Cheryl Luther, General Manager, Dietary Supplement Programs, NSF International11.01.16
Rob Ninkovich learned a costly lesson in September. The New England Patriots defensive end was suspended for four games after testing positive for a banned substance—one he wasn’t even aware he had taken.
Mr. Ninkovich told ESPN, “Any supplement I’ve ever used was bought at a store. I was unaware something I bought had a substance in it that would give me a positive test because it wasn’t listed [as an ingredient on the label].”
Most people in the dietary supplement industry—and many professional and elite athletes—know that checking the label isn’t always enough. In the last 18 months, the U.S. Department of Justice pursued civil and criminal cases against more than 100 dietary supplement companies for supplements containing unlisted ingredients or making unsupported claims. The U.S. FDA has seized products and shut down several manufacturers for violations of 21 CFR Part 111 and courts are handing down hefty fines and contempt sentences.
Additionally, recent research published in Drug Testing and Analysis identified oxilofrine, labeled as deriving from bitter orange or acacia, in 14 supplements. Other investigations have found DMAA falsely labeled as an extract of geranium, DEPEA marketed as an extract of dendrobium orchid and DMBA labeled as an extract of pouchong tea. These banned ingredients can endanger health and be particularly harmful to athletes who may be suspended for unknowingly taking products that contain banned substances masquerading as legitimate products. As the Patriots’ Mr. Ninkovich discovered, you can’t always trust what’s on the label.
As this high-profile case illustrates, the actions of a few bad or careless manufacturers can irrevocably harm brand reputation and reflect negatively on the entire supplement industry.
Fortunately, reputable companies can seize this opportunity to showcase their products’ safety, verify label claims and differentiate themselves in the marketplace. Independent, third-party certification of dietary and sports supplements and ingredients helps ensure safer, quality products.
Three Levels of Compliance & Certification
So how do reputable manufacturers demonstrate the quality of their products and verify the accuracy of label claims? Independent, third-party organizations like NSF International currently certify to three levels of compliance and certification standards.
Regulatory Compliance & GMPs
First, supplement companies are required to ensure their products are not contaminated, mislabeled or harmful, and comply with regulatory standards such as 21 CFR Part 111, Good Manufacturing Practices (GMP). Testing and certification ensures ingredients meet these requirements for quality and safety, provides documented evidence of ingredients and test results, and verifies label claims.
GMP guidelines require processes and documentation to assure a product has the identity, strength, composition, quality and purity that appear on its label. GMP guidelines apply to dietary supplement, ingredient and raw material manufacturers and to distribution, warehousing and packaging companies. GMP regulations also require identification of all raw ingredients.
Verifying GMPs involves assessing the physical plant and grounds, personnel, equipment, production and process control systems, holding and distribution processes, recordkeeping, and procedures for handling recalls, product returns and product complaints.
Certification to ANSI for Dietary Supplements
Next, supplement manufacturers can work toward dietary supplement certification. In addition to passing twice-annual GMP audits, certification requires products to be tested to verify compliance with NSF/ANSI 173: Dietary Supplements, the official American National Standard for dietary supplement products. This includes:
Certification to NSF/ANSI 173: Dietary Supplements provides a means to source safer products, raw materials and ingredients. Regardless of where ingredients are sourced, proper testing and qualification of suppliers is paramount to maintaining control over the supply chain and ensuring the quality and safety of finished products.
Sports Supplement & Ingredient Testing
Finally, supplement manufacturers can take an extra step and work toward independent certification for safer use by athletes. For example, the NSF Certified for Sport program builds on the NSF/ANSI 173: Dietary Supplements standard by screening for athletic banned substances. This rigorous certification program was developed with regulatory, sports industry and consumer groups to help athletes and consumers choose supplements that do not contain banned substances.
Because each product is unique, certification involves customized test methods relevant to the particular type of supplement. For example, ingredients known to contain aristolochic acid are assayed for it, botanicals are screened for pesticides, and glycerin products are tested for diethylene glycol.
Sports supplements are tested on a lot-by-lot basis for more than 245 athletic banned substances from the World Anti-Doping Agency (WADA), NSF Annex B, NFL and MLB prohibited substance lists. Testing covers various pharmacological activity classes, including anabolic steroids (e.g., testosterone and stanozolol), stimulants (e.g., amphetamine and DMAA), diuretics (e.g., chlorothiazide and bumetanide), beta agonists (e.g., albuterol and salmeterol), beta-blockers (e.g., atenolol and metoprolol), narcotics (e.g., morphine) and cannabinoids (e.g., THC), hormones and masking agents. This list is monitored and updated as new substances are discovered or banned. This is why the NSF Certified for Sport program is used by the NFL, NHL, MLB, PGA, LPGA, Canadian Centre for Ethics in Sport (CCES) and the New York City Police Department.
Increased Demand for Quality
The dietary supplements industry is responsible for ensuring product safety. More and more athletes are looking for certified products, and consumers are increasingly savvy, demanding transparency and trust. Being able to prove that what is on the label is actually what’s in the product is beneficial for producers, suppliers, retailers and consumers.
Testing and certification increase product quality and reduce the risk of adverse events caused by unidentified ingredients, of litigation and of regulatory action. Consumers and athletes can trust NSF/ANSI 173 and NSF Certified for Sport certification labels when purchasing supplements. They can be confident that consuming certified products will not result in accidental doping or adverse health effects.
Cheryl Luther, DC, is general manager of NSF International’s Dietary Supplements Program. She has extensive experience in physiotherapy and athletic performance as a sports practitioner, amateur and professional athlete, and coach. As a Certified Chiropractic Sports Physician (CCSP), she consults with athletes in the NBA, NFL and NHL, as well as U.S. Olympians and Para-Olympians.
Mr. Ninkovich told ESPN, “Any supplement I’ve ever used was bought at a store. I was unaware something I bought had a substance in it that would give me a positive test because it wasn’t listed [as an ingredient on the label].”
Most people in the dietary supplement industry—and many professional and elite athletes—know that checking the label isn’t always enough. In the last 18 months, the U.S. Department of Justice pursued civil and criminal cases against more than 100 dietary supplement companies for supplements containing unlisted ingredients or making unsupported claims. The U.S. FDA has seized products and shut down several manufacturers for violations of 21 CFR Part 111 and courts are handing down hefty fines and contempt sentences.
Additionally, recent research published in Drug Testing and Analysis identified oxilofrine, labeled as deriving from bitter orange or acacia, in 14 supplements. Other investigations have found DMAA falsely labeled as an extract of geranium, DEPEA marketed as an extract of dendrobium orchid and DMBA labeled as an extract of pouchong tea. These banned ingredients can endanger health and be particularly harmful to athletes who may be suspended for unknowingly taking products that contain banned substances masquerading as legitimate products. As the Patriots’ Mr. Ninkovich discovered, you can’t always trust what’s on the label.
As this high-profile case illustrates, the actions of a few bad or careless manufacturers can irrevocably harm brand reputation and reflect negatively on the entire supplement industry.
Fortunately, reputable companies can seize this opportunity to showcase their products’ safety, verify label claims and differentiate themselves in the marketplace. Independent, third-party certification of dietary and sports supplements and ingredients helps ensure safer, quality products.
Three Levels of Compliance & Certification
So how do reputable manufacturers demonstrate the quality of their products and verify the accuracy of label claims? Independent, third-party organizations like NSF International currently certify to three levels of compliance and certification standards.
- First, supplement manufacturers must demonstrate regulatory compliance and adherence to Good Manufacturing Practices (GMPs).
- Next, supplement manufacturers can certify their products to NSF/ANSI 173: Dietary Supplements, the official American National Standard for dietary supplement products.
- Finally, the highest level of independent, third-party certification requires testing on a lot-by-lot basis for more than 245 athletic banned substances. The NSF Certified for Sport program is an example of this most rigorous level of certification.
Regulatory Compliance & GMPs
First, supplement companies are required to ensure their products are not contaminated, mislabeled or harmful, and comply with regulatory standards such as 21 CFR Part 111, Good Manufacturing Practices (GMP). Testing and certification ensures ingredients meet these requirements for quality and safety, provides documented evidence of ingredients and test results, and verifies label claims.
GMP guidelines require processes and documentation to assure a product has the identity, strength, composition, quality and purity that appear on its label. GMP guidelines apply to dietary supplement, ingredient and raw material manufacturers and to distribution, warehousing and packaging companies. GMP regulations also require identification of all raw ingredients.
Verifying GMPs involves assessing the physical plant and grounds, personnel, equipment, production and process control systems, holding and distribution processes, recordkeeping, and procedures for handling recalls, product returns and product complaints.
Certification to ANSI for Dietary Supplements
Next, supplement manufacturers can work toward dietary supplement certification. In addition to passing twice-annual GMP audits, certification requires products to be tested to verify compliance with NSF/ANSI 173: Dietary Supplements, the official American National Standard for dietary supplement products. This includes:
- Label claims and content verification, as well as contaminant testing. Certification verifies the contents of the package are the same as the label and that there are no harmful levels of specific contaminants;
- Verification of product formulation and label claims through a toxicology review;
- Ongoing monitoring to verify compliance through periodic auditing and testing.
Certification to NSF/ANSI 173: Dietary Supplements provides a means to source safer products, raw materials and ingredients. Regardless of where ingredients are sourced, proper testing and qualification of suppliers is paramount to maintaining control over the supply chain and ensuring the quality and safety of finished products.
Sports Supplement & Ingredient Testing
Finally, supplement manufacturers can take an extra step and work toward independent certification for safer use by athletes. For example, the NSF Certified for Sport program builds on the NSF/ANSI 173: Dietary Supplements standard by screening for athletic banned substances. This rigorous certification program was developed with regulatory, sports industry and consumer groups to help athletes and consumers choose supplements that do not contain banned substances.
Because each product is unique, certification involves customized test methods relevant to the particular type of supplement. For example, ingredients known to contain aristolochic acid are assayed for it, botanicals are screened for pesticides, and glycerin products are tested for diethylene glycol.
Sports supplements are tested on a lot-by-lot basis for more than 245 athletic banned substances from the World Anti-Doping Agency (WADA), NSF Annex B, NFL and MLB prohibited substance lists. Testing covers various pharmacological activity classes, including anabolic steroids (e.g., testosterone and stanozolol), stimulants (e.g., amphetamine and DMAA), diuretics (e.g., chlorothiazide and bumetanide), beta agonists (e.g., albuterol and salmeterol), beta-blockers (e.g., atenolol and metoprolol), narcotics (e.g., morphine) and cannabinoids (e.g., THC), hormones and masking agents. This list is monitored and updated as new substances are discovered or banned. This is why the NSF Certified for Sport program is used by the NFL, NHL, MLB, PGA, LPGA, Canadian Centre for Ethics in Sport (CCES) and the New York City Police Department.
Increased Demand for Quality
The dietary supplements industry is responsible for ensuring product safety. More and more athletes are looking for certified products, and consumers are increasingly savvy, demanding transparency and trust. Being able to prove that what is on the label is actually what’s in the product is beneficial for producers, suppliers, retailers and consumers.
Testing and certification increase product quality and reduce the risk of adverse events caused by unidentified ingredients, of litigation and of regulatory action. Consumers and athletes can trust NSF/ANSI 173 and NSF Certified for Sport certification labels when purchasing supplements. They can be confident that consuming certified products will not result in accidental doping or adverse health effects.
Cheryl Luther, DC, is general manager of NSF International’s Dietary Supplements Program. She has extensive experience in physiotherapy and athletic performance as a sports practitioner, amateur and professional athlete, and coach. As a Certified Chiropractic Sports Physician (CCSP), she consults with athletes in the NBA, NFL and NHL, as well as U.S. Olympians and Para-Olympians.
