Ephedra: A Costly Victory?

A review of permitted claims for dietary supplements and the implications of the recent ephedra ruling.

By Todd Harrison

When Congress enacted the Dietary Supplement Health and Education Act (DSHEA) in 1994, one of its main purposes was to encourage more public awareness regarding the health benefits associated with taking certain nutrients and botanicals. However, these health benefits were not limited to health maintenance and disease prevention, but were also seen as a means of treating various diseases. Indeed, Congress intended to encourage research into natural remedies as potential treatments and where the research indicated that the remedy would be useful in the treatment of a disease that licensed healthcare practitioners would indeed prescribe these natural remedies to their patients. Congress envisioned that individuals would not only take dietary supplements to improve their overall health but to also assist in the treatment of any medical condition they suffered from. However, Congress was also aware of the need to strike a balance between drugs and dietary supplements, as well as the type of claims that could be made for dietary supplements without causing them to be unapproved new drugs. This balance was struck in two ways.

First, Congress expressly permitted the use of structure/function claims, (e.g., “helps maintain a healthy heart”). FDA issued its final rules regarding structure/function claims on January 6, 2000. To some, those rules were too broad and permitted too many claims that border on disease treatment claims. However, the reality is that FDA has strictly interpreted these rules to exclude a broad range of structure/function claims that Congress envisioned could be made for dietary supplements. FDA's position can be boiled down to the following: “any claim no matter how remotely it may be related to a disease is an impermissible structure/function claim.” While this position is rather restrictive, in practice, the agency has had limited resources to aggressively pursue companies that even the industry would concede have clearly crossed the line.

The second avenue open to dietary supplement companies that wished to make more aggressive claims regarding dietary supplements was the “reading room” exception, or third party literature. This exception permitted manufacturers and distributors of dietary supplements to distribute information, in the form of a publication, to the public regarding the health benefits of dietary ingredients even if the publication, by way of example, informs the public that glucosamine sulfate is a useful treatment for arthritis.

For a publication to fall within the reading room exception, it must meet the following conditions:
• The information in the publication must be truthful and non-misleading;
• The publication cannot promote a particular brand or manufacturer of the dietary ingredient;
• The publication must be displayed or presented in such a manner that it presents a balanced view of the scientific evidence;
• The publication if displayed in an establishment must be physically separated from the dietary supplement; and
• The publication must not have anything appended, whether by sticker or another method, to it that refers to a particular dietary supplement.

The reading room exception has its drawbacks. Determining what is an acceptable publication is often difficult. Clearly, the majority of peer reviewed scientific articles would meet this standard. However, a company would need to seek permission to reprint the article if it is not available in the public domain and these articles are generally not consumer friendly. Thus, a company will need to have drafted its own publication that is not only consumer friendly, but also meets the standards previously mention. This, however, leads us to the biggest drawback of the reading room exception and that is the publication cannot refer to a particular manufacturer or brand of dietary supplement. Thus, if even though a company may have conducted clinical trials on a St. John's Wort extract for the treatment of clinical depression, it cannot refer to its product name in the consumer friendly research publication that a company would want to disseminate to customers at the local health store.

One way to remedy this issue, however, is by using a reference room or reference library on the company's website. Unfortunately, this method of disseminating information may not be the most effective, especially if the company’s website is not a retail site. Moreover, FDA may take the position that websites cannot be used to disseminate disease treatment information regarding a particular dietary ingredient.

Another possible avenue is consumer advertising. However, keep in mind that besides the FTC risk involved in making claims, FDA can use traditional advertising media, (e.g., television, radio, magazines, and newspapers) to establish the intended use of the product. Moreover, often claims that appear in traditional advertising media will also show up in catalogs, brochures, pamphlets, etc., that FDA does consider to be labeling. Whether FDA is inclined to use advertising materials to establish the intended use of a supplement as a drug will largely depend on the type of claims being made for the product. As a practical concern, FDA is more likely to invoke “intended use” when the product is being promoted for a serious condition, (e.g., cancer, heart disease, AIDS) than minor conditions (e.g., colds, allergies). Thus, advertising claims only further beg the question of how a dietary supplement company can disseminate truthful and non-misleading disease treatment claims for its products. One potential solution is to provide the information directly to licensed healthcare professionals such as physicians. To provide information in this manner, the company will need to rely on the reading room exception to a certain extent, as well as the First Amendment.

As previously discussed, the purpose of the reading room exception is to permit the dissemination of scientific information to the public regardless of whether the information encourages the use of a dietary ingredient in the cure, treatment or prevention of a disease. However, the type of articles that are likely to survive scrutiny by FDA may be difficult to understand and cannot mention specific products. An alternative way to use the reading room exception is to provide the science based publication to licensed healthcare practitioners that have an interest in natural remedies and are likely to recommend dietary supplements as a therapy or adjunct therapy to their patients. These well schooled individuals will be able to understand the publication and make a sound decision of whether a particular nutrient or dietary ingredient is beneficial to their patients. Moreover, while FDA may disagree, there is no reason why the company providing the information cannot disclose its identity in a cover letter to the physician or at the beginning or end of the research paper. Indeed, if the company is providing an actual peer-reviewed scientific article on its particular product, there is no reason that the brand name of the supplement be redacted from the article. Thus, the distribution of truthful and non-misleading scientific information directly to healthcare practitioners is potentially another avenue to build brand recognition. Of course, there is some regulatory risk involved, but that risk is minimized if the publication being provided is truthful, non-misleading and balanced. As such, it would be best to provide actual articles that have been published or the results of actual “gold standard” clinical trials on the product itself.

The Regulatory Ramifications of the Recent Ephedra
Ruling in Utah

The regulatory scheme for dietary supplements, however, may be in jeopardy due to a recent ephedra decision made by a U.S. district court in Utah.Unfortunately, the court’s decision is likely to play into the hands of the enemies of DSHEA and provide the impetus for Congress to strengthen FDA’s already substantial regulatory authority over dietary supplements. One has to wonder why this case was brought in the first place since the insurance industry had effectively removed most ephedra products from the marketplace prior to FDA’s decision to prohibit the sale of dietary supplements containing ephedra. Moreover, it is unlikely that the insurance industry will issue low to moderately priced product liability insurance that covers low-dose ephedra products. From a regulatory perspective, the FDA, in connection with the FTC, will likely take regulatory action against companies that make any types of claims, especially for weight loss because the scientific evidence supporting the use of less than 10 milligrams of ephedra per day is utterly lacking. In essence, the plaintiff received a very hollow victory for the industry that may very well end up providing FDA with even greater regulatory authority over the supplement industry, while the FTC seeks to fill the void created by the court’s decision by stepping up its already aggressive policing of the supplement industry. A pyrrhic victory, INDEED!NW