Not all supplements are created equal. For this reason, it’s essential to consider purchasing high-quality supplements from trusted sources. Whether you’re an individual looking for a supplement that doesn’t contain animal-sourced ingredients, a competitive athlete in need of sport-compliant supplements free of banned performance-enhancing ingredients, or you simply want peace of mind that your supplements are manufactured according to strict quality standards, third-party certifications can help guide you and your integrative healthcare practitioner in the decision-making process. Read on to learn more about third-party certifications and some of the most common certifications you may encounter when shopping for supplements.
What are third-party certifications?
Third-party certifications are independent programs offering inspections and testing of manufacturing sites, raw materials, and finished products of various consumer goods, such as food, beverages, and dietary supplements. A manufacturer may choose to utilize a third-party certifier’s services to provide unbiased verification of their product’s quality. There are dozens of third-party certifiers in North America, each establishing a set of standards that a manufacturer must meet for their product(s) to bear a seal of approval from the certifier. (4)
Third-party certified products typically display seals for each acquired certification directly on the product’s label to help consumers make informed decisions. Manufacturers may also provide information on their website regarding any certifications they have acquired. (4)
Did you know? While third-party certifications can increase consumer confidence in a product, these certifications don’t necessarily confirm a supplement’s efficacy. (1)
Third-party certifications quality standards
Many third-party certifiers evaluate supplement quality based on multiple factors, such as identity, strength, and purity. (15)
The Food and Drug Administration (FDA), which regulates various products such as food, cosmetics, supplements, and pharmaceutical drugs, doesn’t verify the contents of dietary supplements, and therefore many third-party certifiers are responsible for confirming the accuracy of a product’s label. Many third-party certifiers conduct routine site inspections and test finished products to ensure the supplements contain each ingredient included on the supplement facts label. Why is this important? Consumers depend on products being accurately labeled. Accurate labeling is essential for consumers who have allergies to certain ingredients or for those taking other supplements or medications that may interact with unlisted ingredients. (13) Certain populations, such as competitive athletes, also rely on accurately labeled products, considering that banned performance-enhancing ingredients may be found in some low-quality dietary supplements. (3)
Adulterated dietary supplements have become an increasingly concerning issue, making it even clearer the importance of selecting supplements with strict quality standards. According to a 2018 analysis of FDA supplement warnings between 2007 and 2016, unapproved pharmaceutical ingredients were found in over 700 supplements, particularly in products marketed for sexual enhancement, bodybuilding, or weight loss. (10)
Did you know? According to the Food Allergen Labeling and Consumer Protection Act of 2004, supplement manufacturers must disclose the presence of any major allergens in their product, including milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. (13)
Manufacturers are required to include information on the supplement facts label indicating the amount per serving of any active ingredients. Some third-party certifiers test finished products or batches to ensure that the strength, concentration, weight, and/or measure is accurately listed on the label. Having precise information is necessary because it influences serving sizes and dosages for supplements. Furthermore, inaccurate labeling may affect a product’s expected efficacy. (14) For example, if a vitamin D supplement states it contains 500 IU but only contains half that amount, you may not experience the same benefits as you would if the supplement truly contained the advertised amount.
Third-party testing can determine whether a product is free of contaminants, such as heavy metals, bacteria, or pesticides. (4) Poor quality control can increase the risk of contamination. (6) To prevent the unnecessary introduction of these potentially harmful contaminants into their products, manufacturers may utilize third-party certifiers to perform routine inspections and evaluations of their various manufacturing practices. These inspections can ensure that manufacturers are maintaining safe and sanitary operations. (17)
Did you know? One investigation demonstrated that four out of five products pulled from the shelves of major retailers such as GNC, Target, Walgreens, and Walmart didn’t contain any of the herbs listed on the supplement’s label. (9)
Supplement regulation: what you need to know
Supplements manufactured and sold in North America are regulated by government authorities and must meet specific quality standards.
In the United States, the FDA regulates dietary supplements and their labels under the Dietary Supplement Health and Education Act (DSHEA) of 1994. It’s important to note that dietary supplements are held to much less rigorous standards than pharmaceutical drugs; in fact, the FDA does not review dietary supplement products for safety or effectiveness before they are available for purchase by consumers. Instead, manufacturers are responsible for ensuring that their products are safe to use before they’re marketed. (16)
Manufacturers are also required to produce supplements in accordance with current Good Manufacturing Practices (cGMP). Sometimes referred to as GMP, cGMP is a registration program and set of standards enforced by the FDA. (17) The program provides independent audits for manufacturers and distributors of various products, including food, beverages, cosmetics, pharmaceuticals, and supplements. Products displaying a cGMP seal confirm that the manufacturer complies with all standards, procedures, and documentation regarding its identity, strength, purity, and more. (12)
In Canada, supplements and other natural health products are regulated by the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada under the Natural Health Products Regulations of 2004. Similar to the United States, manufacturers in Canada must hold a site license and produce supplements in compliance with Good Manufacturing Practices, which outlines specific standards for product testing, manufacturing, storage, and distribution. (5)
Common third-party certifications
Outlined below are some of the most common third-party certifications utilized by supplement manufacturers in North America.
If you avoid gluten, the naturally occurring protein found in wheat, barley, and rye, selecting products bearing a Certified Gluten-Free certification mark can help reduce your risk of exposure. According to a 2014 ruling by the FDA, a product cannot be Certified Gluten-Free unless it contains less than 20 parts per million (ppm) of gluten. 20 ppm is considered the safe threshold for individuals who must avoid gluten, such as those with celiac disease. (7)(18) Through routine manufacturing site inspections and product sampling, the FDA ensures that Certified Gluten-Free products are accurately represented and safe to consume. (18)
The National Sanitation Foundation, most commonly referred to as NSF, is an independent certification program that grants its seal of approval to products meeting purity standards. NSF certifies products in accordance with NSF/ANSI 173, an American National Standard that sets strict standards for the ingredients used in dietary supplements. NSF evaluates products for unacceptable levels of contaminants, such as heavy metals (e.g., lead, arsenic), pesticides, and herbicides. Additionally, NSF tests products to confirm that their label accurately displays all ingredients and that the product is compliant with cGMPs. (3)
NSF also certifies sport-safe dietary supplements for competitive athletes. The NSF Certified for Sport certification process routinely tests products to confirm that they are free of contaminants, masking agents, and over 270 substances banned by major athletic organizations. (3)
U.S. Pharmacopeia (USP) is a large independent quality evaluation program used to evaluate supplement and pharmaceutical drug quality. Products bearing a USP seal must conform to all USP standards, including:
- Identity: The supplement contains all ingredients indicated on the label.
- Potency: The potency of the product indicated on the label is accurately represented.
- Purity: The supplement is free of contaminants and unlabeled ingredients.
- Performance: The supplement dissolves, which allows the body to absorb the active ingredients.
To maintain USP certification, manufacturers must undergo routine site and product inspections. USP also performs random testing of off-the-shelf products displaying their seal. (19)
Supplements, as well as food and beverages, displaying the USDA Organic certification must contain at least 95% organic ingredients according to the United States Department of Agriculture. Certified organic ingredients are grown and processed in accordance with federal requirements that outline standards for numerous factors, including soil quality, pest and weed control, use of additives, and livestock care practices. (11)
Did you know? Ingredients must be grown without prohibited fertilizers, pesticides, or herbicides for a minimum of three years before harvesting to become eligible for organic certification. (11)
Non-GMO Project Verified
Non-GMO Project Verified is a voluntary third-party evaluation program used to designate food, beverages, and dietary supplements free of genetically modified ingredients (GMOs). Products undergo an independent evaluation and continued annual product verification process to ensure they don’t contain GMOs to obtain certification. (8)
International Fish Oil Standards
International Fish Oil Standards (IFOS) is a set of quality standards specific to fish oil supplements. To become IFOS-certified, omega-3 fish oil products must be analyzed for purity and label accuracy, including testing for contaminants such as heavy metals, dioxins, and polychlorinated biphenyls (PCBs). For increased transparency, results for all products tested by IFOS are published online. (2)
Certified Vegan is a registered trademark used to specify foods and supplements free of animal products and animal by-products, including meat, fish, poultry, eggs, milk, honey, insects, and sweeteners filtered with bone char. Use of the trademark is voluntary and manufacturers must first certify their product(s) by providing detailed documentation that outlines the sources of all raw materials. Additionally, manufacturers must provide documentation that describes the manufacturing processes involved in producing the product, which is then evaluated by the Vegan Awareness Foundation. (20)
The bottom line
In addition to choosing high-quality supplements from reputable sources, third-party certifications, such as Certified Gluten-Free, NSF, or USP, can help you make informed decisions. If you’re a patient, the best first step before purchasing dietary supplements is to speak to your integrative healthcare practitioner. They can help determine which high-quality supplement products are right for your preferences and wellness plan.
- Akabas, S. R., Vannice, G., Atwater, J. B., Cooperman, T., Cotter, R., & Thomas, L. (2016). Quality certification programs for dietary supplements. Journal of the Academy of Nutrition and Dietetics, 116(9), 1370–1379.
- Certifications by Nutrasource. (n.d.). Certified products. https://certifications.nutrasource.ca/certified-products?type=certification&value=IFOS
- Certified for Sport. (n.d.). Certified for Sport frequently asked questions. https://www.nsfsport.com/news-resources/documents/ds_cert_for_sport_faq.pdf
- Consumer Reports. (2019). How to choose supplements wisely. https://www.consumerreports.org/supplements/how-to-choose-supplements-wisely/
- Health Canada. (2020). Natural and non-prescription health products directorate. https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/natural-non-prescription-health-products-directorate.html
- Korfali, S. I., Hawi, T., & Mroueh, M. (2013). Evaluation of heavy metals content in dietary supplements in Lebanon. Chemistry Central Journal, 7(1), 10.
- National Celiac Association. (n.d.). Understanding gluten levels. https://nationalceliac.org/celiac-disease-questions/understanding-gluten-levels/
- Non-GMO Project. (n.d.). Product verification – the Non-GMO project. https://www.nongmoproject.org/product-verification/
- O’Connor, A. (2015, February 3). New York attorney general targets supplements at major retailers. Well. https://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/
- Tucker, J., Fischer, T., Upjohn, L., Mazzera, D., & Kumar, M. (2018). Unapproved pharmaceutical ingredients included in dietary supplements associated with US food and drug administration warnings. JAMA Network Open, 1(6), e183337.
- U.S. Department of Agriculture. (2012, March 22). Organic 101: What the USDA organic label means. USDA. https://www.usda.gov/media/blog/2012/03/22/organic-101-what-usda-organic-label-means
- U.S. Food and Drug Administration. (2018a, June 25). Facts about the Current Good Manufacturing Practices (CGMPs). https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
- U.S. Food and Drug Administration. (2018b, July 16). Food allergen labeling and consumer protection act of 2004 (FALCPA). https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/food-allergen-labeling-and-consumer-protection-act-2004-falcpa
- U.S. Food and Drug Administration. (2018c, September 20). Small entity compliance guide: Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-current-good-manufacturing-practice-manufacturing-packaging-labeling
- U.S. Food and Drug Administration. (2019a, July 22). Questions and answers on dietary supplements. https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements
- U.S. Food and Drug Administration. (2019b, August 16). Dietary supplements. https://www.fda.gov/food/dietary-supplements
- U.S. Food and Drug Administration. (2020a, January 31). Current Good Manufacturing Practices (CGMPs) for food and dietary supplements. https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements
- U.S. Food and Drug Administration. (2020b, August 13). Questions and answers on the Gluten-Free food labeling final rule. https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-gluten-free-food-labeling-final-rule
- USP. (n.d.). Dietary supplements & herbal medicines. https://www.usp.org/dietary-supplements-herbal-medicines
- Vegan Action. (2021, March 25). Certification. https://vegan.org/certification/