Dietary Supplements | Bulk Ingredient Safety

Dietary supplements in the United States are regulated as foods, not as drugs. While pharmaceutical companies are required to obtain FDA approval related to the safety or effectiveness of their drug products prior to distributing them in the U.S. market, generally dietary supplements, like foods, do not have an FDA approval requirement. However, there are FDA regulations and restrictions of certain substances for use as dietary ingredients in dietary supplements because of safety concerns. If your product is in violation of these regulations/restrictions, the FDA may take action against your company.

All importers of food products intended for introduction into U.S. interstate commerce are responsible for ensuring that their products are safe, sanitary, and labeled according to the Food Drug and Cosmetic Act (FDCA) requirements. Although the dietary supplement manufacturer or distributor must ensure the safety of its products, in order for FDA to bring an action against a dietary supplement already on the market, FDA bears the burden of proof (FDA must demonstrate) that a supplement is unsafe. FDA also conducts certain post-marketing surveillance of dietary supplements on the market, by receiving FDA Center For Food Safety and Nutrition (CFSAN) Adverse Event Reports in their reporting System (called CAERS).

These requirements all apply to dietary supplement bulk ingredient distributors and dietary supplement importers alike. nder the FDCA, FDA must have evidence that a dietary supplement or a dietary ingredient is unsafe before certain regulatory and legal remedies become available to the agency with respect to the product. However, for imported bulk dietary ingredients, the level of evidence is very low (only the “appearance” of a violation is necessary to produce an FDA import detention, an FDA Import Alert, or an FDA import refusal).

FDA will at times become aware of certain new (or novel) dietary ingredients that have been reported in medical or research journals as having some safety risks associated with them, for instance, risks related to liver damage or kidney damage, or ingredients that may show some cancer causing risks in lab animals at high doses. If FDA is particularly concerned about these risks, the ingredient is relatively new, and no new dietary ingredient notification has been submitted to FDA (as may be required by the FDCA or FDA regulation), the agency will detain imported shipments of the bulk dietary ingredients alleging they appear to be unsafe. In most cases, FDA will argue that the manufacturer or distributor of the ingredient should submit a new dietary ingredient notification to give FDA the opportunity to assess the firm’s evidence that the ingredient is reasonably expected to be safe. However, for bulk dietary ingredients, there often is insufficient information about the intended use or even final formulation of any finished dietary supplements the dietary ingredient might become a part of.

In these cases, it is critical to have on your side a team of experts who understands how FDA regulates dietary supplements and dietary ingredients and how FDA and Customs import authorities operate to find resolution, if it is at all possible., LLC has often succeeded in obtaining the release of imported bulk dietary supplement ingredient shipments detained by FDA on the grounds described here – but not always. Sometimes FDA is committed to keeping a dietary ingredient out of the U.S. market if that is at all possible. Therefore,, LLC clients have an advantage because we have already shown The Way Through such obstacles and are able to help our clients avoid unnecessary FDA import detentions and FDA import refusals.

We have solutions for every type of client. If you are simply starting up or contemplating a new venture and would like to know the expenses, time frames and possible risks, talk to us. If you are a multi-national firm that has completed this process hundreds of times before, we can help you as well. The ever-changing nature of the laws surrounding consumer goods such as Food, Dietary Supplements, Drugs and Cosmetics requires experts who stay on top of all of the changes and proactively counsel with clients to ensure top profitability and lowest amount of downtime.

FDA, LLC is a full-service regulatory consulting firm with substantial experience in the field of dietary supplements. Let us show you The Way Through and demonstrate how well the process can work when you have the right people backing up your critical business decision-making.