Did the Ephedra Ban Mark a New Era of Dietary Supplement Regulation at the FDA?

In the weeks surrounding the ban of ephedra, which took effect on April 12, it appears that the Food and Drug Administration (FDA) has stepped up efforts to monitor the dietary supplement industry and enforce the Dietary Supplement Health and Education Act of 1994 (DSHEA). With the stated goals of making more and better information about foods and dietary supplements available to American consumers and protecting consumers from products bearing false or misleading claims, the FDA seems to be laying groundwork for the possibility of additional product bans and support for more restrictive legislation.

Below is a selection from recent FDA press releases, documenting the increased attention the dietary supplement industry is receiving. For more information on any of these releases, please visit the FDA web site at:

FDA outlines science-based plan for dietary supplement enforcement

Speaking before the American Society for Pharmacology and Experimental Therapeutics and the American Society for Nutritional Sciences, Lester M. Crawford, DVM, PhD, Acting Commissioner of the FDA, outlined on April 19, 2004, the agency’s science-based approach to protecting American consumers from unsafe dietary supplements.

Crawford said the agency would soon provide further details about its plan to ensure that the consumer protection provisions of DSHEA are used effectively and appropriately. Through DSHEA, which sets up a distinct regulatory framework for dietary supplement products, Congress attempted to strike a balance between providing consumers access to dietary supplements and giving FDA regulatory authority to act against supplements or supplement ingredients that present safety problems, are marketed with false or misleading claims, or are otherwise adulterated or misbranded.

"FDA is absolutely committed to protecting consumers from misleading claims and unsafe products," said Crawford. "Unlike most foods, some dietary supplements are pharmacologically active. And we have seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose."

Over a period of six months, FDA has inspected 180 domestic dietary supplement manufacturers; sent 119 warning letters to dietary supplement distributors; refused entry to 1,171 foreign shipments of dietary supplements; and seized or supervised voluntary destruction of almost $18 million worth of mislabeled or adulterated products. "We will continue to aggressively enforce DSHEA against unsafe or mislabeled products," Crawford said.

Over the next several months FDA will provide additional information to explain and implement the tools available to the agency under DSHEA to act against unsafe supplements and false or misleading supplement labeling claims.

FDA is also developing regulations for industry on good manufacturing practices. When finalized, this rule, proposed in the spring of 2003, will help protect consumers from dietary supplements that contain impurities or contaminants as a result of how they are manufactured or handled.

In addition, FDA is more closely scrutinizing dietary supplement labeling. Dietary supplement labels cannot claim the supplement will treat or cure a disease, and since December 2002 FDA has worked with the Federal Trade Commission to challenge false claims of supplement effectiveness for treating a range of diseases.

To support its consumer protection actions, the agency is developing approaches to systematically review the evidence about the safety of individual dietary supplements. FDA expects to evaluate the available pharmacology, published literature (including animal, in vitro, epidemiological, and clinical trial data), evidence-based reviews, and adverse event information—the approach that formed the scientific foundation for FDA’s recent rulemaking on ephedra.

FDA warns distributors of dietary supplements promoted on-line for weight loss

On April 1, 2004, the FDA sent warning letters to 16 dietary supplement distributors making false and misleading claims for weight loss products promoted over the internet.

"Obesity in America is at epidemic proportions, and we will not tolerate companies making false claims promising easy fixes," Health and Human Services (HHS) Secretary Tommy G. Thompson said.

Many of these products claim to block starch, carbohydrates, and fat calories, while allowing consumers to lose weight without any changes in lifestyle. "These products give unfounded hope to people who are attempting to lose weight. False and misleading claims have significant health consequences to individuals that may be overweight because these products do not produce the desired results," said Crawford. "FDA will continue to enforce the law and pursue products that lure consumers with unsubstantiated weight loss claims."

Although dietary supplement labeling may include claims about the supplement’s effect on the structure or function of the human body, the law requires that structure/function claims must have substantiation and be truthful and not misleading. After reviewing the claims of the various products, FDA concluded that claims being made regarding these products are not supported by reliable scientific evidence.

FDA requested a response from the firms in writing within 15 days of receipt of the warning letters stating the action the firms will take to correct the noted violations and to ensure that similar violations do not occur in the future.

HHS launches crackdown on products containing androstenedione

On March 11, 2004, HHS Secretary Tommy G. Thompson announced a crackdown on companies that manufacture, market, and distribute products containing androstenedione ("andro"), which acts like a steroid once it is metabolized by the body and therefore can pose similar kinds of health risks as steroids. These products are generally advertised as dietary supplements that enhance athletic performance based on their claimed anabolic and androgenic properties to stimulate muscle growth and increase production of testosterone.

As part of the crackdown, the FDA sent warning letters to 23 companies asking them to cease distributing dietary supplements that contain androstenedione and warning them that they could face enforcement actions if they do not take appropriate actions.

"While andro products may seem to have short-term benefits, the science shows that these same properties create real and significant health risks," said FDA Commissioner Mark B. McClellan, PhD, MD. "While the products are advertised to athletes, they have the potential to get into the hands of our impressionable youth who may believe these products will help their development. Anyone who takes these products in sufficient quantities to build muscle or improve performance is putting himself or herself at risk for serious long-term and potentially irreversible health consequences. There is no proven safe substitute for hard work and training when it comes to improving athletic skill ... ."

Secretary Thompson also encouraged Congress to pass legislation sponsored by Senators Orrin Hatch and Joe Biden and Representatives James Sensenbrenner, John Sweeney, and John Conyers, Jr., that would classify andro-containing products as a controlled substance. Such legislation would enable the U.S. Drug Enforcement Agency (DEA) to regulate these types of products as anabolic steroids under the Controlled Substances Act. HHS and DEA are providing technical assistance to the Senators and Congressmen as they pursue such legislation.

FDA will determine whether further actions are necessary if firms refuse to cease distribution of these products. Such actions could include seizing violative product as well as pursuing injunctions or seeking criminal sanctions against persons who violate the law.