The 5 Red Flags I Look For on a Supplement Label

The FDA does not approve dietary supplements before they are marketed.¹ The five warning signs below, which can appear on a label or in a product’s marketing, come from the FDA, federal labeling rules and the Federal Trade Commission.

How supplements are regulated

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA “does not have the authority to approve dietary supplements before they are marketed.”¹ The FDA states that it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements,² and that many dietary supplements can be marketed without even notifying the FDA.³

The National Center for Complementary and Integrative Health (NCCIH) puts it this way: marketers of a supplement “do not have to prove to the Food and Drug Administration that it is safe or that it works before it arrives on grocery store shelves.”⁴ The NIH Office of Dietary Supplements notes that the FDA “does not determine whether dietary supplements are effective before they are marketed.”⁵

Red flag 1: A claim of “FDA approval”

“By statute, the FDA does not approve dietary supplements for safety and effectiveness.”U.S. Food and Drug Administration³

The FDA also states that by law it does not approve dietary supplements or their labeling, although certain types of claims, such as health claims, require premarket review and authorization.¹

The FDA advises caution when a product is marketed as being made in an FDA-approved facility, because “FDA does not approve facilities.”⁶ An FDA fact sheet for retailers lists misusing the FDA logo among product characteristics that “warrant further investigation,”⁷ and the FDA states that misuse of its logo may violate federal law.³

Red flag 2: Claims to treat, cure or prevent a disease

Federal law allows supplement labels to carry certain statements about how a product affects the structure or function of the body.⁸ Such a statement “may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.”⁸ Under FDA regulations, a supplement that makes a disease claim becomes subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies.⁹

When a label does make a structure/function claim, federal rules require this disclaimer, placed next to the claim or linked to it with a symbol such as an asterisk: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”⁹

The FDA’s list of health-fraud tip-offs also warns: “Be suspicious of products that claim to cure a wide range of diseases.”¹⁰

Red flag 3: Promises of fast or guaranteed results

The FDA’s tip-offs include “quick fixes,” noting that “few diseases or conditions can be treated quickly, even with legitimate products,” and give “Lose 30 pounds in 30 days” as an example. They also include “miracle cure” claims and phrases such as “new discovery,” “guaranteed results” and “secret ingredient.”¹⁰

The same FDA page reports that, in recent years, FDA laboratories “have found hundreds of weight-loss products, illegally marketed as dietary supplements,” that contained sibutramine, “a Schedule IV controlled substance.”¹⁰ The FDA advises: “Be especially wary of products sold for sexual enhancement and energy, weight loss, pain, bodybuilding or sleep.”⁶ The FDA’s fact sheet for retailers adds that the agency has identified over a thousand products marketed as dietary supplements or conventional foods with hidden drugs and chemicals.⁷

Red flag 4: Testimonials in place of evidence

The FDA’s tip-offs note that personal “success” stories “are easy to make up and are not a substitute for scientific evidence.”¹⁰

The Federal Trade Commission’s Health Products Compliance Guidance states that, as a general rule, claims about the health benefits or safety of dietary supplements and other health-related products require substantiation in the form of “competent and reliable scientific evidence.” It also states that anecdotal evidence about the individual experiences of consumers is “never sufficient to substantiate claims about the effects of a health product.”¹¹

Red flag 5: Vague or missing company information

The FDA’s fact sheet for retailers lists “products with vague or no company information on product labels” among product characteristics that “warrant further investigation.” The same list includes labels in a foreign language that say “Made in the USA.”⁷

Dietary supplement labels must provide a domestic address or domestic phone number for reporting serious adverse events.¹

Other label details, explained

Proprietary blends

Under FDA labeling rules, a proprietary blend’s dietary ingredients that have no established Daily Value are listed in descending order of predominance by weight, and the amount shown is the total weight of those ingredients. Nutrients such as vitamins and minerals in a blend must still be declared with their individual amounts.¹²

“Natural” does not necessarily mean safe

The FDA states: “Do not assume that the term ‘natural’ to describe a product ensures that it is safe.”² NCCIH states: “‘Natural’ does not necessarily mean ‘safe.’”⁴

Quality seals

According to USP, its Verified Mark indicates that a product contains the ingredients listed on the label in the declared strength and amounts, does not contain harmful levels of specified contaminants, complies with FDA Good Manufacturing Practices, and will break down and dissolve within a specified amount of time.¹³ According to NSF, its certification includes a label claim review “to certify that what’s on the label is in the bottle” and a contaminant review “to ensure the product contains no undeclared ingredients or unacceptable levels of contaminants.”¹⁴

The NIH Office of Dietary Supplements, which names ConsumerLab.com, NSF International and U.S. Pharmacopeia as examples of organizations that offer quality testing, states that these seals “do not guarantee that a product is safe or effective.”⁵

Interactions with medicines and surgery

The NIH Office of Dietary Supplements notes that “Vitamin K can reduce the ability of the blood thinner warfarin to prevent blood from clotting,” that “St. John’s wort can speed the breakdown of many medicines and reduce their effectiveness,” and that “some supplements can increase the risk of bleeding or, if taken before surgery, can change your response to anesthesia.” It advises: “Tell your health care providers (including doctors, dentists, pharmacists, and dietitians) about any dietary supplements you’re taking.”⁵

Reporting a problem

The FDA states: “If you experience an adverse event while taking a dietary supplement, immediately stop using the supplement, seek medical care or advice, and report the adverse event to the FDA.” Supplement companies are required to report serious adverse events they receive to the FDA.² The FDA’s reporting page directs consumers to file reports through the Safety Reporting Portal.¹⁵

The FDA also maintains a Health Fraud Product Database, and notes that “this list only includes a small fraction of the potentially hazardous products” marketed to consumers.¹⁶

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This article is for general information only and is not medical advice. It does not replace a conversation with a licensed health care professional about your own health. Do not start, stop or change a prescribed medication without talking to your prescriber. In an emergency, call 911.