Regulatory Oversight of Supplements, Lab Tests and Clinic Claims: Who Checks What
Who checks supplements, lab tests, practitioner credentials and clinic marketing claims, mainly in the United States, what each check does and does not cover, with dates.
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Supplements (United States)
| Question | What the source says |
|---|---|
| Who regulates them? | The FDA regulates finished dietary supplement products and dietary ingredients, under a different set of regulations than conventional foods and drugs. [1] |
| Who is responsible for safety before sale? | Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers and distributors are responsible for evaluating the safety and labeling of their products before marketing. [1] |
| Does the FDA approve them first? | The FDA does not have authority to approve supplements for safety and effectiveness, or to approve their labeling, before sale. [2] |
| When can the FDA act? | It can act against adulterated or misbranded supplements after they reach the market. [1] |
| Is there any premarket review? | NCCIH notes companies must submit safety data for any new ingredient not sold in a supplement before 1994. [3] |
| Are problems reported? | Firms must report serious adverse events to the FDA within 15 days, and consumers and clinicians can report problems too. [2] |
NCCIH adds that rules for making and distributing supplements are less strict than those for prescription or over-the-counter drugs, and that the FDA says it cannot test every product for hidden ingredients (NCCIH page last updated January 2019). [3] For label reading see how supplements are regulated and supplements in integrative practice.
What a label may and may not claim
The FDA says a product intended to treat, prevent, cure or alleviate symptoms of a disease is a drug, even if labeled a supplement. [2] Claims about the structure or function of the body are not pre-approved by the FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading. [4] Such a label must carry a disclaimer that the FDA has not evaluated the claim. [4] So "supports" wording on a bottle is not an FDA finding of benefit.Lab tests and consumer tests (United States)
| Type | What the source says |
|---|---|
| Laboratories | The Centers for Medicare & Medicaid Services (CMS) runs the Clinical Laboratory Improvement Amendments (CLIA) program, whose objective is to ensure quality laboratory testing. [5] State agencies are authorized to set and enforce CLIA standards. [5] |
| Direct-to-consumer tests | The FDA says tests for general wellness or low-risk medical purposes are generally not reviewed before they are offered, while those for moderate to high risk medical purposes generally are. [6] It adds that these tests have varying levels of evidence behind their claims. [6] |
| Tests made and run in one lab | The FDA's page (current as of September 2025) says a 2024 rule on laboratory developed tests was vacated by a federal court on March 31, 2025, and the FDA then reverted the regulation to its earlier text. [7] |
The FDA separates whether a test measures what it claims (analytical validity) from whether the result predicts a state of health (clinical validity). [6] The CMS page we read describes CLIA as aimed at quality testing; it does not say that CLIA judges clinical validity. [5] See tests sold in integrative practice and home and direct-to-consumer tests.
Practitioners and titles
NCCIH says there is no standardized national system for credentialing complementary health practitioners, and that state governments decide what credentials are needed. [8] Licensing requirements for naturopathic physicians vary across U.S. states and territories. [9] A 2018 NCCIH fact sheet said only 17 states and the District of Columbia license naturopathic physicians; that number is dated, so see naturopathic doctor licensing by state. NCCIH also cautions that being licensed or certified is not always a guarantee of being qualified. [8]In England, the NHS page (reviewed May 2026) says chiropractors and osteopaths must be registered by law, while other complementary therapists and herbal medicine practitioners do not need to be registered by law. [10] It advises choosing a therapist registered with an organization accredited by the Professional Standards Authority. [10] A traditional herbal registration mark on a product shows it has been licensed for use in England. [10] We could not read the Health Canada, Australian TGA or NHMRC pages, so for those countries see regulation in Canada, the UK, Australia and elsewhere.
Clinic marketing and claims
NCCIH reports that the FDA and the Federal Trade Commission have taken action against several companies selling detox or cleansing products that contained hidden ingredients, made false claims of treating serious diseases, or marketed colon-cleansing devices for unapproved uses. [11] We could not read the FTC's own guidance, so we do not summarize its advertising rules. The FDA treats disease-treatment claims as drug claims. [2] See red flags in marketing.What this means for you
- A supplement on a shelf has not been approved by the FDA for safety or effectiveness first. [2]
- A lab or test company can be real and certified without its test being proven useful for the marketed purpose.
- A license shows legal status. NCCIH says regulations, licenses or certificates do not guarantee safe, effective treatment from any health care provider. [9]
- Tell your doctor about everything you take, and report problems to the regulator named above.
- Do not stop a prescribed medicine, and do not delay care for serious symptoms.
Frequently asked questions
Does the FDA approve dietary supplements?
No. It does not have authority to approve them for safety and effectiveness before sale. [2]
Can a supplement label say it treats a disease?
Generally no. A product intended to treat or cure a disease is treated as a drug. [2]
Who checks a lab test?
In the United States CLIA, run by CMS, aims at quality laboratory testing. [5] The FDA reviews some tests, depending on risk. [6]
Who licenses naturopathic doctors?
In the United States, states do, and rules vary. [8][9]
Where do I report a problem with a supplement?
The FDA asks consumers and health professionals to report adverse events to the FDA. [2]
References
- Dietary Supplements, US Food and Drug Administration (content current as of 10/01/2024). Read 2026-10-22.
- FDA 101: Dietary Supplements, US Food and Drug Administration (content current as of 06/02/2022). Read 2026-10-22.
- Using Dietary Supplements Wisely, NCCIH (last updated January 2019). Read 2026-10-22.
- Structure/Function Claims, US Food and Drug Administration. Read 2026-10-22.
- Clinical Laboratory Improvement Amendments (CLIA), Centers for Medicare & Medicaid Services (page last modified 10/07/2026). Read 2026-10-22.
- Direct-to-Consumer Tests, US Food and Drug Administration. Read 2026-10-22.
- Laboratory Developed Tests, US Food and Drug Administration (content current as of 09/19/2025). Read 2026-10-22.
- Credentialing, Licensing, and Education, NCCIH (last updated May 2018). Read 2026-10-22.
- Naturopathy, NCCIH (last updated April 2025). Read 2026-10-22.
- Herbal medicines and complementary therapies, NHS (UK), page last reviewed 1 May 2026. Read 2026-10-22.
- “Detoxes” and “Cleanses”: What You Need To Know, NCCIH (last updated March 2025). Read 2026-10-22.