Q.01

What claims can dietary supplements make?

In the US, a dietary supplement can make four kinds of claim: structure/function statements (with the related general well-being and nutrient-deficiency statements), FDA-authorised health claims, qualified health claims, and nutrient content claims. What it cannot make is a disease claim, meaning one that it diagnoses, treats, cures, mitigates or prevents disease. If the label makes one, FDA regulates the product as a drug, unless the claim is an authorised health claim the product qualifies for [1]. In the EU, "food supplements" have no structure/function route: any health claim must be authorised and on the Union lists.

Approach: I worked from the current 21 CFR Part 101, FDA's lists of authorised health claims, qualified health claims and FDAMA claims, and FDA's structure/function claims page. For the EU I used Regulation (EC) No 1924/2006 and Directive 2002/46/EC. I did not research GB or other countries' rules for this answer.

United States (FD&C Act section 403(r) and 21 CFR 101)

1. Structure/function claims (21 CFR 101.93)

  • What they can say: a label "may" describe the role of a nutrient or dietary ingredient in affecting the structure or function of the human body. It may also describe the documented mechanism by which the ingredient maintains that structure or function, as long as the statement is not a disease claim [1].
  • Related statement types: FDA's page also covers statements about general well-being and statements about a benefit tied to a nutrient deficiency disease, such as vitamin C and scurvy (FDA, Structure/Function Claims).
  • Notification: the firm "shall" notify FDA no later than 30 days after first marketing. The notice gives the claim text, the ingredient and the product name [2][3].
  • Substantiation: a responsible person signs the notice and certifies that the firm has substantiation that the statement is truthful and not misleading [4].
  • Disclaimer wording: "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." A plural version is used when there are several claims [5][6].
  • Disclaimer format:
    • It goes next to the claim or is linked to it by a symbol such as an asterisk.
    • It must appear on every panel or page that carries a claim.
    • If it is not next to the claim, it is set off in a box [7].
    • It is in bold type at least 1/16 inch high [8].

2. Where the line falls: disease claims (101.93(g))

  • Definition of disease: damage to an organ or body system, or a state leading to that damage (for example hypertension). Essential nutrient deficiency diseases are excluded [9].
  • How FDA judges it: a statement is a disease claim if it suggests, explicitly or implicitly, an effect on a disease. FDA considers the context, and statements about maintaining healthy structure or function are not disease claims unless they imply prevention or treatment [10].
  • Statements that count as disease claims:
    • An effect on a specific disease, or on its characteristic signs or symptoms [11][12].
    • An effect on an abnormal condition linked to a natural state, if the condition is uncommon or can cause significant harm [13].
    • Being a substitute for a disease therapy, or augmenting a drug therapy [14][15].
    • Having a role in the body's response to a disease [16].
  • Implied disease claims also count. They can come from:
    • the product name [17];
    • naming a well-known drug ingredient in the formulation [18];
    • citations to publications that refer to a disease use [19];
    • pictures, vignettes or symbols [20].

3. Authorised health claims (21 CFR 101.14 and Subpart E)

  • Scope: these rules apply to food "regardless of whether the food is in conventional food form or dietary supplement form" [21].
  • What counts as a health claim: any express or implied link between a substance and a disease or health-related condition. Brand names like "heart" and heart symbols count [22].
  • When it is allowed: only if Subpart E provides for it and the product meets all of its conditions [23][24][25].
  • Disqualifying levels: the product must not exceed 13.0 g fat, 4.0 g saturated fat, 60 mg cholesterol or 480 mg sodium per reference amount [26][27].
  • Supplement exemption: supplements do not need the 10% of RDI/DRV natural nutrient content that conventional foods need [28].
  • Evidence standard: FDA authorises a claim only on "significant scientific agreement" [29].
  • FDA's list holds 12 approved categories:
    • Calcium, vitamin D and osteoporosis [30]
    • Dietary lipids (fat) and cancer [31]
    • Non-cariogenic carbohydrate sweeteners and dental caries [32]
    • Saturated fat and cholesterol and coronary heart disease (CHD) [33]
    • Fiber-containing grain products, fruits and vegetables and cancer [34]
    • Folic acid and neural tube defects [35]
    • Fruits and vegetables and cancer [36]
    • Fruits, vegetables and grain products containing fiber and CHD [37]
    • Sodium and hypertension [38]
    • Soluble fiber from certain foods and CHD [39]
    • Soy protein and CHD (FDA's entry also links a proposed revocation) [40]
    • Stanols/sterols and CHD [41]

4. Qualified health claims (FDA enforcement discretion)

  • FDA's list holds 40 enforcement-discretion letters. Some are repeats or update letters on the same topic.
  • Examples relevant to supplements include:
    • Cranberry dietary supplements and recurrent urinary tract infection in healthy women [42]
    • EPA/DHA and blood pressure [43]
    • Chromium picolinate and insulin resistance/type 2 diabetes [44]
    • Selenium and certain cancers [45]
    • Phosphatidylserine and cognitive dysfunction [46]
    • Magnesium and high blood pressure [47]
  • Each letter sets its own qualifying wording.
  • FDA also lists FDAMA claims based on authoritative statements. One is a linoleic acid nutrient content claim notification for "Foods and Dietary Supplements" [48].

5. Nutrient content claims

  • "High potency":
    • For a single vitamin or mineral, it must be at 100% or more of the RDI [49].
    • For a multi-ingredient product, it must have 100% or more of the RDI for at least two-thirds of the listed vitamins and minerals present at 2% or more of the RDI [50].
  • "Antioxidant": the named nutrients must have recognised antioxidant activity and meet the "high", "good source" or "more" levels. The nutrients must be named in the claim or linked to it by a symbol [51][52][53].
  • Percentage claims: supplements "may" make percentage claims for ingredients that have no RDI or DRV without a defining regulation [54].
    • The actual amount per serving "shall" appear next to the percentage, for example "40 percent omega-3 fatty acids, 10 mg per capsule" [55].
    • Comparative versions must identify the reference food and the amounts in both foods [56].
  • Calorie, fat, saturated fat and cholesterol claims: these may not be made on supplements that meet the "calorie free" or "low calorie" criteria. The exception is a calorie claim where a similar supplement it substitutes for normally exceeds "low calorie" [57].

EU (food supplements)

  • No disease claims: labelling, presentation and advertising "must not" attribute to a food supplement the property of preventing, treating or curing a human disease (Directive 2002/46/EC, Art. 6(2)) [58].
  • Prior authorisation: health claims "shall be prohibited" unless they are authorised and on the Article 13/14 lists (Reg. 1924/2006, Art. 10(1)) [59].
  • Mandatory accompanying information (Art. 10(2)):
    • the importance of a varied, balanced diet;
    • the quantity and pattern of consumption needed for the effect;
    • where appropriate, who should avoid the product;
    • a warning where excess intake is a risk.
  • General well-being wording (Art. 10(3)): non-specific benefits "may only" be mentioned alongside an authorised specific claim [59].
  • Article 13 function claims: cover body functions, psychological/behavioural functions and weight control. They must be based on generally accepted scientific evidence and be on the Union list [60].
  • Article 14 claims: disease risk reduction and children's development claims need individual authorisation. Risk reduction claims must also state that the disease has multiple risk factors [61].

The key difference: a US supplement can carry a self-substantiated structure/function claim with the FDA disclaimer and a 30-day notice. An EU food supplement can only use claim wording that has been authorised in advance. I can check a specific claim against the GB register, the EU lists or another country's register if useful.

Q.02

When do I need to notify the FDA?

For a structure/function claim, you notify FDA no later than 30 days after you first market a supplement carrying it. The notice comes after launch, not before, and no approval is needed [2]. A separate notice works the other way round: if the supplement contains a new dietary ingredient, you must notify FDA at least 75 days before you market it.

Approach: I used the current 21 CFR Part 101 (§101.93) and FDA's list of FDAMA claim notifications. I read 21 CFR 190.6 on eCFR because Part 190 is not in the datasets I can search.

1. Structure/function claims: 21 CFR 101.93(a), after launch

  • Who and when: the manufacturer, packer or distributor "shall notify" FDA's Office of Dietary Supplement Programs (HFS-810), CFSAN, 5001 Campus Dr., College Park, MD 20740. The deadline is no later than 30 days after first marketing a supplement that carries a section 403(r)(6) statement. You submit an original and two copies [2].
  • What the notice contains:
    • the name and address of the manufacturer, packer or distributor [62];
    • the exact text of the claim [63];
    • the dietary ingredient or supplement the claim is about, if the claim text does not already name it [64];
    • the product name, including the brand name [65].
  • Signature: a responsible individual signs the notice. They certify that it is complete and accurate, and that the firm has substantiation that the claim is truthful and not misleading [4].

2. New dietary ingredients: 21 CFR 190.6, before launch

  • When it applies: the supplement contains a new dietary ingredient that "has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered" (21 CFR 190.6(a), eCFR).
  • Who and when: the manufacturer or distributor of the supplement, or of the ingredient, "shall submit" the notice to the same FDA office at least 75 days before the product enters interstate commerce. You submit an original and two copies.
  • What the notice contains:
    • your name and address;
    • the ingredient's name, including the Latin binomial (with author) for botanicals;
    • the level of the ingredient and the conditions of use;
    • the history of use or other safety evidence, with copies of any cited references and English translations of foreign-language material;
    • a signature.
  • The waiting period:
    • The day FDA receives the notice is the filing date. For 75 days after it, you "shall not" introduce the product into interstate commerce (190.6(c)).
    • If you send a substantive amendment, FDA can assign a new filing date, which restarts the 75 days (190.6(d)).
    • FDA keeps the notice confidential for 90 days. After that it goes on public display, except trade secret or confidential commercial information (190.6(e)).
    • If FDA does not respond, that is not a finding that the ingredient is safe (190.6(f)).

3. Other claim types

  • Authorised health claims that you use as listed need no notice from you.
  • FDAMA claims: FDA's list of health and nutrient content claims based on an authoritative statement of a scientific body shows that these go through a notification route, with its own guidance (June 11, 1998). One example is the linoleic acid nutrient content claim notification for foods and dietary supplements (December 23, 2014) [48]. That list does not state how long before marketing the notice is due, so I have no deadline to give you for it.

If you tell me the ingredient and the claim wording, I can check whether a 101.93 notice, a 190.6 notice, or both apply.

Q.03

What does the FTC require for supplement advertising?

The FTC requires supplement advertising to be truthful and not misleading. You must have competent and reliable scientific evidence for every objective health or safety claim the ad communicates to reasonable consumers, whether the claim is stated or implied. That standard is set out in the FTC staff's Health Products Compliance Guidance, which replaced the 1998 staff guide Dietary Supplements: An Advertising Guide for Industry (FTC, Health Products Compliance Guidance). Endorsements and reviews in your marketing fall under the Endorsement Guides (16 CFR Part 255) and the Consumer Reviews and Testimonials Rule (16 CFR Part 465).

Approach: The regulatory datasets I can search hold no FTC advertising guidance or 16 CFR Parts 255 or 465, so this answer comes from FTC pages I opened on ftc.gov. I couldn't open the PDF versions of the guidance, the 2023 Endorsement Guides notice or the Part 465 Federal Register notice. The points below come from the FTC's web versions and press releases, so I don't quote individual section text from Parts 255 or 465.

1. Identify every claim the ad makes

  • Claims you are responsible for: you are responsible for every claim "suggested or reasonably implied" by the ad, not just the express wording.
  • Net impression: the FTC reads the ad as a whole, including the product name, charts, graphs and images.
  • Implied disease claims: a structure/function statement can also imply that the product treats a disease.
  • The FDA rules don't settle it: "FTC law makes no bright-line distinctions between categories of health-related products or claims." The DSHEA rules on structure/function claims in labeling "don't govern the FTC's assessment of those claims in advertising." Complying with 21 CFR 101.93 on the label is therefore not enough for the ad (FTC guidance).

2. Substantiation

  • Definition: competent and reliable scientific evidence means "tests, analyses, research, or studies" that experts in the field conducted and evaluated objectively, using methods "generally accepted in the profession to yield accurate and reliable results."
  • Type of evidence:
    • Randomized, controlled human clinical trials (RCTs) "are generally the type of substantiation that experts would require for health benefit claims."
    • Animal and in vitro studies are not sufficient without confirming human RCTs.
    • Consumer anecdotes "are never sufficient."
    • Epidemiological evidence is acceptable only where experts accept it in place of RCTs and RCTs are not feasible.
  • Study quality: the guidance looks for:
    • a control group, randomization and double blinding;
    • results that are statistically significant and also clinically meaningful;
    • reporting of all outcomes;
    • no reliance on post hoc analyses.
  • Totality of evidence: you must consider "all relevant well-conducted research," not only the studies that support you. Your evidence should be "largely consistent with the surrounding body of evidence."
  • Fit to your product: check dose, formulation, ingredient identity, route of administration, outcome measures and study population against your actual product. Don't exaggerate "the extent, nature, or permanence" of the effects a study found (FTC guidance).

3. Disclosures and qualifiers

  • When a disclosure is needed: you must disclose significant limitations on a claimed benefit and significant safety risks of customary use, such as side effects and drug interactions.
  • Clear and conspicuous: a disclosure must be "difficult to miss … and easily understandable by ordinary consumers." In particular:
    • a claim made both on screen and in audio needs the disclosure in both;
    • online, the disclosure "should be unavoidable," and hyperlinked disclosures are "avoidable."
  • Disclaimers can't fix a deceptive claim:
    • A disclaimer "cannot directly contradict a claim."
    • Words like "may," "helps," "promising" or "preliminary" don't adequately convey that the science is only emerging.
    • "The DSHEA disclaimer or similar statements won't cure an otherwise deceptive ad" (FTC guidance).

4. Claims about FDA status and traditional use

  • FDA status: complying with DSHEA "doesn't constitute FDA authorization." You shouldn't imply that FDA approved a structure/function claim, or describe a qualified health claim as full approval.
  • Traditional use claims:
    • Identify the traditional use and make sure your product is consistent with it.
    • State the lack of scientific evidence in a prominent disclosure next to the claim, and don't undercut it with endorsements or images.
    • Don't make traditional use claims about treating serious conditions at all, "even if the claim is carefully qualified" (FTC guidance).

5. Testimonials, experts and influencers

  • Same standard as your own claims: you can't make a claim through a testimonial or expert that you couldn't substantiate yourself. You also need evidence that the product will work for buyers as it did for the endorser.
  • Atypical results: testimonials showing results more dramatic than users can generally expect are likely deceptive, and "Results not typical" doesn't cure that.
  • Expert endorsers: they must be qualified, and they must have examined or tested the product in a way generally recognized in the field.
  • Material connections: any personal, financial or similar connection consumers wouldn't expect must be clearly and conspicuously disclosed (FTC guidance).
  • Endorsement Guides (16 CFR 255), revised June 29, 2023: the FTC's announcement lists these changes:
    • a new principle on procuring, suppressing, boosting or editing consumer reviews;
    • expanded coverage of incentivized, employee and fake reviews;
    • a formal definition of "clear and conspicuous," noting that a platform's built-in disclosure tool "might not be an adequate disclosure";
    • an endorsement definition that covers fake reviews, virtual influencers and social media tags;
    • clearer liability for advertisers, endorsers and intermediaries;
    • child-directed advertising flagged as an area of special concern (FTC press release, June 2023; FTC, Endorsements, Influencers, and Reviews).

6. Consumer Reviews and Testimonials Rule (16 CFR 465)

The rule was announced August 14, 2024 and took effect 60 days after publication in the Federal Register. It prohibits:

  • fake or false consumer reviews, consumer testimonials and celebrity testimonials;
  • paying or otherwise rewarding reviewers on condition that the review is positive or negative;
  • insider reviews and testimonials that don't disclose the insider's connection to the business;
  • company-controlled review websites presented as independent;
  • suppressing reviews through threats or false accusations;
  • buying or selling fake social media indicators, such as bot-generated followers.

Unlike the Guides, this is a trade regulation rule. The FTC can "seek civil penalties against knowing violators" (FTC press release, Aug 2024).

7. Who is liable

"Anyone participating in deceptive marketing is potentially liable." The FTC has acted against product marketers and against owners and corporate officers, ad agencies, distributors, retailers, infomercial producers and expert endorsers (FTC guidance).

FDA governs what goes on the label: the 101.93 notice and disclaimer we discussed earlier. The FTC governs the ad, and in practice it expects human RCT-level support for health benefit claims, whatever the label disclaimer says. If you share draft ad copy, I can go through which express and implied claims it makes and what support each would need.

Q.04