The current Good Manufacturing Practice (cGMP) regulations for dietary supplements were issued by the FDA in June 2007, and implemented from 2008 to 2010—depending on the size of the company, and small companies having three years to comply. For rigorous FDA manufacturing facility inspections from analytical testing, through all procedures, training, paperwork, batch records, and the final label review, the regulation was designed to bring sweeping changes to the dietary supplement industry.
Within the cGMPs, manufacturers are charged with validating the identity, purity, strength, and composition of dietary ingredients at the very beginning by utilizing methods that are “appropriate for the tests performed and the materials being tested.”
Dietary supplements have long been a target of economic adulteration, prompted by high costs associated with purified extracts and quality materials. Industry observers also readily acknowledge that analytical methods are sometimes manipulated by organizations seeking to claim they use the highest-quality materials.
That said, the FDA defines GMP regulations as “the minimum current requirements for methods used in, the facilities or controls used for, the manufacture, processing, packing, or holding of a dietary supplement to assure its safety, identity, strength, quality, and purity.”
The implementation of these regulations has been a long process, beginning with the Dietary Supplement Health and Education Act of 1994 (DSHEA). Understanding all aspects of DSHEA can be daunting in and of itself. Many manufacturers have questions surrounding the regulations – and rightfully so. They are looking for guidance on how to effectively train internally to accurately and appropriately formulate products that ultimately end up on store shelves. It is vital to operate within the DSHEA framework in an effort to maintain a solid reputation with the FDA. You don’t want to be that manufacturer that is exposed for noncompliance. This would obviously be catastrophic for any manufacturer. Two great resources for details on how to be DSHEA compliant can be found at the Council for Responsible Nutrition and the Natural Products Association websites.
But whatever resources are used, the onus is always on the manufacturer to validate the identity, purity, strength, and composition of all ingredients. According to the FDA, the goal of the GMP regulations is to “ensure the quality of dietary supplements so that consumers can be confident the products they purchase contain what is on the label.”
Thankfully, these regulations also include manufacturing controls to preclude unsafe levels of contaminants such as pesticides, bacteria, lead and other heavy metals. The GMP regulations do not address efficacy, only manufacturing.
Although the dietary supplement manufacturing requirements are not as rigorous as the pharmaceutical GMPs, much of the wording is similar. Manufacturers are required to keep detailed records documenting all standard operating procedures (SOPs) and they must have a formal process for review and updating SOPs. In addition, training records for all employees must be kept current and a master manufacturing record for all formulas must be maintained. This regulation requires extensive record keeping, and requires access to these records by the FDA.
At the beginning of the process, identity testing must be performed on every dietary ingredient used in each batch. This can be performed by the manufacturer or by the supplier, but the manufacturer is responsible for verifying the reliability of the supplier. Interestingly, raw material suppliers were not included in the rule because the FDA is putting the responsibility on the manufacturer. However, as a way to deflect some of the costs, manufacturers sometimes require some of their suppliers to meet certain of the regulations—and to be “pre-certified.”
Furthermore, analytical testing for dietary supplements can be complex and cumbersome. This has prompted a growing number of manufacturers to outsource this all-important function to contract laboratories. However, making an informed decision about an outside testing provider requires a significant investment in time and energy. Manufacturers must do their due diligence.
In today’s social media world where hard-earned reputations can be destroyed in a matter of minutes, the company you choose as your testing provider says a lot about your commitment to safety and quality. Failure to select a lab that delivers consistent and reliable services can undermine your reputation and ultimately be catastrophic for your business.
In the end, manufacturers must be smart and tread carefully when it comes to validating the identity, purity, strength, and composition of the compounds used in finished products that end up on store shelves. Our industry has evolved into one of increased oversight and regulation. The cGMP learning curve and full compliance may be a headache, but it is necessary if you want to avoid the wrath of the FDA. That is a headache you don’t want—which could well be accompanied by a Warning Letter from the Agency, detailing all of your GMP violations, a Letter posted on the FDA’s website for the entire industry and all consumers to see!
Mark Becker is the EVP, Sales and Marketing for Allied BioNutrition Corp., a global biotechnology leader, based in Los Angeles, CA. He has worked as a natural products sales and marketing executive for 20 years. Mark has written more than 300 articles and has hosted or been a guest on more than 500 radio shows. He obtained a bachelor’s in journalism from Long Beach State University and did his Master’s work in communications at Cal State Fullerton. For more than 30 years he has participated in numerous endurance events, including more than 150 triathlons of Olympic distance or longer, 103 marathons and numerous other events including ultramarathons and rough water swims from Alcatraz to the mainland. He has relied on a comprehensive dietary supplement and homeopathic regimen to support his athletic, professional and personal endeavors. Follow Allied BioNutrition on Facebook at https://www.facebook.com/AlliedBioNutrition11/?fref=ts. Follow Mark on Twitter at @AlliedMbecker. For more information, access www.AlliedBioNutrition.com.
DISCLAIMER: THE MATERIAL ABOVE AND ON THIS PAGE IS FOR CONSUMER INFORMATIONAL PURPOSES ONLY. NOTHING ON THIS PAGE IS INTENDED AS, OR SHOULD BE CONSTRUED AS, LEGAL ADVICE. SUPPLEMENT COMPANIES SHOULD CONSULT WITH THEIR OWN FDA LAW REGULATORY ATTORNEYS FOR SPECIFIC LEGAL ADVICE ABOUT DSHEA AND AS TO GMP COMPLIANCE.