Todd Harrison04.01.04
Better To Be Safe Than Sorry
Confirming the safety of a supplement is crucial in order to operate in today’s marketplace.
By Todd Harrison
Recently, FDA moved to start prohibiting the sales of dietary supplements containing ephedrine alkaloids. FDA’s move has been applauded by consumer advocates and the popular media. While FDA’s decision is subject to court challenge, its decision to prohibit the sale of ephedra dietary supplements is probably more show than anything else. Indeed, the ephedra dietary supplement industry, beset with product liability cases, had already effectively stopped marketing ephedra dietary supplements. Furthermore, most of the major players had already reformulated their weight loss and energy supplements to remove Ma Huang or ephedra as an ingredient. Moreover, legitimate smaller suppliers would have likely been forced to reformulate because insurance companies were refusing to provide coverage to such products. So, it would appear that FDA’s efforts were unnecessary as the marketplace had already made a decision that marketing ephedra dietary supplements was a bad business decision. Yet, consumer advocates and the popular press continue to press for changes in the Federal Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act (“FFDCA”), which would require FDA’s approval of dietary ingredients. However, the FFDCA already prohibits the distribution of dietary supplements that pose a significant or unreasonable risk of illness or injury under its intended conditions of use.
To the extent that it is difficult to decipher what is considered a significant or unreasonable risk of harm, the answer is not more legislation. Rather, general guidelines should be established by the industry in close consultation with FDA and other scientific agencies. Unfortunately, FDA continues to be unwilling to go down this road. The agency continues to take the position that the safety of dietary supplements is primarily an industry concern. This places the industry in a tenuous position because the product liability plaintiff’s bar is jumping on this vagueness to require a level of safety for dietary supplements that would be difficult for any industry to obtain. This raising of the bar on safety places all supplement companies at risk if they have not done their homework, which is made more difficult by FDA not providing any guidance on the issue of safety although it has the regulatory authority to do so.
This lack of guidance leaves the decision of whether to market a particular dietary ingredient or combination largely dependent on the professional judgment of the company marketing the product. Thus, a company must take due care in developing and formulating its products. It should review all the relevant safety information on a particular ingredient(s). This evaluation includes understanding the chemical structure of the ingredient, its traditional uses, available toxicological data and potential contraindications, as well as any other data that will shed light on the ingredient’s safety. Only after a company has determined that the ingredient and/or formulation is safe for human consumption should it market the product. Indeed, failure to adequately determine the safety of a particular product leaves a company vulnerable to a civil lawsuit for damages if the product is determined to be unsafe. All distributors and manufacturers of dietary supplements should maintain a safety file on all of their product formulations and provide adequate product warnings on the label. Failure to do so will leave the company vulnerable to a significant damage award in a civil lawsuit.
One aspect of safety that appears to be ignored is that of new dietary ingredients. New dietary ingredients appear to be proliferating without a significant increase in new dietary ingredient notifications. To market a dietary ingredient without notification, the dietary ingredient must have been sold in the U.S. prior to October 15, 1994, or available in the food supply in chemically unaltered form. Under the FFDCA, the failure to file a new dietary ingredient notification renders the product adulterated unless there is some evidence that the dietary ingredient has been marketed as a food.
For example, many of the new herbal dietary ingredients appear to have been used by other cultures as medicine. However, because the herbs were not consumed as food, they are not exempted from the notification provisions of the FFDCA. Indeed, products containing these ingredients are adulterated and subject to regulatory action, including seizure. Moreover, the failure to truly document the safety of these new herbal ingredients leaves the company vulnerable to product liability suits if someone is injured as a result of consuming the new dietary ingredient.
This practice of not filing a new dietary ingredient notification is a bit foolhardy when one considers that the requirements of the notification are hardly onerous and are truly designed to ensure the ingredient does not pose an unnecessary risk. These requirements include:
1. The name and complete address of the manufacturer or distributor of the dietary supplement containing the new dietary ingredient.
2. The name of the dietary ingredient, including its Latin binomial name if it is an herb or other botanical.
3. A description of the product(s) that will contain the new dietary ingredient, the level in which it will appear in the product(s) and its recommended or suggested conditions of use.
4. Information regarding the safety of the ingredient, including toxicological data, history of use in other cultures and any other information that will shed light on the safety of the dietary ingredient, including published scientific articles (English translations must be submitted with any articles that are submitted in a foreign language).
5. A person designated by the company must sign the premarket notification.
Upon receiving the notification, FDA will notify the submitter of the date of receipt. At the conclusion of 75 days from this date, the company may start marketing the ingredient unless FDA notifies it otherwise. If FDA requests additional substantive information, it will assign a new filing date to the notification and the 75 day period starts anew. Of course, the failure of FDA to respond within 75 days does not mean that FDA considers the new dietary ingredient safe. Rather, it only means that the company may move forward at its own risk. Thus, the company should be relatively confident that the available scientific evidence demonstrates that its new dietary ingredient is safe before it begins to market it.
Failure to adequately address the safety of any dietary ingredient or food ingredient can have a devastating financial impact on a company if someone is injured. Indeed, plaintiff attorneys across the U.S. are filing more and more lawsuits against supplement companies because they are viewed as easy targets. The target is made especially easy when the company markets its products as safe and natural. Companies should avoid making safety claims if they have not done their homework on safety. Moreover, if the industry as a whole does not voluntarily address the issue of safety, consumer advocates will have their way and there will be tighter regulation of dietary supplements.NW