If You Think the FDA’s cGMPs Don’t Apply to You, Think Again!

April 30, 2012 By

By Heather Van Blarcom
General Counsel & Senior Regulatory Specialist – USA

If your name is on the label of a dietary supplement product that you market and distribute, you are ultimately responsible for complying with the requirements related to manufacturing operations, even though you have hired a contract manufacturer with a Good Manufacturing Practices (GMP) certification. [72 FedReg.34752,34790(June 25, 2007)]

Pursuant to the FDA, you, as the marketer and distributer of the product, have the ultimate responsibility of ensuring that your products are manufactured in compliance with the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Many companies assume that because their products are manufactured at a facility claiming to be CGMP compliant, even those with a certificate of compliance from a third party, they have fulfilled all of their obligations under the law. Unfortunately, that assumption is wrong and creates a serious risk for the uninformed. Using a CGMP certified manufacturing facility does not absolve you of the responsibility of CGMP compliance. In the FDA’s eyes, you are deemed to be a manufacturer of every dietary supplement product that is manufactured and distributed under your name.

The FDA has been making its rounds to not only manufactures of dietary supplements, but also to companies that are “own-label” dietary supplement distributors, meaning you sell products with your own name on the label. Failure to comply with the CGMP will cause your products to be construed as adulterated by the FDA. To minimize this risk be sure YOU, and not just your manufacturer, have:

  1. Finished product specifications for each component used in the manufacture of your products;[1]
  2. Specifications for your labels; [2]
  3. Written procedures designed to allow your Quality Control team to determine whether your packaged and labeled products conform to established specifications and whether you should approve and release the products for distribution;[3]
  4. Written procedures for holding and distributing products to ensure that your dietary supplements , as well as their components, are stored under appropriate conditions to maintain quality and prevent mix-ups, contamination, or deterioration;[4]
  5. Maintained samples of each packaged and labeled lot that you distribute for one year past expiration or two years from the date of its last distribution;[5]
  6. Written policies for handling product returns and product complaints.[6]

Following these steps will help to keep you from being caught off guard when the FDA asks you, and not your contract manufacturer, for proof that the products you market and distribute are manufactured in compliance with CGMP.

[1] 21 CFR 111.70(b)
[2] 21 CFR 111.70(d)
[3] 21 CFR 111.103, 21 CFR 111.140(b)(1), 21 CFR 111.105, and 21 CFR 111.120(b)
[4] 21 CFR 111.455 (a) and 21 CFR 111.140(c)
[5] 21 CFR 111.83(a), 21 CFR 111.83(b)
[6] 21 CFR 111.503 and 21 CFR 111.560(a)(1)

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com