FDA Oversight of Dietary Supplements

For additional information, please also view: The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled

Introduction

One of the largest points of misinformation available regarding natural medicine is the claim that dietary supplements are not regulated by the FDA. This is a patently false claim. In actuality, oversight of dietary supplements is charged to the Principal Deputy Commissioner at the Food and Drug Administration (FDA), an agency of the Department of Health and Human Services (HHS). This charge is conferred through the Dietary Supplement Health and Education Act (Sen. Orrin Hatch, R-UT) (DSHEA).

The regulation of dietary supplements is largely a hybrid between food and drugs. As can be expected, there are some people who feel that dietary supplements should be regulated more as drugs than as foods. There are also those who feel that dietary supplements should be regulated less as drugs and more as foods.

There are three principles which guide the regulation of dietary supplements: protection from harm, quality of manufacturing, and integrity of marketing.

Protection From Harm

The public feels that it should be reasonably assured that consumption of dietary supplements will not cause significant harm. Dietary supplements may interact with certain medications, and can be harmful when taken in excess. Despite these risks, dietary supplements have been demonstrated, with a few exceptions, to be overwhelmingly safe as compared to both foods and pharmaceutical drugs.

A 2008 study entitled Dietary Supplement Adverse Effects found that "Most supplement-related adverse events were minor. Clinically significant toxic effects were most frequently reported with caffeine and yohimbe-containing products."

As with any other product on the market, an individual, or group of individuals, may assert that a dietary supplement has caused harm. This assertion may be made to a court, to a regulatory body, and/or directly to a dietary supplement manufacturer. Dietary supplement manufacturers must submit to FDA all reports that they receive of serious adverse events associated with a product that they manufacture. Dietary supplement manufacturers must also keep records of adverse event reports and provide FDA with access to these records upon request.

In 2009, FDA received 1,275 adverse event reports on dietary supplements. By comparison, FDA received nearly 600,000 adverse event reports on drugs during the same period. Notable recalls from 2009 include a large recall of beef products manufactured by Cargill for contamination with an aggressive strain of Salmonella, a Salmonella outbreak traced back to the Peanut Corporation of America, and a recall of refrigerated cookie dough by Nestle after some was found to have been contaminated with E. coli.

In 2010, FDA received over 750,000 adverse event reports on pharmaceutical drugs. A massive recall of Children's Tylenol was also issued in 2010 by Johnson and Johnson. McNeil recalled Motrin, and Pfizer recalled Lipitor, both for defective products manufactured outside the 50 states.

The largest egg recall in US history hit in August 2010 of 550 million eggs potentially infected with salmonella. The eggs were linked to more than 1,900 cases of illness, according to the Centers for Disease Control and Prevention (CDC). Kellogg's also recalled 28 million boxes of cereal for reports of foul odors.

When compared with the exposure of the public to these risks from food and drugs, the relative danger of dietary supplements appears miniscule. Yet real risks do exist- many of them related to concurrent use with pharmaceutical medications.

Quality of Manufacturing

The public feels that dietary supplement manufacturers should be open, honest, and transparent with manufacturing practices. People want to know that what is on the label is in the bottle, and nothing more or less.

Quality assurance seeks to ensure that the process of developing and producing a dietary supplement meets certain criteria, while quality control seeks to ensure the safety and efficacy of a finished product prior to marketing. Generally, manufacturers register their facilities but do not register their products with FDA. With respect to this, DSHEA mandates that manufacturers abide by current Good Manufacturing Practices (cGMPs). cGMPs are the standard by which the FDA determines whether a dietary supplement company is fulfilling its responsibility for safety. The specific section of the Code of Federal Regulations (CFR Title 21) that is applicable to dietary supplements is Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.

Integrity of Marketing

The public feels that advertising and promotional materials regarding dietary supplements should not be false or misleading. Dietary supplement manufacturers are also restricted from making claims that have not been substantiated with scientific evidence.

In a nutshell, manufacturers are only permitted to make certain types of claims, and may not make false or misleading claims of any kind. The types of claims that dietary supplement manufactures make fall into three basic categories: health claims, nutrient content claims, and structure/function claims. Disease-related claims are generally not permitted for dietary supplements, and the FDA requires a dietary supplement label to contain a disclaimer specifying "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."

Health Claims

With respect to health claims, these describe a relationship between a dietary supplement ingredient and a reduction in the risk of a disease or health-related condition. The Nutrition Labeling and Education Act (Rep. Henry Waxman, D-CA) (NLEA) authorizes the FDA to issue regulations after review of the scientific evidence submitted in health claim petitions. The Food and Drug Administration Modernization Act (Sen. James Jeffords, I-VT) authorized health claims based on an authoritative statement of a scientific body of the U.S. government with official responsibility for public health protection or research directly related to human nutrition, or the National Academy of Sciences. There are also "qualified health claims" that are not authorized, but supported by credible evidence. Qualified health claims must also be accompanied by a non-misleading disclaimer.

Nutrient Content Claims

Nutrient content claims, such as "Low Fat" or "High Fiber" describe the relative level of a component as compared to similar products and are permitted under NLEA. This ensures that the terms used in nutrient content claims are consistent with those of food products.

Structure/Function Claims

Finally, structure/function claims, such as "Supports Healthy Bones" or "Supports Healthy Digestion" describe the role of a nutrient or dietary ingredient as it impacts normal structure or function in humans or a nutrient deficiency disease. In this respect, structure/function claims are regulated more consistently with those of pharmaceutical drugs.

Current Trends and Regulatory Practices

The dietary supplement industry has demonstrated tremendous growth, despite severe economic downturns. No doubt it will continue to look attractive to unscrupulous people seeking to get ahead using business and manufacturing practices that are generally considered to be inappropriate. Naturally, the public will want to protect itself from these individuals, and the FDA is a public agency that is charged with expressing this aspect of public will.

In light of the fact that FDA has been given so much broad authority by the government, it is a natural target for politicians and lobbyists acting in the special interests of competitors to dietary supplement companies. The general strategy of special interests groups is to exploit the public will in order to achieve a competitive advantage in the marketplace.

This is accomplished by capitalizing on news of regulatory failure, such as contamination of a dietary supplement with a steroid hormone, and spinning it in such a way as to generate calls for more regulatory oversight of dietary supplement manufacturers in general. One tactic used to achieve this goal is to propagandize as to make it appear that dietary supplements are not sufficiently regulated under DSHEA. Due to the limited resources available to the FDA for discharge of its duties, this shift of regulatory attention away from competitors and toward dietary supplement companies, benefits special interests while appearing to benefit the public.

Next, we shall review how DSHEA and the FDA already regulate dietary supplements according to the three principles outlined above.

In June 2007, FDA promulgated a final rule establishing these cGMPs, aimed at avoiding wrong ingredients; too much or too little of a dietary ingredient; improper packaging; improper labeling; or contamination problems. To abide by the rule, manufacturers are required to evaluate the identity, purity, quality, strength, and composition of dietary supplements.

Violations of the regulations are violations of the law and can lead to both civil and criminal penalties. The rule went into effect in June 2008, and since that time the majority of facilities inspected by the FDA have been found to be in substantial compliance.

Dietary supplements may be marketed without FDA approval, unless they contain a novel ingredient that wasn't already in use before DSHEA was enacted in 1994. In this case, a manufacturer must submit a notification to FDA before it markets a dietary supplement containing a New Dietary Ingredient (NDI). To this end, the law requires a premarket submission of data and information regarding the safety of the product. Although there is currently no authoritative list of ingredients are pre-approved, the FDA is developing a guidance document to evaluate an NDI.

The dietary supplement industry is also self-regulated by three additional mechanisms outside of the FDA's control.

Research and Education

The first is through relationships that dietary supplement manufacturers develop with research and educational institutions as well as directly to health professionals. Reputable dietary supplement companies reach out to health professionals through educational materials and seminars. Typically they have physicians that work for them in various educational, development, and advisory roles. They may also contribute substantially or financially to scientific research on the safety and efficacy of dietary supplements.

Industry Standards and Best Practices

The second is through dietary supplement distributors and trade organizations that develop their own internal standards of quality by which the manufacturers must be verified. Examples of this would include the dietary supplement distributor Emerson Ecologics, which independently developed a quality program, as well as the Natural Products Association which offers additional standards and certification processes.

Human Resource Management

The third is through human resource management. Reputable dietary supplement manufacturers may source quality assurance and quality control personnel from pharmaceutical or medical device manufacturers, which are generally subject to more restrictive regulation.

Regulatory and Legislative Trends

The FDA has limited resources available to discharge its duty to enforce regulatory authority, and continues to receive harsh criticism of its ability to perform its function. As the FDA grows in unpopularity, proposed legislation seeks to address this issue in varying ways.

Two bills were introduced during the 111th session of Congress. The Dietary Supplement Safety Act (Sen. John McCain, R-AZ) sought to expand regulatory authority over the dietary supplement industry while the DSHEA Full Implementation and Enforcement Act (Sen. Thomas Harkin, D-IA) sought to shift FDA regulatory activity more toward dietary supplement manufacturers. Neither of these bills made it to a vote.

Two bills were introduced during the 112th session of Congress. The Dietary Supplement Labeling Act (Sen. Richard Durbin, D-IL) seeks to require manufacturers of dietary supplements to register dietary supplement products with the Food and Drug Administration and to amend labeling requirements with respect to dietary supplements. The Dietary Supplement Protection Act (Rep. Dan Burton R-IN5) seeks to to amend the Federal Food, Drug, and Cosmetic Act concerning safe dietary ingredients in dietary supplements.

Currently, the FDA focuses enforcement actions related to dietary supplements on three areas that pose the greatest risk to public health: adulteration with drug substances, illegal claims, and unsafe ingredients.

Adulteration With Drug Substances

Adulteration with drug substances has been most commonly associated with dietary supplements marketed for sexual enhancement or erectile dysfunction, weight loss, cholesterol reduction, and body building. These products are often sold with misleading labeling and are frequently manufactured without quality controls.

Illegal Claims

The FDA is concerned that illegal claims may encourage consumers to self-treat for a serious disease without first consulting with a qualified health professional. Certain dietary supplement manufacturers have responded to this trend by self-restricting distribution of their products only to individuals that are consuming those products under the advisement of a qualified health professional.

In a particularly controversial move, the FDA launched a joint investigation of illegal claims along with the Federal Trade Commission (FTC) in response to approximately 70 dietary supplements which were being promoted to treat, prevent, or cure the H1N1 flu in 2009. Previously, the FDA and FTC had not acted in conjunction on such matters.

Unsafe Ingredients

DSHEA empowers the HHS Secretary to ban a dietary supplement if it is found to be an imminent hazard to health. Dietary supplement manufacturers are otherwise subject to enforcement action if a product was found to contain a known deleterious substance, or if it presents a significant or unreasonable risk to consumers.

As many dietary supplements contain numerous ingredients, and the exact formulation may be protected as proprietary information, there is a significant challenge presented to identify causal connections between specific ingredients and adverse effects. In 2009, the manufacturer of the weight loss supplement Hydroxycut issued a massive voluntary recall following reports of serious liver injuries associated with its formulation at the time.

Government Accountability Office Involvement

Late in 2009, the FDA made a request to the Government Accountability Office (GAO) to conduct an investigation into the manufacturing and marketing of dietary supplements, with special focus on botanical products. The GAO investigators found a number of claims involving promised cures for diseases which appeared to cause certain products to be illegal.

GAO also analyzed 40 dietary supplements for heavy metal contaminants, and found some levels to be concerning, though stated that they do not represent a significant risk to health. The 40 dietary supplements were chosen from a combination of retail chain storefronts and online merchants based on popularity. It is significant to note that the GAO did not choose dietary supplements based on the reputation of the manufacturer among trained health professionals, and among its peers.

GAO also analyzed supplements for pesticide residues and compared the results to levels determined to be safe by the Environmental Protection Agency (EPA) for dietary supplements. In cases where a reference range had not been established for dietary supplements, the EPA used the standards for fruits and vegetables. Of the 40 dietary supplements tested, three violations were found for the presence of carbofuran, toclofos-methyl, and hexachlorobenzene (HCB).

Freedom of Science Information Movement

Efforts have also been underway to alter the means by which the FDA and the FTC regulate the functional foods and dietary supplement industries. During the 111th session of Congress, two bills were introduced to these ends. The Health Freedom of Speech Act (Rep. Ron Paul, R-TX) and the Free Speech About Science Act (Rep. Jason Chaffetz, R-UT), sought to amend the Federal Food, Drug, and Cosmetic Act and the Federal Trade Commission Act, respectively. Neither of these bills made it to a vote, however both were re-introduced in the 112th session.

Conclusions

The FDA is already empowered with broad authority over the regulation of dietary supplements through the Dietary Supplements Health and Education Act (DSHEA) and the Nutrition Labeling and Education Act (NLEA). Dietary supplement manufacturers are held to standards similar to their closest peers, food manufacturers and pharmaceutical companies.

In 2009, the FDA reached out in partnership to both the FTC and GAO for assistance in discharging its duties. Some take this as a sign of more efficient government practices. Others view this as a demonstration of the FDAs incompetence and/or impotence to enforce the law, especially when considered against the larger background of drug recalls and outbreaks of food-borne illness.

A small portion believe that these actions represent a collusion between government agencies, food producers, and pharmaceutical companies to suppress scientific research, and promote a hidden agenda whereby food companies and pharmaceutical manufacturers are permitted to sell products that are harmful to the public, while simultaneously restricting access to products that provide a legitimate health benefit.

Looking to the future, it is clear that each of these groups will continue to voice their concerns ever more forcefully. Although it is certain that the FDA will never meet everybody's demands or expectations, the solutions put forth fall into five general categories. We conclude with a brief summary of each.

Increase direct funding to the FDA. Proponents of this method are generally characterized as FDA sympathizers who observe that the FDA has been charged with a duty, but disallowed the resources to fulfill its function properly. Opponents identify increased funding as bigger government and increased taxes.

Expand existing FDA authority. Proponents of this method either aren't aware of the full scope of FDA authority, or feel that the scope too restrictive for the FDA to effectively regulate. Detractors point out that expanding FDA authority without increasing its funding would likely result in greater levels of incompetence and failure.

Increase support for interagency regulatory efforts. Proponents observe that further cooperation between agencies cuts back on wasteful spending secondary to duplicate efforts and ineffectual enforcement. Critics of this method point out that promotion of interagency cooperation can lead to greater centralization of power and levels of government control that are not directly accountable to the People.

Disband the FDA into several smaller agencies. This method has not gained much traction in public forum, and is considered by many to be somewhat extremist. Proponents point to the demonstrated incompetency of the FDA to discharge its duties and its susceptibility to special interests and insider manipulation as a motivator for disbandment.

Deregulation of the dietary supplement industry. Opponents to this method observe that deregulation of industry, especially during a growth phase, can result in increased harm to the public. Proponents point out that the industry has already demonstrated itself to be capable of self-regulation, and that agency resources would best be applied toward efforts that are of higher urgency and priority.

Dr. Matthew Marturano offers naturopathic medicine for holistic health and wellness. He serves on the Board of Directors for the Michigan Association of Naturopathic Physicians and is the Director of Strategic Development for Orchid Holistic Search.