The U. S. Food & Drug Administration (FDA) regulates the manufacturing process of food, drug, cosmetic, and dietary supplements. The FDA has established current Good Manufacturing Practices (GMP) for manufacturing, packaging, holding, and labeling dietary supplements. These practices can be found in the Code of Federal Regulations Title 21 part 111 often referred to as 21 CFR.
Like all pharmaceutical manufacturers, supplement manufacturers must be registered with the FDA to operate. However, FDA does not administer nor require a dietary supplement manufacturer certification program. The FDA simply enforces GMP regulations.
Private Third-Party GMP Certification Programs
Since there is no FDA GMP certification or accreditation program to acknowledge GMP compliance, private third-party companies like NSF International, Underwriters Laboratory (UL), Consumer Lab, and U.S.
Pharmacopeia (USP) have developed certification options for supplement manufactures to obtain.
These private companies charge the supplement manufacturer to either:
1- Audit their manufacturing facilities looking for conformity to GMP requirements.
2- Test supplement ingredients and manufactured product for product quality. These analyses can include testing for banned ingredients and determining the supplement meets label claims.
A facility audit from one of these private companies ranges from $13,000-$15,000. Verifying supplement ingredients cost somewhere between $300-$15,000 per a product. These third-party certification costs will naturally be passed onto the consumer in escalated product pricing. But remember these costs do not have to be part of the supplement since the FDA does not require third-party GMP certification just GMP compliance.
FDA GMP Requirements
The FDA enforces GMP practices covered in 21 CFR 111 to assure quality standards are met in proper design, monitoring, and control of pharmaceutical
production by regulating the supplement manufacturer’s physical plant, equipment, personnel training, production processes and quality control systems, packaging and labeling, holding and distribution systems, supplement returns, and documentation and record-keeping.
Testing is a major part of the FDA GMP quality system and includes identity testing of incoming materials and micro testing to rule out undesirable organisms. Additional testing may be required depending upon the substances in question. These regulations assure consumers of the identity, strength, quality, and purity of the produced dietary supplements and drug products.
FDA Audits Dietary Supplement Manufacturers
The FDA randomly audits supplement manufacturers and targets any manufacturer with filed complaints. When auditing, the FDA is looking for facilities in good condition with properly maintained and calibrated equipment, fully trained and qualified employees, reliable and reproducible processes, and clear and complete documentation.
Faulty Third-Party GMP Certification
Recently, the value of a supplement manufacturer obtaining private GMP third-party certification to show they meet GMP guidelines has been brought into further question. The Natural Products Insider, a leading information source for dietary supplement manufactures, highlights in their Spring 2020 news section the FDA ordering a massive recall of a New York dietary supplement manufacturer’s products due to non-GMP compliance.
The private company UL withdrew their GMP certification of this manufacturer just eight days prior to the Department of Justice announcing an injunction. In the National Products Insider article, Kenneth Colt, business manager of NSF International says, “It’s important to remember that GMP audits are a snapshot of a moment in time.”
Additional Certification Options for Supplement Manufacturers
Instead of a GMP certification by a private third-party, a supplement manufacturer could choose to obtain organic, kosher, and/or halal certifications. These certifications are more cost effective to obtain and demonstrate to consumers the manufacturer’s adherence to good practices. These extra
certifications require precise equipment cleaning to avoid contamination, detailed documentation of ingredients identity and purity, and additional quality testing.
The Reality of GMP Certification
GMP certification by a private third-party company is expensive. And it might not even mean the company is GMP compliant with the FDA. However, a supplement can be manufactured that meets all FDA GMP guidelines to give consumers a high-quality supplement at a fair price.
Sources
21 CFR 111. April 1, 2019. Code of Federal Regulations Title 21. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=111
Loria, Kevin. 2019. “How to Choose Supplements Wisely.” Consumer Reports. https://www.consumerreports.org/supplements/how-to-choose-supplements-wisely/
Dinato, Nichole. 2019. “What is a GMP Certification?” Career Trend. https://careertrend.com/facts-7166463-GMP-certification-.html
“Current Good Manufacturing Practices (GMP) Regulations” FDA. 2018. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-GMP-regulations
Myers, Steve and Long, Josh. Spring 2020. “Massive Supplements Recall Raises Questions About GMP Certifications.” National Products Insider. https://www.naturalproductsinsider.com/regulatory/supplement-maker-subject-massive-recall-was-gmp-certified
“Facts About the Current Good Manufacturing Practices.” FDA. 2018. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about