Many Americans will be gathering around the table for a Thanksgiving Day feast on November 27th. Special family recipes will be pulled out; fresh produce, dairy, and meat or poultry will be carefully chosen; and particular brands of key ingredients will be sought out to ensure delicious results. Those special preparations are the every day responsibilities of dietary supplement ingredient suppliers, manufacturers, and brand owners.
The quality responsibilities of those various players in offering a dietary supplement for sale in the U.S. are codified in regulations at 21 CFR 111 and 21 CFR 117. However, I have found that some brand owners don’t understand their role in assuring that their products are manufactured in compliance with the regulations. FDA has issued warning letters to brand owners (for example, here and here) that did not have their own quality program to verify that their contract manufacturer was complying with the required Good Manufacturing Practices (GMPs).
Which regulations apply even if you’re not the manufacturer?
Simply put, if your company is name is on the product, you have GMP responsibilities. FDA has published regulations and guidance as noted above. Dietary supplement trade magazines frequently publish articles on quality issues regarding dietary supplements. This blog has barely touched on the topic because it is deep and broad and hard to cover in a few paragraphs. In the simplest terms, dietary supplement brand owners (aka private labelers or own label distributors) have the following GMP responsibilities:
- Set specifications for the ingredients, packaging, labeling, and finished product.
- The specifications for the ingredients and finished products must detail the required identity, purity, strength, and composition to ensure the product is manufactured as intended and meets label claims.
- Review and verify that the manufacturer met those specifications for each batch of product. Verification typically requires some lab testing.
- Have a system in place to receive complaints or reports of adverse effects.
- Review any complaints or adverse effects and the manufacturing documentation for the reported product. Note that serious adverse effects must be reported to FDA within 15 business days of receiving the report.
Unfortunately, each item on the list above leads to several specific regulations. One of the best summaries of GMP requirements and who they pertain to that I’ve come across was published in 2016 by Bruce Elsner. The summary is actually a list of required documentation and who must have it, but if followed, will help dietary supplement distributors understand their GMP responsibilities.
The paragraphs above offer only highlights of the GMPs required to ensure that dietary supplement products marketed in the U.S. are safe and perform as intended by the brand owner. Your brand deserves the care and attention to detail you would put into preparation of a holiday meal for your friends and family since all your customers are somebody’s friends and family.
As always, I hope you find these occasional posts helpful. Contact us with questions and comments.
Oh, and Happy Thanksgiving!
