SupplySide West: FDA update on NDIs, GMPs and claims

Hilmas opened with some statistics on NDIs, noting most (60%) are botanicals, with the numerous other ingredient types each comprising a single-digit stake. He also reported 56% of NDI notifications result in an "inadequate" letter, meaning the notification lacked sufficient data to show safety. Only 19% of submissions have received an acknowledgment letter, which means FDA has no immediate objection. The agency has 75 days to review the NDI notification before the product can be marketed, but Hilmas reported the agency is now averaging 48 days turnaround and is making "a conscious effort to decrease that."

Hilmas stressed the importance of communicating with the agency, noting companies who have submitted NDIs and also had a teleconference (Tcon) with FDA appeared more likely to receive an acknowledgment letterover a five-year period 96.7% of companies receiving such a letter had a Tcon with FDA; in fact, only two companies got such a letter without having a Tcon.

It appears companies also tend to accept initial defeat. Hilmas noted 72.8% of those receiving inadequate letters did not resubmit a notification; yet almost half of the 27.2% of companies that did  resubmit ended up getting an acknowledgment letter.

On claims, Hilmas reminded a disease claim can be either explicit ("this product treats  X disease") or implicit (may improve a symptom that is commonly associated with a disease.)  His advice is: " The verb in a claim matters less than the stuff after it," meaning how you qualify it is key. He advised companies to consider the context and limit the scope to non-disease states.

Pope focused on GMPs, specifically responsibilities under the regulation. She said the growth in private or own label product lines is challenging  the understanding of responsibilities under GMPs. While she acknowledged the increasing number of different business models is a challenge, "Part 111 makes it clear that there has to be a responsible party for compliance with GMPs, where more than on party is involved in the manufacture, packaging, labeling and holding of dietary supplements."

Pope reminded distributors contracting with a manufacturer for producing supplements  that under the regulation they have an obligation to know about the activities performed so that it can decide if the packaging and labeling conform to specifications before release to distribution.

Unfortunately for the many companies involved in complex business partnerships, Pope said the preamble states that it is not practical to list all possible contractual relationships or all businesses or practices that may be subject to the requirements of this final rule.

For own label products, both the product owners and the contractors must comply with GMPs. Pope advised virtual firms, while not responsible for direct oversight of manufacturing, are subject to inspections and should be prepared for them .

In the end, Pope suggested companies determine who in the partnership will set specifications for both finished product and raw materials, including master manufacturing records, batch records and testing data. Also important is figuring out who will handle adverse event reporting, product complaints and qualification programs. Supply/business and quality/technical agreements are great tools to help define responsibilities in contracted partnerships.  

The SupplySide West 2013 Education program was sponsored by BASF. The FDA session and the rest of education program presentations are featured on the SupplySide West 2013 Education Program DVDs.