Todd Harrison01.01.02
Introducing New Dietary Ingredients
Assessing regulatory risks and requirements.
By Todd Harrison
Recent events in Germany regarding the safety of kava kava have once again thrust the safety of dietary supplements, particularly herbal supplements, back into the spotlight. This recent event may cause the popular media to once again call for tighter regulation of dietary supplements. However, more regulation is not what is required. Admittedly, while the food additive provisions of the Federal Food, Drug and Cosmetic Act (“FD&C Act”) are not applicable to dietary ingredients, this does not mean that dietary ingredients are not required to meet certain statutory safety standards. Indeed, a dietary supplement or a particular dietary ingredient cannot pose a significant or unreasonable risk of illness or injury under its intended conditions of use. This standard—the absence of proof of significant or unreasonable risk of harm—may be a lesser scientific threshold than what is necessary for a substance to receive food additive approval or be considered generally recognized as safe (GRAS) for human consumption, but it is still a rigorous standard that ensures the safety of dietary supplements.
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 the Food and Drug Administration (FDA) and other scientific agencies. Unfortunately, FDA does not appear willing to go down this road. Rather, it continues to take the position that the safety of dietary supplements is primarily an industry concern. This position becomes even more clear when you consider FDA’s position on “new” dietary ingredient (dietary ingredients first marketed after October 15, 1994) notifications.
In this regard, FDA has stated that DSHEA’s new dietary ingredient notification provisions merely provide a mechanism by which companies are required to notify FDA regarding the safety of such ingredients. Indeed, FDA refused to provide even minimal guidance regarding the threshold level of scientific evidence necessary to establish the safety of new dietary ingredients.
This lack of guidance leaves the decision of whether to market a particular dietary ingredient or combinationlargely 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.
Yet, the proliferation of new dietary ingredients continues without a significant increase in new dietary ingredient notifications. This calls into question whether only a small minority of companies are doing their homework before marketing a new dietary ingredient in the U.S. Failure to provide the necessary notification to FDA is not without potential ramifications. Under the Act, this failure renders the product adulterated unless there is some evidence that the dietary ingredient has been marketed as a food. It should be noted that FDA interprets this to mean that the dietary ingredient must have been marketed as a food in chemically unaltered form.
For example, many of the new herbal dietary ingredients appear to have been used by other cultures as medicine. However, because the herbs were notconsumed as food, they are not exempted from the notification provisions of the FD&C Act. 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.
The questions regarding the safety of dietary supplements will likely continue to be an issue. However, more regulation is not necessary. Rather, the vigilance of the industry in attempting to identify potential safety issues and acting on those issues is the best recipe for ensuring the safety of dietary supplements.NW