Allegation of Wrong Identity for Dietary Supplements Means Increased FDA Scrutiny for the Whole Industry
The New York attorney general’s office is alleging that the store brand dietary supplements sold by four major retailers are misbranded and adulterated. New York asserts that the products did not contain the declared dietary ingredients, in many cases only contained fillers, and in a few cases, contained non-disclosed allergens like soybeans or peanuts. In response, New York demanded that the companies remove the products from shelves and hand over their product verification procedures.
Dietary supplement manufacturers are subject to FDA’s requirements put forth in current Good Manufacturing Practices (cGMPs) for Dietary Supplements. This includes requirements that manufacturers verify, through testing or certification, the identity of all their ingredients and components. Though these retailers are not the manufacturers for their store-brand products, they are the declared distributors (that is, they are identified on the label with the qualifier “Distributed by”). This means that they are held ultimately responsible for cGMP compliance of the product and its manufacturing, including verifying the identity of the product. Among the challenges faced by distributors is the lack of validated methodology to test for many herbal supplement ingredients. This argument, however, has fallen on deaf ears when presented to FDA.
Indeed, FDA has increasingly focused on dietary supplement cGMP enforcement in recent years. This highly-publicized NY allegation will likely increase FDA’s scrutiny significantly. It is not uncommon for New York to press an issue under its state authority that the attorney general believes the federal government is leaving unattended. As a result, we anticipate the dietary supplement industry will soon see more numerous and more aggressive FDA inspections focusing on cGMP compliance, especially as they relate to product identity.
These inspections will not only focus on the firms that actually make the product, but also focus on distributors that rely on contract manufacturers. Given this likely increased scrutiny, firms should be reviewing their cGMPs, especially as they relate to product identity, in order to avoid 483s, Warning Letters, or worse, as in the cases in New York.