and Chronic Disease Prevention. The National Institutes of Health. NIH Consensus and State-of-the-Science Statements Volume 23, Number 2. 2006

Tilburt J, Emanuel E. Does the Evidence Make a Difference in Consumer Behavior? Sales of Supplements Before and After Publication of Negative Research Results. J Gen Intern Med 23(9):1495–8 2008.