It is very important for dietary supplement manufacturers to understand FDA regulations and comply with them. The Current Good Manufacturing Practices (cGMPs) are the FDA minimum requirements that a manufacturer must meet to produce a dietary supplement. The cGMPs are found in 21 CFR Part 111. These regulations were implemented to protect you, the consumer, so that you can have some assurance that the product you are taking has actually been manufactured in a consistent manner and that it has been properly labeled. These regulations also give you some peace of mind that the product does not contain any undeclared contaminants or adulterants.
So, what are cGMPs when it comes to dietary supplements?
The FDA’s regulations under 21 CFR Part 111 cover the entire life cycle of a supplement, from manufacture and packaging to labeling, holding, and distribution. If you’re looking for the full regulatory text, it’s available here: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111. The great goal is the consistent, controlled production of a supplement; its accurate labeling; and the absence, in the supplement, of any harmful contaminants or improper ingredients.
A robust quality control program is one of the cornerstones of cGMP compliance. It is not enough for a manufacturer to have quality control. The manufacturer must develop written procedures for overseeing quality at every stage of production and must follow those procedures. Quality control begins with the testing of raw ingredients, which are tested for identity, potency, and purity. The quality control program requires that detailed batch records be kept. The program also requires that validated techniques are used in the production process to guarantee that the product turns out uniform. The FDA outlines the quality standards in more detail here: https://www.fda.gov/files/drugs/published/Overview-of-Quality-System-Regulation.pdf.
Testing—of both individual ingredients and finished products—is equally critical. Every component must be verified to ensure it meets specifications for identity, strength, and purity. Once the product is complete, it must be evaluated again to ensure it aligns with what the label says and with safety standards. Although not mandatory, many manufacturers use third-party labs to help with testing.
More information on testing and labeling can be found on the FDA website.
cGMP compliance necessitates not only the cleanliness and control of conditions within a facility, but also the training of all personnel in the facility—from top to bottom. Cleanliness, control, pest management, and personnel training are, in effect, the four corners of a facility effectively registering cGMP compliance with the FDA. For a more detailed and comprehensive look at the cleanliness, control, pest management, and training of individuals in a cGMP-compliant facility, the FDA has a 74-page document that is a must-read for anyone responsible for (and even those who are just interested in) the management of a FDA-regulated facility.
The FDA’s oversight depends greatly on recordkeeping. It expects firms to keep detailed records of their production and all related testing for at least a year past the expiration date of a product. It expects these records to be well-organized and immediately accessible when the FDA comes to inspect. What follows isn’t the exact wording of the FDA’s recordkeeping guidance. But it summarizes what the guidance mostly says and gives you the gist of it—what the FDA expects, really. And the FDA has a fairly good reason for what it expects.
Not following regulations isn’t just a risk for regulatory agencies—it can very rapidly become a business crisis. Drug and biological product manufacturers that do not comply with cGMP run the risk of receiving FDA warning letters, having to recall products, or even facing civil penalties and lawsuits. For some examples of recent enforcement actions, you can visit: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters.
To stay ahead of regulatory hurdles, it’s wise for manufacturers to adopt a few recommended practices. They include:
- Conducting regular internal audits.
- Engaging third-party labs for ingredient verification.
- Providing comprehensive training to all staff.
- Documenting every step of the production process.
Keeping closely aligned with—and well informed about—FDA guidance on manufacturing, testing, and labeling helps reduce the risk of enforcement actions, too. The agency has a wealth of resources on its website, which can be accessed at the URL given above.
Still following FDA cGMP regulations isn’t just a demand of the law; it’s a requirement taken on by many companies in the United States. Why? Because it’s a pathway to product quality and consumer safety. My law office, Cohen Healthcare Law Group, helps companies with a variety of legal needs related to FDA compliance, and we do it with a clear set of goals in mind: to empower our clients, to help them achieve the American dream of stability, security, and success. Here’s a brief overview of what we can do.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
Contact Us
