You hear comments in mainstream media like “the dietary supplement industry is not regulated” all the time, yet these comments and claims couldn’t be further from the truth! Currently, there are dozens of laws and regulations in place to oversee the dietary supplement industry. Among those regulations are GMPs. Understanding what GMPs are, exactly, can prove confusing for industry newcomers and brand owners who may be starting a supplement company for the first time. In an effort to help, we’ve answered the five most common questions asked by brand owners about GMPs.
The 5 Most Common GMP Questions Asked by Individuals Starting a Supplement Company
Question #1: What does GMP stand for and who enforces them?
The U.S. Food and Drug Administration (FDA) issued and enforce a final rule establishing regulations requiring good manufacturing practices (GMPs) for dietary supplements. The GMP final rule requires that proper controls are in place for dietary supplements so that every step of the production process – from sourcing materials to storage and distribution – meets the established quality standards. These GMP requirements help ensure that dietary supplements consistently meet specifications for purity, strength, and composition.
Question #2: How does a contract manufacturer become GMP certified?
While the FDA requires that manufacturers adhere to the GMP regulations, it does not require manufacturers to be GMP certified. The manufacturer must willingly open up their manufacturing facility, records, and practices to a comprehensive audit by a third-party organization. After passing the audit, the manufacturer can gain their GMP certification.
When it comes to third-party organizations capable of granting a certification, NSF is arguably the most well-known. During an audit, a team auditors will arrive at the manufacturing facility, and over a period of several days they’ll inspect and audit all of the procedures, documents, and employee qualifications relating to dietary supplement manufacturing. Including factors like:
- The design and construction of physical plants
- Maintenance and cleaning of the plant and equipment
- Proper manufacturing procedures
- Quality control procedures
- Testing of materials and products
- Proper handling of consumer complaints
- Maintaining appropriate written procedures and records
Once they have their NSF GMP certification, a manufacturer has to undergo regular follow-up audits several times a year if they’d like to maintain that certification.
Question #3: Can I put GMP logos on my product label and packaging?
An NSF GMP Certification is specifically for the manufacturing facility, and the associated logo cannot be used on product labeling. However, NSF offers an additional certification service to companies who wish to use a special NSF logo on the label to demonstrate that individual dietary supplements have been tested and verified for their contents. Dietary supplement companies can choose to include a generic logo on their packing (see example) to let customers know that the vitamins or supplements they’ve purchased have been manufactured according to GMP standards.
Question #4: Where can I find a list of companies that have committed GMP violations?
Since the FDA enforces GMP regulations, anyone can search the FDA’s website to determine if a company/manufacturer has ever been in violation of GMP regulations. Arguably, what’s even more important than whether or not a company/manufacturer has ever had any violations is how they responded to their citations. Did they ignore the issue or did they take the necessary measures to fix the problem in a timely manner?
Question #5: What else do I need to know about GMP Certifications before launching my product line?
First and foremost, make sure the company you choose to work with either completes its vitamin and supplement manufacturing services in a GMP Certified facility that has been audited by a third party organization such as NSF. If they aren’t recognized as a GMP Certified manufacturer, do your due diligence and confirm that they manufacture products according to mandated GMP guidelines. That’s 95% of what you need to know about GMP certifications. The other 5% is to:
- Maintain records of all documentation you receive from your manufacturer
- Decide if and how you may want to use some type of logo on your label that references GMPs (see the prior response to “Can I put GMP logos on my product label and packaging?”
- Feel free to ask your manufacturer any questions you have about GMP (if they’re not willing to answer, find another manufacturer).
There’s a reason why people say “you never have a second chance to make a first impression.” The same goes for a customer’s first impressions about your product quality. Making sure that you have your products made in a cGMP contract manufacturing facility is a simple way to make sure that your products stand out among the rest.