Vitamins & Dietary Supplements

Advertising Law: The Basics

A Snapshot of the Vitamin & Dietary Supplements Industry in 2023

As of 2023, the market size of the Vitamin & Supplement Manufacturing industry in the U.S., measured by revenue, is $39.9 billion.[1] By contrast, the market size of the meat industry in the U.S. measured by revenue is $8 billion.[2] Worldwide, the dietary supplements market is estimated at $155 billion in 2022.[3]

Consumer interest in health and self-care have driven the market for vitamins and supplements.[4] Half of American adults take supplements in the belief that they compensate for poor diets, according to The Supplement Paradox: Negligible Benefits, Robust Consumption (2016).

Approximately 80% of Americans are now using dietary supplements.[5] In other words, four out of five Americans use dietary supplements.

Which Dietary Supplements are Purchased Most by Americans?

• Multivitamins remain the most used supplements, accounting for about 75% of all supplement users.[6]
• Vitamin D (51% in 2021 versus 42% in 2020);
• zinc (22% in 2021 versus 15% in 2020); vitamin C (40% in 2021 versus 35% in 2020).[7]

Other substances marketed as dietary supplements include: minerals, herbs, botanicals, amino acids, animal-derived products, hormones, hormone analogs, enzymes, concentrates, metabolites, constituents, or extracts of these.[8]

These statistics, taken by survey by the Council for Responsible Nutrition (CRN), which runs annually since 2022, also show that 79% of Americans believe that the dietary supplements industry is “trustworthy.”[9]

The FDA “estimates that 29,000 different dietary supplements are now available to consumers, and an average of 1,000 new products are introduced annually (Sarubin 2000).”[10]

Dietary supplement manufacturers capitalize on these trends by exploiting the weaknesses in the FDA’s regulation of these products.[11] Manufacturers sneakily advertise using “structure-function claims” which consumers often mistakenly assume to the same as FDA-regulated health claims and disease claims.”[12] A deep dive into the nuances of these claims are below.

Which Federal Laws Govern the Regulation of Dietary Supplements in the United States?

The Federal Food, Drug, and Cosmetic Act (FDCA) regulates dietary supplements [and drugs] in the United States. The Food and Drug Administration (FDA) carries out the FDCA by enforcing product-labeling law for products within its purview, including vitamins and supplements. The Federal Trade Commission (FTC) governs non-label advertising claims and direct-marketing materials. Dietary supplements sold online are regulated by both the FDA and the FTC.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines and regulates dietary supplements. It prohibits the marketing of products that are adulterated or misbranded. It defines dietary supplements as products intended to supplement the diet using one more dietary ingredients including:

• minerals
• herbs
• botanicals
• amino acids
• animal-derived products
• hormones
• hormone analogs
• enzymes
• concentrates
• metabolites
• constituents, or extracts of these

DSHEA also regulates the labeling of dietary supplements, including ingredients, recommended daily use, along with the use of the ubiquitous disclaimer, “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." Substantive regulation of dietary supplements through DSHEA is separate from the framework that regulates conventional drugs. But both are policed by the FDA.

Under federal law, a “label” means a display of written, printed, or graphic matter upon the container. 21 U.S.C. § 321(k). The word “labeling” means all labels and other written, printed, or graphic matter upon the product or any of its containers, wrappers, or accompanying promotional material. 21 U.S.C. § 321(l).

What is a “Structure-Function” claim in Dietary Supplements?

A structure-function claim is a type of "health claim" that asserts a relationship between a product’s structure and its effect on the body’s structure, or on the body’s function. The other type of health claim is a "risk-reduction" claim explained in the next section.

A structure-function claim implies a role of a particular substance (a food, food component, or dietary ingredient) as a “constituent for growth, development, or normal physiological function of the body.[13] The substance allegedly aids in the normal functioning of the body.[14] Structure-function claims often relate to general well-being and nutritional deficiencies. Structure-function claims are not subject to premarket approval. But the claims must be substantiated as “truthful and not misleading.”

DSHEA requires manufacturers to meet three requirements for placing a structure/function claim on a supplement label:

1. Substantiation that the claim is truthful and not misleading,
2. Notification to FDA within 30 days of marketing the supplement with the claim, and
3. A disclaimer on the supplement label. 21 U.S.C. § 343(r)(6).

The DSHEA requires all products with structure-function claims to contain the disclaimer, “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.”[15]

Structure-function claims may not use the following words:

• disease
• antiviral
• antibacterial
• antiseptic
• antibiotic
• analgesic
• diuretic
• antidepressant
• vaccine
• any other word relating to a disease or class of diseases

Examples of Permissible Structure-Function Claims in Dietary Supplements (if true and substantiated):

• “A diet high in calcium aids in the growth and maintenance of bones”[16]
• “Promotes joint health”
• “Supports immune system”
• “Supports urinary tract health”
• “Supports better mood”
• “Helps maintain cardiovascular function”
• “Helps maintain a healthy blood sugar as part of a healthy diet”[17]
• “Helps maintain healthy cholesterol levels”
• “Helps reduce stress and tension”
• “Helps maintain proper joint function”

Examples of Impermissible Structure-Function Claims in Dietary Supplements:

• “Lowers cholesterol”
• “Prevents cold and flu”
• “Improves mood to help ease depression”
• “Relieves chronic bowel inflammation”
• “For chronic indigestion”
• “Relieves painful joints”
• “Lowers serum cholesterol levels”
• “Helps maintain healthy blood sugar to combat diabetes”
• “Suppresses appetite of people with diabetes”
• “Helps reduce joint pain and joint inflammation”
• “Stops hangovers" or "prevents hangover”
• “Helps alleviate depression”
• “Stimulates the body’s antiviral capacity”
• “Maintains normal intestinal flora for people using antibiotics”
• “Alleviates male impotence”

Here is the FDA’s “Compliance Guide” on structure-function claims.

Does the Law also address Implied Advertising Claims of Vitamins & Dietary Supplements?

Yes. All dietary supplement claims, whether express or implied, whether on a label or off a label, must not be deceptive. Deception is regulated by the FDA and the FTC. Implied claims include statements, language, images, symbols, or any communication that implies a relationship between an ingredient and a disease or health condition. Other forms of regulated product assertions include product names, testimonials, endorsements, research citations, and even the meta-tags tied to a company's website.

All advertising claims must be truthful and not misleading. Product claims must be substantiated with scientific evidence, and must comply with regulations on formatting, such as placement, and type-size requirements.

What is a “Risk-Reduction” Claim in Dietary Supplements?

A “risk-reduction” advertising claim states or implies that the consumption of a specific substance reduces the development of a human disease.[18] A substance is a food, food component, or dietary ingredient. A risk-reduction claim is considered a “health claim” under the FDCA and is subject to premarket approval by the FDA. As with all supplement advertising claims, a risk-reduction claim must be truthful, not misleading, and and substantiated by evidence. Products containing these claims are subject to pre-approval by the FDA.

Any risk-reduction claim that has not been approved by the FDA is non-compliant. Any risk-reduction claim that deviates from what was approved by the FDA is non-compliant. Any product that uses a pre-approved risk-reduction claim that lacks the FDA disclaimer is non-compliant. The disclaimer is “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."

Examples of Impermissible Risk-Reduction Claims in Supplements:

• “Helps reduce the risk of cancer”
• “Protects against the development of cancer”
• “Treats diabetes”
• “Eating a diet rich in fruits and vegetables may reduce the risk of heart disease”
• “Eating calcium-rich dairy products may reduce the risk of osteoporosis”
• “Folic acid consumption may reduce the risk of birth defects”
• “A healthy diet may reduce the risk of type 2 diabetes”
• “Consuming whole grains may reduce the risk of colorectal cancer”

What is a “Disease” Claim in Dietary Supplements?

A “disease” claim refers to a disease or class of diseases. A disease claim states or implies that a particular substance “helps diagnose, cure, treat, mitigate, or prevent disease.” A disease claim is considered a drug claim under the FDCA, and is subject to premarket approval by the FDA.

Using a disease claim on a dietary supplement is not permitted since it is considered a drug with different testing and premarket approval standards. Even a structure-function claim that implies disease management is misleading and is not compliant with federal law.

Examples of Non-compliant Disease Claims in Supplements:

Similar to non-compliant risk-reduction claims, the below are some impermissible disease claims that are disallowed for use in dietary supplements:

• “Calcium cures osteoporosis.”
• “Treats high blood pressure”
• “Approved for the treatment of Aids”
• “Prevents the onset of flu”
• “Slows down the progression of Alzheimer’s disease”
• “Treats schizophrenia”

13 Examples of Dangerous Products that were Banned for Making Disease Claims in Dietary Supplements:

1. Ephedra: This dietary supplement was banned in 2004 after several reports of serious adverse events, including heart attacks and strokes, linked to its use. Some dietary supplement manufacturers had made false or misleading claims that ephedra could aid in weight loss and increase energy levels.
2. Hydroxycut: This dietary supplement was banned in 2009 due to reports of serious liver injury, including liver failure, associated with its use. Hydroxycut had been marketed as a weight-loss aid, and some manufacturers had made false or misleading claims about its safety and efficacy.
3. 5-HTP: This dietary supplement was banned in the early 2000s due to reports of serious adverse events, including seizures and muscle damage, linked to its use. Some manufacturers had made false or misleading claims that 5-HTP could treat or prevent serious illnesses, such as depression or anxiety.
4. Kava: This dietary supplement was banned in 2002 due to reports of serious liver toxicity associated with its use. Some manufacturers had made false or misleading claims that kava could treat or prevent anxiety and other conditions.
5. Dehydroepiandrosterone (DHEA): This dietary supplement was banned in the early 2000s due to false claims that it could increase muscle mass and athletic performance, as well as false claims that it could prevent or treat serious illnesses, such as cancer and heart disease.
6. 4-Methylaminorex (4-MAR): This dietary supplement was banned in the early 2000s due to false claims that it could increase energy levels and improve cognitive function.
7. Tryptophan: This dietary supplement was banned in the early 1990s due to false claims that it could treat or prevent serious illnesses, such as depression, anxiety, and insomnia.
8. Synephrine: This dietary supplement was banned in the early 2000s due to false claims that it could increase metabolism and aid in weight loss.
9. Juglone: This dietary supplement was banned in the early 2000s due to false claims that it could prevent or treat serious illnesses, such as cancer and heart disease.
10. OxyELITE Pro: This dietary supplement was banned in 2013 due to false claims that it could aid in weight loss and increase energy levels, as well as several reports of liver injury associated with its use.
11. Triacana: This dietary supplement was banned in the early 2000s due to false claims that it could treat or prevent obesity and related conditions.
12. 7-Keto: This dietary supplement was banned in the early 2000s due to false claims that it could increase metabolism and aid in weight loss.
13. Phenylpropanolamine (PPA): This dietary supplement was banned in the early 2000s due to false claims that it could suppress appetite and aid in weight loss, as well as several reports of serious adverse events, including heart attacks and strokes, linked to its use.

20 examples of mislabeling on weight-loss products?

1. Mislabeling in weight-loss products can take various forms, and it is essential to note that these examples are not exhaustive. Here are 20 examples of mislabeling that have been observed in weight-loss products:
2. False or exaggerated claims of rapid weight loss (e.g., "Lose 10 pounds in one week!")
3. Misrepresentation of ingredients or their quantities in the product.
4. Unauthorized use of health claims or endorsements without scientific evidence.
5. Omission of potential side effects or risks associated with the product.
6. Labeling a product as "natural" or "herbal" when it contains synthetic or undisclosed ingredients.
7. Falsely claiming that the product is "clinically proven" or "doctor recommended."
8. Use of misleading before-and-after photos to promote the product's effectiveness.
9. Misleading portion sizes or servings per container to make the product appear more effective or economical.
10. Incorrect or misleading nutrition facts, including calorie counts or macronutrient information.
11. Falsely claiming that the product targets specific areas for weight loss (e.g., "Burn belly fat instantly!").
12. Using pseudoscientific terms or jargon to make the product sound more legitimate.
13. Falsely labeling a product as "FDA-approved" when it is not.
14. Failure to disclose the presence of stimulants, such as caffeine, in weight-loss supplements.
15. Hiding or understating the amount of added sugars or artificial sweeteners in the product.
16. Inaccurate claims about appetite suppression or hunger control.
17. Misleading information about the mechanism of action or the scientific basis behind the product's effectiveness.
18. Labeling a product as "all-natural" despite containing potentially harmful or synthetic ingredients.
19. Falsely claiming that the product is backed by scientific studies or clinical trials.
20. Using unproven or exaggerated claims about metabolism boosting or fat-burning properties.
21. Failing to disclose potential interactions with medications or health conditions.

Which New York laws govern labeling of weight-loss supplements?

In New York, the labeling of weight-loss supplements is regulated by both state and federal laws. The primary laws that govern the labeling of weight-loss supplements in New York include:

1. New York General Business Law (GBL): Section 399-ddd of the New York GBL establishes labeling requirements for weight-loss products sold in the state. This law mandates that weight-loss product labels include certain information, such as the manufacturer's name and address, a complete list of ingredients, and a statement of identity.
2. New York Code of Rules and Regulations (NYCRR): The NYCRR contains specific regulations regarding the labeling of dietary supplements, including weight-loss supplements. These regulations cover aspects such as the format and placement of label information, font size requirements, and specific labeling requirements for certain ingredients or claims.

Which federal law governs the labeling of weight-loss supplements?

On the federal level, weight-loss supplement labeling is primarily regulated by the Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act sets forth requirements for the labeling of all dietary supplements, including weight-loss supplements. Key provisions of the FD&C Act include:

1. Statement of Identity: The label must accurately identify the product as a dietary supplement and indicate the specific type of supplement it is (e.g., weight-loss supplement).
2. Nutrition Labeling: Weight-loss supplement labels must include a "Supplement Facts" panel that provides information about serving size, servings per container, and the amounts of various nutrients or dietary ingredients.
3. Ingredient List: The label must include a complete list of all ingredients used in the supplement, including the common or usual name of each ingredient and any known allergens.
4. Claims and Disclaimers: The FD&C Act regulates the claims that can be made on weight-loss supplement labels, requiring them to be truthful and not misleading. Certain claims, such as drug claims or disease treatment claims, may be subject to additional regulatory requirements.

Does the FDA Pre-Approve Dietary Supplements?

No, except as to those dietary supplements that make health claims, including those that relate to disease. We saw in Which Federal Agencies Govern False Advertising? (21 Useful FAQs that the FDA does not generally pre-approve dietary supplements making permissible structure-function claims. Many dietary supplements are marketed without even notifying the FDA.

Unlike prescription medications, the FDA does not subject dietary supplements to rigorous scientific analysis or clinical trials before the product is approved for consumer use.[19] Instead, the FDA intervenes to restrict or prohibit the sale of a supplement only after the agency receives well-documented reports of health risks associated with the product.[20]

Dietary supplements that make any “structure-function” claim, however, must notify the FDA per 21 C.F.R. § 101.93 no later than 30 days after the “first marketing of a dietary supplement.” Here is guidance how to notify the the FDA of structure-function claims.

Related Links on this Website:

• To understand whether federal law preempts state law on labeling of food, dietary supplements, or medications, click Does Federal Law "Preempt" (Block) State Lawsuits for Humane-Washing of Meat Labels?
• For an expansive look into humane-washing, click Is Humane-Washing of Meat and Poultry False Advertising?
• Learn about the 4 purposes of advertising, along with numerous common myths in false adverting.
• For a comprehensive review of New York law, click The Ultimate Guide to False-Advertising Law in New York: 22 FAQs.
• Click here to learn more about humane-washing, green-washing, and nutri-washing.
• Were you Misled?: Complete that form for a free legal analysis to determine if you were deceived by humane-washing or green-washing.
• A library of links relating to nutrition, animal welfare, and advertising law.

Related Links to FDA Guidance for Advertising on Dietary Supplements:

• Guidance for Substantiation of Advertising Claims on Supplements
• How to Notify the FDA of Structure-function Claims within 30 days
• Questions and Answers Relating to Health Claims in Dietary Supplements
• FTC: Dietary Supplement Advertising Guide

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