Avoiding Regulatory Pitfalls: GRAS, NDIs and Border Detention

Getting a product through all legal/regulatory requirements and off to the consumer is no small endeavor. Smart manufacturers pay attention to potential pitfalls that can sideline their products, costing their companies time and money. All companies should know how to reduce legal and regulatory risks. Three hot-button, under-the-radar issues are: 1) red flags raised about the GRAS (generally recognized as safe) self-affirmation process; 2) what triggers the need for a new dietary ingredient (NDI) notification; 3) and why so many incoming ingredients are getting stuck at U.S. borders.

GRAS Under Scrutiny

There’s new scrutiny about how to establish ingredients as GRAS. Recently, the Natural Resources Defense Council (NRDC), an activist group, released a critical report on GRAS exemptions, asserting it’s a secretive process designed to pass through most new chemicals. Although the food industry is the primary target, dietary supplements also appear to be a key concern for this group. The report claims the Dietary Supplement Health and Education Act of 1994 (DSHEA) creates “separate, less rigorous standards for dietary supplements" and calls for FDA and Congress to change the process. CRN and respected legal experts find fault with the report, but our industry needs to understand where the pitfalls in this area lie.

More NDI questions

If an ingredient is GRAS for certain conditions of use, then there is no need to file an NDI for similar conditions when used in a dietary supplement. But when an ingredient has not been through the GRAS process, there’s been controversy between FDA and some in the industry as to how to interpret when an ingredient is considered to have been in the food supply, and therefore not requiring an NDI notification. For example, synthetic lycopene did not need an NDI because it went through the GRAS process and then was added to the food supply. But if it hadn’t, according to FDA, the presence of lycopene in a tomato would not have passed muster as consideration for having been in the food supply. A more publicly controversial example is dendrobium, the ingredient found in pre-workout supplements claimed to boost athletic performance. An NDI was never submitted, as manufacturers claim dendrobium is found in dendrobium orchids, and therefore in the food supply. FDA’s recent warning letter made the agency’s position clear: even if people eat dendrobium orchids, the compound dendrobium is not the actual article of the food and consequently, is considered an NDI, requiring notification. As we watch how these regulations play out, if a company isn’t sure if something has been in the food supply and want to include it in a dietary supplement, it’s safest to file an NDI.

Stuck at the border

What do you do if your product is detained at a U.S. border? More importantly, what can you do to help ensure it doesn’t get stuck in the first place? Prior to the Food Safety Modernization Act (FSMA), FDA was required to have actual evidence of adulteration in order to detain a shipment; under FSMA, FDA has increased authority, needing only a “reason to believe that an article of food is adulterated or misbranded." There are best practices that can help you avoid detainment. One example: even if an ingredient is sold as an Approved Pharmaceutical Ingredient (API) in Europe, if a company imports it as a dietary supplement in the United States, any accompanying paperwork that indicates it’s used as a drug could raise the eyebrows of an FDA field officer, which in turn could stop the product in its importation tracks. Another tip: if FDA detained a product, an immediate response is required to avoid listing on a publicly published Import Alert violations list. Once a product is listed, FDA is allowed to detain every shipment of that ingredient/product. For companies with ingredients and products moving around the world, problems at borders are costly, so it pays to understand best practices ahead of time to avoid detainment.

Register here for the CRN/VIRGO webinar on June 11 for more expert analysis on these issues.

Duffy MacKay, N.D., is senior vice president, scientific & regulatory affairs for the Council for Responsible Nutrition (CRN, crnusa.org), a trade association for the dietary supplement industry.