How Safe Are Supplements? Understanding FDA Regulation and Third-Party Testing
Protein powders and dietary supplements are among the most popular products in the health, fitness, and wellness world. From athletes trying to build muscle to everyday people looking to fill nutritional gaps, these products are everywhere. But how regulated are they? And how can consumers know what they’re really getting? Let’s unpack the facts.
How the FDA Regulates Dietary Supplements (Including Protein Powder)
Supplements Are Treated as Food, Not Drugs
Under U.S. law, dietary supplements including protein powders, vitamins, amino acids, and herbal products are regulated as a category of food, not as drugs. This regulatory framework was established by the Dietary Supplement Health and Education Act (DSHEA) of 1994.
Because of this:
The FDA does not approve supplements for safety, effectiveness, or label claims before they’re sold. Unlike prescription drugs, companies can bring most products to market without prior approval from the FDA.
Manufactures are legally responsible for ensuring their products are safe and truthfully labeled before sale.
The FDA’s authority begins after a product is on store shelves: it can inspect facilities, review labels , investigate complaints, monitor adverse events, and if necessary act to remove products found to be unsafe or misbranded.
Labeling Rules vs Health Claims
Supplements must carry a “Supplement Facts” panel and accurately list ingredients and amounts. But:
They cannot legally claim to diagnose, treat, cure, or prevent disease unless such claims are approved like a drug claim, which is rare.
They can make structure-function claims (ex., “supports muscle recovery”), but these must be truthful and include the FDA disclaimer that the claim hasn’t been evaluated by the FDA
In short, supplement companies can sell products freely as long as they follow labeling, manufacturing, and safety laws but, the FDA typically won’t review those products before you buy them.
What This Means for Protein Powder
Protein powders fall under these same dietary supplement rules. That means:
You could see widely varying levels of quality and ingredient accuracy across brands and products.
The FDA does not routinely test or verify protein powder contents before sale.
Contaminants like heavy metals (ex., lead, calcium, arsenic) can be present at different levels depending on raw materials and manufacturing practices and oversight on this is largely reactive, not preemptive.
This doesn’t mean all products are unsafe =, many are formulated responsibly, but it does mean market quality varies. Some products may have more of what they claim and fewer contaminants; others may not.
Why Third-Party Testing and Certification Exists
Given the gaps in pre-market regulation, independent third-party testing and certification have become essential tools for consumers who want assurance beyond what the FDA enforces.
What Third-Party Testing Does
Third-party companies are independent organizations that evaluate supplements for things like:
Purity - checking for contaminants like heavy metals, pesticides, solvents, or microbes
Potency - verifying the product contains the ingredients in the amounts listed on the label.
Quality of manufacturing - ensuring facilities and practices meet good standards.
Label accuracy - confirming that what’s in the product matches the label.
A product that passes these evaluations can display a third-party certification seal, signaling to consumers that an independent expert has verified key aspects of the product’s quality.
Why This Matters
Because the FDA doesn’t verify supplements before sale, third-party certification helps fill that trust gap.
Some third-party programs test specifically for banned substances which is especially important for athletes or anyone subject to drug testing.
Independent seals give consumers greater confidence that a product contains what it says it does and meets basic quality standards.
Well-known third-party programs include NSP International, USP (U.S. Pharmacopeia), Informed Choice, and others, each with their own testing criteria.
What Should Consumers Do?
Look for trusted third-party certification seals
Read labels carefully - check serving size, amounts, and ingredients lists.
Research brands and manufacturing practices - reputable brands often publish Certificates of Analysis (COAs).
Talk with a health professionals
Report adverse events to the FDA or manufacturer
References:
U.S. Food and Drug Administration. (n.d.). Dietary supplements. https://www.fda.gov/food/dietary-supplements
U.S. Food and Drug Administration. (n.d.). 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. (n.d.). Information for consumers on using dietary supplements. https://www.fda.gov/food/dietary-supplements/information-consumers-using-dietary-supplements
U.S. Food and Drug Administration. (n.d.). Dietary supplements guidance documents & regulatory information. https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/dietary-supplements-guidance-documents-regulatory-information
Dietary Supplement Health and Education Act of 1994. (1994). Public Law 103-417. Retrieved from https://en.wikipedia.org/wiki/Dietary_Supplement_Health_and_Education_Act_of_1994
NSF International. (n.d.). Dietary supplement and vitamin certification [Web page]. https://www.nsf.org/consumer-resources/articles/supplement-vitamin-certification
Operation Supplement Safety. (n.d.). Why is third-party certification important for dietary supplements? https://www.opss.org/article/why-third-party-certification-important-dietary-supplements
Akabas, S. R. (2016). Quality certification programs for dietary supplements [Article]. Journal of the Academy of Nutrition and Dietetics. https://www.jandonline.org/article/S2212-2672%2815%2901642-1/fulltext
U.S. Department of Health and Human Services, National Institutes of Health, Office of Dietary Supplements. (2023). Dietary supplements: What you need to know. https://ods.od.nih.gov/factsheets/WYNTK-Consumer/
ConsumerLab.com. (n.d.). About ConsumerLab.com. https://www.consumerlab.com/about/
NSF International. (n.d.). NSF International. https://www.nsf.org/
ConsumerLab.com. (n.d.). ConsumerLab.com [Wikipedia entry]. https://en.wikipedia.org/wiki/ConsumerLab.com
United States Pharmacopeia. (n.d.). United States Pharmacopeia [Wikipedia entry]. https://en.wikipedia.org/wiki/United_States_Pharmacopeia
