One of the most common misconceptions about the dietary supplement industry is that it is unregulated.
The dietary supplement industry must follow numerous regulations, including the Dietary Supplement Health and Education Act of 1994 (DSHEA), current Good Manufacturing Practices (cGMPs), the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, and other laws. The rules apply to both dietary supplement contract manufacturers and brand owners.
If you are wondering what agency polices this, we have three words for you: “FDA supplement regulation.”
With this type of oversight—and the fact that brand owners have liability as well as manufacturers—you want to ensure your contract supplement manufacturer is compliant with industry regulations. How can you do this, though?
In this article, we’ll simplify the rules and regulations of the dietary supplement industry and how manufacturers can follow them. Knowing this important information will help you understand how to find a supplement manufacturer you can trust.
Let’s begin by exploring the rules and regulations that govern the nutraceutical industry, starting with DSHEA.
Understanding the Compliance Responsibilities of a Supplement Manufacturer
Dietary Supplement Health and Education Act of 1994 (DSHEA)
This is a statute of United States Federal legislation that defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111. DSHEA spells out regulations regarding the manufacture and sale of dietary supplements and defines a dietary supplement as “a product (other than tobacco) intended to supplement the diet that bears or contains one of more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient noted in clause (A), (B), (C), (D), or (E).”
Current Good Manufacturing Practices (cGMPs)
These regulations stipulate cGMPs for dietary supplements, requiring that proper controls are in place, so they are processed consistently to meet identity, purity, strength, and composition quality standards. cGMPs apply to all domestic and foreign companies that manufacture, package, label, or hold dietary supplements, including those involved with the activities of testing, quality control, packaging, labeling, and distributing them in the U.S. All supplement companies are required to maintain cGMPs, and to have a program in place to audit all contract manufacturing, packaging, and distribution facilities that they use, to verify compliance with cGMPs.
Food Safety Modernization Act of 2011 (FSMA)
FSMA was enacted to prevent widespread occurrences of foodborne illness. FSMA includes a requirement that companies manufacturing, processing, packing, or holding human food identify food safety hazards and implement preventive controls. This may include manufacturers of dietary supplements.
Fair Packaging and Labeling Act (FPLA)
FPLA directs the Federal Trade Commission (FTC) and the FDA to issue regulations requiring that all “consumer commodities” be labeled to disclose net contents, identity of commodity, and name and place of business of the product’s manufacturer, packer, or distributor. The Act authorizes additional regulations where necessary to prevent consumer deception (or to facilitate value comparisons) concerning descriptions of ingredients, slack fill of packages, use of “cents-off” or lower price labeling, or characterization of package sizes.
Other regulations
Other regulations applicable to the dietary supplement industry include:
- Food and Drug Administration Modernization Act of 1997 (i.e., health claims based on an authoritative statement of a scientific body of the U.S. government or the National Academy of Sciences)
- Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (i.e., protect the public from a threatened or actual terrorist attack on the U.S. food supply)
- Consumer Health Information for Better Nutrition Initiative of 2003 (i.e., provides for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation)
- Food Allergen Labeling and Consumer Protection Act of 2004 (i.e., labeling of foods and supplements that contain certain food allergens)
- Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 (i.e., adverse event reporting)
- Food Safety Modernization Act of 2011 (i.e., identify food-safety hazards and implement preventive controls)
Contract manufacturers have responsibility for each of these regulations.
How Contract Supplement Manufacturers Can Ensure Compliance
Certifications
Manufacturers often claim to follow FDA nutraceutical guidelines, operate out of quality contract manufacturing facilities, or perform cGMP contract manufacturing. However, these claims do not guarantee adherence to cGMPs. True assurance comes from GMP certification, and yet the FDA does not issue Good Manufacturing Practice certificates or seals to dietary supplement companies. Rather, when a supplement manufacturing facility is inspected by the FDA, the agency will issue its findings in an Establishment Inspection Report (EIR). The EIR may contain FDA Form 483, which highlights observed deficiencies in cGMP compliance, focusing on potential violations related to facility, equipment, processes, controls, products, employee practices, or records. Form 483 findings can be serious and need to be addressed with prompt corrective actions, or the FDA can take further measures against the non-compliant company.
If you are considering a supplement contract manufacturer, you will want to ask to see any Form 483s resulting from the company’s FDA inspections.
Although the FDA does not issue GMP certificates, independent certifications exist. A GMP-certified facility has been audited for cGMPs by a credible third-party agency, ensuring compliance with industry standards. Among the best of the GMP certifying authorities are NSF and USP. Providers of supplement contract manufacturing services can go beyond GMP by being Certified for Sport by NSF, Informed Choice, and others. Sport certification provides extra assurance about supplement safety for athletes, coaches, dieticians, and consumers. In addition, manufacturers can be certified to make Kosher, Halal, non-GMO, clean-label, organic products, to meet various consumer preferences.
Another consideration is the rare but globally recognized standard in the food and supplement industry known as FSSC 22000 certification for food safety. All these certifications can potentially give your products a competitive edge. These are the types of certifications you should look for in a contract manufacturer.
Product Safety
Another important consideration is safety. A contract manufacturer must take all the necessary steps to ensure the safety of the products they manufacture. These steps should include testing for identity and potency, microbiological compliance, and heavy metal compliance. In addition, each tablet press, encapsulation machine, and powder filling line should include rare earth magnet metal detectors as an important safety component.
Audits and Inspections
Manufacturers should stay in good standing with regulatory agencies worldwide and maintain open communication. In addition to their scheduled routine FDA inspections and annual cGMP audits by NSF, USP, and others, manufacturers may undergo various third-party audits and inspections throughout the year.
Ingredient Sourcing & Product Testing
Although ingredient suppliers should and will provide a certificate of analysis (COA) for each lot of each raw material, the contract manufacturer should not rely wholly on the vendor’s COA (trust but verify). That means that once the raw materials arrive at the contract manufacturing facility, they should be quarantined and tested before they are released into inventory. As with finished product testing, ingredient testing includes identity and potency, microbiological compliance, and heavy metal compliance.
Identity and Potency
To test for identity and potency, there must be an established methodology for testing the raw material ingredient. That methodology may exist in the U.S. Pharmacopeia, or by provided by some other credible source. Not only must that methodology be followed but a standard must be purchased if the contract manufacturer doesn’t already have the standard. If you didn’t already know, a standard is an authenticated and validated sample of the raw material ingredient that the CM’s laboratory will use for comparison purposes. The raw material will be tested against the standard using appropriate laboratory equipment to see if it matches.
Microbiological Testing
Next, the raw material must be tested for microbiological compliance to verify that it does not contain dangerous levels of microorganisms such as E. coli. Special equipment in a separate microbiological laboratory will be required for this purpose. Since all contract supplement manufacturers do not always have an in-house microbiological lab, this may mean that the raw material will have to be sent to a third-party lab for micro-testing.
Heavy Metal Testing:
Finally, heavy metal testing for lead, mercury, cadmium, and arsenic must also be conducted. Not only is this required and the right thing to do, but for those who intend to market their products in California, even more stringent heavy metal limits may apply.
These are the types of product testing procedures that you’ll want to confirm take place when choosing a contract manufacturer. Vitaquest routinely conducts all the testing procedures shared in this article.
Are You Looking for a GMP-certified Supplement Manufacturer?
While there are certainly other GMP supplement manufacturers that are third-party certified, few, if any, offer the full range of certifications and multiple decades of experience that Vitaquest does.
Vitaquest is a trusted partner for brand owners looking for best-in-class dietary supplement manufacturing services. We currently create and produce 4,000-plus custom formulas for over 500 brands worldwide. Our FDA-registered facility holds NSF and USP GMP certification, is NSF Certified for Sport, offers Kosher, Halal, Non-GMO Project, Clean Label Project, and certified organic products, and holds the FSSC 22000 certification for food safety.
To learn more about how we can help you deliver what’s next in the nutraceuticals industry, call 800-526-9095 to speak with one of our sales executives or request a competitive nutraceutical manufacturing price quote.
Frequently Asked Questions
Q: What is the role of a contract manufacturer?
The role of a good contract manufacturer is to produce quality dietary supplements for brand owners, adhering to cGMPs as required as part of DSHEA and other applicable laws and regulations
Q: What is cGMP in manufacturing?
cGMP refers to Current Good Manufacturing Practices. These regulations stipulate cGMPs for dietary supplements, requiring that proper controls are in place for dietary supplements so that they are processed consistently to meet identity, purity, strength, and composition quality standards.
Q: What type of responsibility does a brand owner accept concerning the contract manufacturer?
Per DSHEA, brand owners have many of the same cGMP responsibilities as contract manufacturers. That’s why you must ensure your manufacturer complies with industry regulations.
Q: What tests are conducted on ingredients and finished dietary supplements?
Ideally, testing should include identity and potency, microbiological compliance, and heavy metal compliance.
