by Wes Siegner and Susan Matthees
Recent FDA actions foreshadow an increased regulatory focus on dietary supplements. In March, FDA issued what appears to be the first warning letter to a firm for violations of the federal dietary supplement GMP (good manufacturing practice) regulations. The warning letter marked a point of transition for the agency and industry, from developing and issuing the regulations to enforcing them. The warning letter is also a timely reminder that failure to comply with any GMP procedure, including even lack of one required signature, causes the products at issue to be adulterated and, therefore, unlawfully marketed. The letter provides insight into the types of issues on which FDA inspectors can be expected to focus, the types of testing FDA views as “adequate” to establish ingredient identity, as well as the types of corrective actions that the agency expects.
FDA also recently posted a compliance program for dietary supplements that provides critical insights on where the agency is likely to focus its dietary supplement enforcement resources in the coming year. Illustrating FDA’s institutional biases, the agency prioritizes inspections to focus more on “non-traditional” products and less on vitamins and minerals. The document also lists deviations from GMP requirements (among others) that can be expected to result in the issuance of a warning letter, quoted verbatim below:
- Lack of master manufacturing records or significant requirements not included;
- Lack of finished product release criteria or failure to test (all or subset of finished batches) or meet finished product release criteria critical to product safety and quality;
- For significant dietary ingredients, e.g. those that make up the bulk of the product, failure to establish specifications for incoming material or failure to conduct identity testing;
- No quality control review procedures or significant quality control procedures not implemented;
- No batch records; and
- Significant physical plant deficiencies.
In addition to addressing enforcement priorities, the document contains some new interpretations of regulatory requirements that should have first been communicated to industry in the Federal Register to permit industry comment in compliance with the agency’s Good Guidance Practices regulation. For example, the document states a new dietary ingredient (NDI) notification “only applies to the specific product of the manufacturer/distributor who submits the notice.” This means an NDI notification would have to be submitted even if the dietary ingredient that is the subject of the notification is identical to a dietary ingredient that has been the subject of a prior notification. This position not only requires prior notice and comment under FDA’s own regulations, it directly conflicts with FDCA section 413 and is therefore unauthorized by law.
The guidance for the first time acknowledges the statement of identity requirement for a dietary supplement can be fulfilled simply by the term “dietary supplement” or by statements other than “dietary supplement” (e.g., “herbal supplement”).
Industry should remember guidance such as this is not legally binding on FDA or industry. Nonetheless, the new guidance and the recent warning letter are further evidence of a stronger focus on dietary supplement inspections and imports, and signals increased FDA enforcement in this area.
The authors are with Hyman, Phelps & McNamara P.C., a law firm with primary practice focused on FDA and FTC regulatory and enforcement matters. Wes Siegner is a director at the firm and Susan Matthees is an associate with the company. This INSIDER contribution is based on two blog posts from the FDA Law Blog .
