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Academy · Course 10 Statute and regulation Explorers

A supplement that claims to treat a disease is legally a drug, so botanical supplements describe structure or function instead

U.S. law defines a drug by its intended use, and a label claim is evidence of that use. Read the statute and FDA's rule, then sort FDA's own 22 examples yourself.

Level
Introductory to intermediate
Reading time
About 25 minutes
Builds on
Legal status of botanicals
Tools
Claim sorter, criteria checker, 1 sunburst, 1 heat map
10criteria in 21 CFR 101.93(g)(2) that make a statement a disease claim
30days after first marketing to notify FDA of a structure/function statement
20%of 127 sampled supplements carried prohibited disease claims (HHS OIG, 2012)
4botanical drugs approved by FDA, the only route to a treatment claim

Not legal advice. This course explains published law and FDA's examples as of October 23, 2026. Claim decisions belong to qualified regulatory counsel. EUTECNIQ Sciences is a company in formation and makes no product claims.

At a glance · Intended use

The law classifies by intended use, so one extract can be a supplement, a food with a health claim or a drug

Psyllium husk, four kinds of statement, three legal categoriesStatute and regulation
One ingredient, psyllium husk, and four kinds of statement: a structure/function statement keeps it a supplement; an authorized or a qualified health claim keeps it a food or supplement; a disease claim makes it a drugSame ingredientWhat the label saysLegal category and conditionPsyllium huskseed coat of PlantagoovataStructure/function statementDescribes an effect on the body's structure or functionDietary supplement§ 403(r)(6): substantiation, notice to FDA within30 days, disclaimerAuthorized health claim21 CFR 101.81: soluble fiber from psyllium husk andcoronary heart diseaseFood or supplementNot a drug “solely because” of the claim,§ 201(g)(1)Qualified health claimFDA letter of June 24, 2014: psyllium husk and type 2diabetesFood or supplementOnly with the qualifying language in FDA's letterof enforcement discretionClaim to treat or prevent a diseaseMeets a criterion of 21 CFR 101.93(g)(2) and is not anauthorized health claimDrug§ 201(g)(1)(B); needs an approved application,§ 505(a)Psyllium husk with four kinds of statement and the legal category each producesPsyllium huskseed coat of Plantago ovataStructure/function statementDescribes an effect on the body's structure or functionDietary supplement§ 403(r)(6): substantiation, notice to FDA within 30days, disclaimerAuthorized health claim21 CFR 101.81: soluble fiber from psyllium husk andcoronary heart diseaseFood or supplementNot a drug “solely because” of the claim, § 201(g)(1)Qualified health claimFDA letter of June 24, 2014: psyllium husk and type 2diabetesFood or supplementOnly with the qualifying language in FDA's letter ofenforcement discretionClaim to treat or prevent a diseaseMeets a criterion of 21 CFR 101.93(g)(2) and is not anauthorized health claimDrug§ 201(g)(1)(B); needs an approved application,§ 505(a)
21 U.S.C. 321(g)(1) and 343(r)(6); 21 CFR 101.81(c)(2) (7 g or more per day of soluble fiber from psyllium seed husk); FDA, qualified health claim letter on psyllium husk and type 2 diabetes, June 24, 2014; 21 CFR 101.93(f).
Explanation, details and sources

A drug includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body” (§ 201(g)(1)(B), (C)). A supplement making a compliant § 403(r)(6) statement “is not a drug under clause (C) solely because” of it.

You will learn

  1. Quote the statutory definition of a drug and explain why intended use, not the plant, decides the category.
  2. State the three conditions on a structure/function statement and the exact disclaimer.
  3. Apply the ten disease-claim criteria of 21 CFR 101.93(g)(2) to FDA's own examples.
  4. Distinguish authorized health claims, qualified health claims and drug claims by their evidence standards.
  5. Recognize the chain of violations in a disease-claim warning letter.
  6. Outline the botanical drug pathway and name the four approved botanical drugs.
History

Each statute since 1906 added a requirement, and DSHEA in 1994 created the structure/function route

Twelve dated steps from the 1906 Food and Drugs Act to FDA's 2026 NDI guidanceStatute and regulation
Timeline of U.S. law on drug and supplement claims from the 1906 Food and Drugs Act to FDA's October 2026 NDI guidance, with a broken axis between 1970 and 1985June 30, 1906: Food and Drugs ActJune 30, 1906Food and Drugs Actmisbranded andadulterated drugsJune 25, 1938: FD&C ActJune 25, 1938FD&C Actnew drugs shownsafe before marketingOctober 10, 1962: Kefauver–HarrisOctober 10, 1962Kefauver–Harriseffectiveness provenbefore marketingNovember 8, 1990: NLEANovember 8, 1990NLEAhealth claims forfoodsOctober 25, 1994: DSHEAOctober 25, 1994DSHEAdietary supplements;§ 403(r)(6)1999: Pearson v. Shalala1999Pearson v. Shalalaqualified healthclaimsJanuary 6, 2000: Structure/function ruleJanuary 6, 2000Structure/functionrule65 FR 10002006: Veregen approved2006Veregen approvedand serious adverseevent reporting lawJanuary 4, 2011: FSMAJanuary 4, 2011FSMA§ 113, new dietaryingredientsDecember 2016: Botanical drug guidanceDecember 2016Botanical drugguidanceRevision 1December 20, 2022: FTC guidanceDecember 20, 2022FTC guidancehealth productsOctober 19, 2026: NDI final guidanceOctober 19, 2026NDI final guidanceidentity and safety1900192519501970198519952005201520252030Timeline of U.S. law on drug and supplement claims, 1906 to 20261906Food and Drugs ActJune 30, 1906: misbranded and adulterateddrugs1938FD&C ActJune 25, 1938: new drugs shown safebefore marketing1962Kefauver–HarrisOctober 10, 1962: effectiveness provenbefore marketing1990NLEANovember 8, 1990: health claims for foods1994DSHEAOctober 25, 1994: dietary supplements;§ 403(r)(6)1999Pearson v. Shalalaqualified health claims2000Structure/function ruleJanuary 6, 2000: 65 FR 10002006Veregen approvedand serious adverse event reporting law2011FSMAJanuary 4, 2011: § 113, new dietaryingredients2016Botanical drug guidanceRevision 12022FTC guidanceDecember 20, 2022: health products2026NDI final guidanceOctober 19, 2026: identity and safety
FDA, Milestones in U.S. Food and Drug Law; 52 Stat. 1040; Pub. L. 87-781; Pub. L. 101-535; Pub. L. 103-417; 164 F.3d 650 (D.C. Cir. 1999); 65 FR 1000; Drugs@FDA; Pub. L. 109-462; Pub. L. 111-353; FDA botanical guidance (2016); FTC (2022); 91 FR 66336.
Text version of the timeline
  • June 30, 1906: Food and Drugs Act. June 25, 1938: FD&C Act; new drugs shown safe before marketing.
  • October 10, 1962: Kefauver–Harris amendments; effectiveness proven before marketing.
  • November 8, 1990: Nutrition Labeling and Education Act. October 25, 1994: Dietary Supplement Health and Education Act.
  • 1999: Pearson v. Shalala, 164 F.3d 650. January 6, 2000: structure/function final rule, 65 FR 1000, effective February 7, 2000.
  • 2006: Veregen approved October 31; serious adverse event reporting law signed December 22 (Pub. L. 109-462).
  • January 4, 2011: FDA Food Safety Modernization Act, § 113 on new dietary ingredients (passed by Congress December 21, 2010).
  • December 2016: Botanical Drug Development guidance, Revision 1. December 20, 2022: FTC Health Products Compliance Guidance. October 19, 2026: FDA final guidance on NDI identity and safety information.
Explanation, details and sources

The 1938 Act required new drugs to be shown safe before marketing; the 1962 amendments added proof of effectiveness. The 1990 NLEA authorized health claims for foods, and DSHEA defined dietary supplements and their statements.

Structure/function statements

A structure/function statement needs substantiation, a notice to FDA within 30 days and a fixed disclaimer

30 daysAfter first marketing, the latest date to notify FDA of the statement (21 CFR 101.93(a)(1))
1/16 inchSmallest letter size for the boldface disclaimer (21 CFR 101.93(e))
≈3,690Notifications FDA expects each year, at about 45 minutes each (90 FR 35694, 2025)
What a compliant label carries, and what the firm must hold off the labelStatute and regulation
Schematic supplement label: a structure/function statement ending in an asterisk, and the boxed boldface disclaimer linked by the same symbol, with the requirements of 21 CFR 101.93(a), (c), (d) and (e) and section 403(r)(6)(B)Product name and statement of identityStructure/function statement*describes an effect on the structure orfunction of the body; names no disease(placeholder, not real claim text)*This statement has not been evaluated by the Foodand Drug Administration. This product is not intendedto diagnose, treat, cure, or prevent any disease.Supplement Facts panelStatement, § 403(r)(6)(A)may not claim to diagnose, mitigate, treat, cure, or prevent a specific diseaseor class of diseasesText and placement, 101.93(c), (d)singular or plural wording; adjacent, or linked by a symbol; in a box when notadjacent; on each panel with a statementType, 101.93(e)boldface, letters no smaller than one-sixteenth inchOff the label, 403(r)(6)(B) and 101.93(a)the firm holds substantiation; it notifies FDA no later than 30 days after firstmarketing
21 U.S.C. 343(r)(6); 21 CFR 101.93(a)–(e) (eCFR, current to October 21, 2026). Schematic; not a real label.
Explanation, details and sources

The statement “may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases” (§ 403(r)(6)). The disclaimer reads: “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.” (21 CFR 101.93(c)(1)).

Disease claims

FDA's 2000 rule lists ten ways a statement becomes a disease claim, and context can decide

The ten criteria of 21 CFR 101.93(g)(2), with an example FDA published for seven of themRegulation FDA examples
Grid of the ten disease-claim criteria of 21 CFR 101.93(g)(2), each with an example FDA published(i)Has an effect on a specific disease or class of diseases“Protective against the development of cancer” · 65 FR 1012(ii)Has an effect on the characteristic signs or symptoms of aspecific disease or class of diseases“Inhibits platelet aggregation” · 65 FR 1016(iii)Has an effect on an abnormal condition associated with anatural state or process, if uncommon or able to causesignificant or permanent harm“Alzheimer's disease, and other senile dementias” · 65 FR 1020(iv)Has an effect on a disease through the product name,formulation, a citation, the term “disease,” or pictures andsymbols“CarpalHealth” (a product name) · 65 FR 1022(v)Belongs to a class of products intended to diagnose, mitigate,treat, cure, or prevent a disease“antidepressant” · 65 FR 1026(vi)Is a substitute for a product that is a therapy for a diseaseNo quoted example in the rule's text we use(vii)Augments a particular therapy or drug action intended for adiseaseNo quoted example in the rule's text we use(viii)Has a role in the body's response to a disease or to a vector ofdisease“supports the body's antiviral capabilities” · 65 FR 1028(ix)Treats, prevents, or mitigates adverse events of a therapy, ifthe adverse events are diseases“to maintain the intestinal flora in people on antibiotics” · SECG,criterion 9(x)Otherwise suggests an effect on a disease or diseasesCatch-all for implied claims the other nine missThe ten disease-claim criteria of 21 CFR 101.93(g)(2), each with an example FDA published(i)Has an effect on a specific disease or classof diseases“Protective against the development of cancer” ·65 FR 1012(ii)Has an effect on the characteristic signs orsymptoms of a specific disease or class ofdiseases“Inhibits platelet aggregation” · 65 FR 1016(iii)Has an effect on an abnormal conditionassociated with a natural state or process, ifuncommon or able to cause significant orpermanent harm“Alzheimer's disease, and other seniledementias” · 65 FR 1020(iv)Has an effect on a disease through theproduct name, formulation, a citation, theterm “disease,” or pictures and symbols“CarpalHealth” (a product name) · 65 FR 1022(v)Belongs to a class of products intended todiagnose, mitigate, treat, cure, or prevent adisease“antidepressant” · 65 FR 1026(vi)Is a substitute for a product that is a therapyfor a diseaseNo quoted example in the rule's text we use(vii)Augments a particular therapy or drugaction intended for a diseaseNo quoted example in the rule's text we use(viii)Has a role in the body's response to adisease or to a vector of disease“supports the body's antiviral capabilities” · 65FR 1028(ix)Treats, prevents, or mitigates adverseevents of a therapy, if the adverse eventsare diseases“to maintain the intestinal flora in people onantibiotics” · SECG, criterion 9(x)Otherwise suggests an effect on a diseaseor diseasesCatch-all for implied claims the other nine miss
21 CFR 101.93(g)(2) (criteria abridged); examples quoted from the preamble, 65 FR 1000 (January 6, 2000), at the page shown, and FDA, Small Entity Compliance Guide on Structure/Function Claims (SECG, January 2002).

Sort FDA's own examples FDA examples, verbatim

Classify each of FDA's 22 examples, then compare with FDAFDA examples, verbatim
Answered0 of 22
Matching FDA0
Scoren/a

  1. “protective against the development of cancer”

    FDA: disease claim, criterion (i), a specific disease. 65 FR 1012; SECG criterion 1.

  2. “Helps promote urinary tract health”

    FDA: structure/function; no specific disease state. 65 FR 1012.

  3. “reduces the pain and stiffness associated with arthritis”

    FDA: disease claim, criterion (i). 65 FR 1012; SECG criterion 1.

  4. “inhibits platelet aggregation”

    FDA: implied disease claim, criterion (ii); inhibiting platelet aggregation “is a well-recognized therapy for the prevention of stroke and recurrent heart attack.” FDA reversed its 1998 proposal here. 65 FR 1016.

  5. “For relief of occasional constipation”

    FDA: “would therefore not be considered a disease claim,” though labeling should exclude chronic constipation. 65 FR 1015.

  6. “decreases the effects of alcohol intoxication”

    FDA: disease claim, criterion (i); intoxication “meets the definition of disease, albeit a transient disease.” 65 FR 1012, 1015.

  7. “helps to maintain cholesterol levels that are already within the normal range”

    FDA: “an appropriate structure/function claim.” 65 FR 1019.

  8. “lowers cholesterol”

    FDA: “however qualified, is an implied disease claim,” criterion (ii). 65 FR 1019.

  9. A claim about “hot flashes”

    FDA: on its list of natural-state conditions about which structure/function claims could be made, criterion (iii). 65 FR 1020.

  10. A claim about “severe depression associated with the menstrual cycle”

    FDA: remains a disease claim, criterion (iii). 65 FR 1020; SECG criterion 3.

  11. “CarpalHealth” (a product name)

    FDA: implied claim for carpal tunnel syndrome through the name, criterion (iv)(A). 65 FR 1022; SECG criterion 4.

  12. “Soothing Sleep” (a product name)

    FDA: could be a claim to treat insomnia “unless other context in the labeling makes clear that the claim relates to a non-disease condition, such as occasional sleeplessness.” SECG criterion 4; 65 FR 1022.

  13. “Promotes good health and prevents the onset of disease”

    FDA: disease claim, criterion (iv)(D), because it implies the product itself prevents disease; “a good diet promotes good health and prevents the onset of disease” is acceptable. 65 FR 1025; SECG.

  14. “antidepressant” (a product class)

    FDA: a class name tied to disease treatment, criterion (v). 65 FR 1026; SECG criterion 5.

  15. “diuretic that relieves temporary water-weight gain”

    FDA: “an appropriate product claim,” because the context limits it to structure/function. SECG criterion 5.

  16. “supports the body's antiviral capabilities”

    FDA: disease claim, criterion (viii), the body's response to disease. 65 FR 1028; SECG criterion 8.

  17. “supports the immune system”

    FDA: “not specific enough to imply prevention of disease.” SECG criterion 8; 65 FR 1029.

  18. “to maintain the intestinal flora in people on antibiotics”

    FDA: disease claim, criterion (ix), implying prevention of overgrowth after antibiotic therapy. SECG criterion 9.

  19. “helps maintain cardiovascular function and a healthy circulatory system”

    FDA: structure/function; no specific disease state. 65 FR 1012.

  20. “Relieves crushing chest pain”

    FDA: implied disease claim for “angina or heart attack,” criterion (i). 65 FR 1013; SECG criterion 1.

  21. “improves absentmindedness”

    FDA: an appropriate structure/function claim “if there is no context linking them to a disease.” SECG criterion 2; 65 FR 1016.

  22. “promotes relaxation”

    FDA: structure/function; no specific disease state. 65 FR 1012.

Method, assumptions and limits
What it does
Compares your classification of 22 statements with FDA's own classification and counts the matches. Score = matches ÷ statements answered.
Source of every statement
Each statement is quoted verbatim from the preamble to FDA's final rule, 65 FR 1000 (January 6, 2000), at the page given, or from FDA's Small Entity Compliance Guide on Structure/Function Claims (SECG, January 2002). Capitalization follows the source.
Assumptions
Each statement is read without other labeling. Where FDA said context decides, the answer is “Depends on context.”
What it does not establish
It does not classify new wording. FDA reads each claim in the context of the whole label and labeling, and FTC substantiation rules apply separately.
Verification
The answer key is checked against an independent Python key written from the FDA texts (tests/numerics/ref/academy_why-no-disease-claims.py).
FDA's answers, grouped: 12 disease claims, 8 structure/function claims and 2 that depend on contextFDA examples; short labels
The 22 statements and FDA's classification in the sorter above, from the final rule 65 FR 1000 (January 6, 2000) and FDA's 2002 Small Entity Compliance Guide. Segment labels are short keywords; hover or focus a segment to read FDA's exact wording, which is also listed in the sorter above. Select a ring to zoom. Documented cases of products that claimed to treat disease: Lessons learned.
Explanation, details and sources

A disease is “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension)”; nutrient-deficiency diseases are excluded (21 CFR 101.93(g)(1)). FDA “will consider the context in which the claim is presented.”

Natural states

Conditions of pregnancy, menstruation, menopause and aging are disease claims only when uncommon or harmful

FDA's ten conditions open to structure/function claims, and nine that remain disease claimsFDA final rule preamble
Two lists from FDA's 2000 rule: ten conditions of pregnancy, the menstrual cycle, menopause and aging about which structure/function claims may be made, and nine that remain disease claimsStructure/function claims may be made aboutMorning sickness associated with pregnancyLeg edema associated with pregnancyMild mood changes, cramps, and edema associated with themenstrual cycleHot flashesWrinklesOther signs of aging on the skin, e.g., liver spots, spider veinsPresbyopia associated with agingMild memory problems associated with agingHair loss associated with agingNoncystic acneClaims about these remain disease claimsToxemia of pregnancyHyperemesis gravidarumAcute psychosis of pregnancyOsteoporosisAlzheimer's disease, and other senile dementiasGlaucomaArteriosclerotic diseases of coronary, cerebral or peripheral bloodvesselsCystic acneSevere depression associated with the menstrual cycleFDA's lists of natural-state conditions: ten open to structure/function claims and nine that remain disease claimsStructure/function claims may be made aboutMorning sickness associated with pregnancyLeg edema associated with pregnancyMild mood changes, cramps, and edema associatedwith the menstrual cycleHot flashesWrinklesOther signs of aging on the skin, e.g., liver spots,spider veinsPresbyopia associated with agingMild memory problems associated with agingHair loss associated with agingNoncystic acneClaims about these remain disease claimsToxemia of pregnancyHyperemesis gravidarumAcute psychosis of pregnancyOsteoporosisAlzheimer's disease, and other senile dementiasGlaucomaArteriosclerotic diseases of coronary, cerebral orperipheral blood vesselsCystic acneSevere depression associated with the menstrualcycle
65 FR 1000, at 1020 (lists quoted in full). FDA put benign prostatic hypertrophy on neither list.

Check a claim against the ten criteria Educational logic

The statement, in its context…
Criteria met0
Natural-state testNot used
ResultNo criterion met

No criterion is met by the features chosen. The statement could be a structure/function statement if it is substantiated, notified within 30 days and carries the disclaimer; context can still change that.

Criteria of 21 CFR 101.93(g)(2) met by the statement describedEducational logic
  1. (i) Has an effect on a specific disease or class of diseases; Not met
  2. (ii) Has an effect on the characteristic signs or symptoms of a specific disease or class of diseases, using scientific or lay terminology; Not met
  3. (iii) Has an effect on an abnormal condition associated with a natural state or process, if the abnormal condition is uncommon or can cause significant or permanent harm; Not met
  4. (iv) Has an effect on a disease or diseases through one or more of the following factors: (A) The name of the product; (B) A statement about the formulation of the product …; (C) Citation of a publication or reference …; (D) Use of the term “disease” or “diseased” …; or (E) Use of pictures, vignettes, symbols, or other means; Not met
  5. (v) Belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease; Not met
  6. (vi) Is a substitute for a product that is a therapy for a disease; Not met
  7. (vii) Augments a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent a disease or class of diseases; Not met
  8. (viii) Has a role in the body's response to a disease or to a vector of disease; Not met
  9. (ix) Treats, prevents, or mitigates adverse events associated with a therapy for a disease, if the adverse events constitute diseases; or Not met
  10. (x) Otherwise suggests an effect on a disease or diseases. Not met
Criteria quoted from 21 CFR 101.93(g)(2); ellipses shorten (iv)(B) to (D).
Method, assumptions and limits
What it calculates
Which of the ten criteria of 21 CFR 101.93(g)(2) a statement meets, given the features you tick, and how many.
Rule for criterion (iii)
Met when a natural state is chosen and the condition is uncommon (share < 50%) or can cause significant or permanent harm. The 50% line is FDA's “fewer than one-half” (SECG, criterion 3).
Variables and units
Share: percent of people in the stage or process, 0–100. Criterion (iv) counts once, whichever of its five factors applies.
What it does not establish
You decide whether each feature is present; FDA decides from the whole label and labeling. A statement that meets no criterion still needs substantiation, notification and the disclaimer, and must not be misleading. Not legal advice.
Verification
Seven feature sets are checked against an independent Python implementation (tests/numerics/ref/academy_why-no-disease-claims.py) and by unit tests.
Explanation, details and sources

FDA's test for criterion (iii): “a condition is uncommon if it occurs in fewer than one-half of those experiencing that stage or process,” and it can cause significant or permanent harm “if it must be treated effectively to prevent that harm and for which effective treatments are available” (SECG).

Health claims

Health claims are a separate, pre-cleared route, and only twelve are codified

The twelve authorized health claims cover six diseases; six name a plant or plant-derived sourceRegulation
The twelve authorized health claims of 21 CFR 101.72 to 101.83, grouped by disease: five for coronary heart disease, three for cancer, and one each for osteoporosis, hypertension, neural tube defects and dental caries; six name a plant or plant-derived sourceCoronary heart disease · 5101.75Dietary saturated fat and cholesterol101.77Fruits, vegetables and grain products that contain fiber,particularly soluble fiber101.81Soluble fiber from certain foods (oat, barley, psyllium husk)101.82Soy protein101.83Plant sterol/stanol estersOsteoporosis · 1101.72Calcium, vitamin DHypertension · 1101.74SodiumCancer · 3101.73Dietary lipids101.76Fiber-containing grain products, fruits, and vegetables101.78Fruits and vegetablesNeural tube defects · 1101.79FolateDental caries · 1101.80Dietary noncariogenic carbohydrate sweetenersSection title or text names a plant or plant-derived source
21 CFR 101.72–101.83, section titles (eCFR, current to October 21, 2026).
Four questions decide where a statement about health landsStatute and regulation
Four questions decide where a label statement about health lands: structure/function statement, authorized health claim, qualified health claim, or unapproved new drugQuestion about the statementConsequence of the answer on the arrow1Does the statement claim, explicitly or implicitly, an effecton a disease?Any criterion of 21 CFR 101.93(g)(2), read in contextStructure/function statementSubstantiation, notice to FDA within 30 days,disclaimer; § 403(r)(6)NoStatute and regulation2Is it an authorized health claim for which the productqualifies?21 CFR 101.72 to 101.83Authorized health claimAllowed on a food or supplement; not a drug solelybecause of the claimYesRegulation3Does an FDA letter of enforcement discretion cover theclaim and its wording?Qualified health claimsQualified health claimOnly with the qualifying language in FDA's letterYesFDA letters4Is the product approved for that use under a new drugapplication?§ 505(a); 21 CFR 101.93(f)Unapproved new drug and misbrandedThe violations FDA cites in disease-claim warninglettersNoStatuteFour questions decide where a label statement about health lands: structure/function statement, authorized health claim, qualified health claim, or unapproved new drug1Does the statement claim, explicitly orimplicitly, an effect on a disease?Any criterion of 21 CFR 101.93(g)(2), read in contextStructure/function statementSubstantiation, notice to FDA within 30 days,disclaimer; § 403(r)(6)No · Statute and regulation2Is it an authorized health claim for which theproduct qualifies?21 CFR 101.72 to 101.83Authorized health claimAllowed on a food or supplement; not a drug solelybecause of the claimYes · Regulation3Does an FDA letter of enforcement discretioncover the claim and its wording?Qualified health claimsQualified health claimOnly with the qualifying language in FDA's letterYes · FDA letters4Is the product approved for that use under anew drug application?§ 505(a); 21 CFR 101.93(f)Unapproved new drug and misbrandedThe violations FDA cites in disease-claim warninglettersNo · Statute
21 CFR 101.93(f), (g); 21 CFR 101.14 and 101.72–101.83; FD&C Act §§ 403(r)(6), 505(a).
FDA's qualified health claim list has 40 entries since 2000, seven with a plant-derived subjectFDA data
Bars of entries on FDA's list of qualified health claim letters by year, 2000 to 2024, 40 in all; copper segments mark plant-derived subjects: tomatoes 2005, green tea 2011 and its 2012 update, psyllium husk 2014, cranberry 2020, cocoa flavanols 20230246Entries per year2000: 2 other entries20002001: 2 other entries2003: 6 other entries2004: 5 other entries2005: 3 other entries2005: Tomatoes (2)20052006: 1 other entries2007: 1 other entries2009: 2 other entries20102011: 1 other entries2011: Green tea2012: Green tea update2013: 1 other entries2014: Psyllium husk20152016: 1 other entries2017: 3 other entries2018: 1 other entries2019: 1 other entries2020: 1 other entries2020: Cranberry20202022: 1 other entries2023: Cocoa flavanols2024: 1 other entries2024Tomatoes (2)Psyllium huskCranberryCocoa flavanolsGreen tea and its updatePlant-derived subjectOther subjects
FDA, Qualified Health Claims: Letters of Enforcement Discretion (content current as of March 28, 2024), counted by letter year; includes three updating letters and one settlement notice. Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), as described in 77 FR 4329 (2012).
Data: qualified health claim entries by year

2000: 2 · 2001: 2 · 2003: 6 · 2004: 5 · 2005: 5 · 2006: 1 · 2007: 1 · 2009: 2 · 2011: 2 · 2012: 1 · 2013: 1 · 2014: 1 · 2016: 1 · 2017: 3 · 2018: 1 · 2019: 1 · 2020: 2 · 2022: 1 · 2023: 1 · 2024: 1 (total 40). Plant-derived subjects: tomatoes (two letters, 2005), green tea (2011) and its update (2012), psyllium husk (2014), cranberry juice and cranberry supplements (2020), cocoa flavanols (2023).

Text version of the decision ladder: a statement with no disease effect is a structure/function statement; one with a disease effect is lawful on a food or supplement only as an authorized health claim the product qualifies for, or as a qualified health claim with FDA's wording; otherwise the product is an unapproved new drug unless approved for that use.

Explanation, details and sources

FDA authorizes a health claim only when there is “significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence” (21 CFR 101.14(c)). Psyllium is one botanical example: its husk must be at least 95% pure by USP methods (101.81(c)(2)(ii)(B)).

Evidence standards

Each claim type carries a different evidence standard, and the FTC applies its own to all advertising

Five claim types, what each needs before use, and who weighs the evidenceStatute and regulation
Matrix of five claim types against what is needed before use, the evidence standard in the source's words, and who weighs the evidenceBefore useEvidence standard, in the source's wordsWho weighs the evidenceStructure/functionstatementNone; notify FDA within 30 daysafter first marketingthe manufacturer “has substantiation that suchstatement is truthful and not misleading”(§ 403(r)(6)(B))The firm; FDA doesnot review before useAuthorized health claimAn FDA regulation (petition under 21CFR 101.70)“significant scientific agreement” (21 CFR 101.14(c))FDAQualified health claimAn FDA letter of enforcementdiscretionclaims “backed by credible scientific evidence,” withqualifying language (FDA, 77 FR 4329)FDADrug claimApproval of an NDA or BLA“substantial evidence … adequate and well-controlledinvestigations” (§ 505(d))FDA (CDER)Any advertising claimNone“competent and reliable scientific evidence” (FTC,December 2022)FTC, after the factFive claim types, what is needed before use, the evidence standard and who weighs itStructure/function statementNone; notify FDA within 30 days after first marketingthe manufacturer “has substantiation that such statementis truthful and not misleading” (§ 403(r)(6)(B))The firm; FDA does not review before useAuthorized health claimAn FDA regulation (petition under 21 CFR 101.70)“significant scientific agreement” (21 CFR 101.14(c))FDAQualified health claimAn FDA letter of enforcement discretionclaims “backed by credible scientific evidence,” withqualifying language (FDA, 77 FR 4329)FDADrug claimApproval of an NDA or BLA“substantial evidence … adequate and well-controlledinvestigations” (§ 505(d))FDA (CDER)Any advertising claimNone“competent and reliable scientific evidence” (FTC,December 2022)FTC, after the fact
21 U.S.C. 343(r)(6)(B); 21 CFR 101.14(c) and 101.70; 77 FR 4329 (2012); 21 U.S.C. 355(d); FTC, Health Products Compliance Guidance (December 2022).
In the Inspector General's sample, 20% of labels made disease claims and none of 557 human studies met all of FDA's evidence recommendationsHHS OIG report
Bars from the HHS Inspector General's 2012 review of 127 supplements: 20 percent bore prohibited disease claims and 7 percent lacked the disclaimer; of 557 human studies submitted as substantiation, 98 percent did not study the actual product, 85 percent were not randomized double-blind placebo-controlled parallel trials, 49 percent used unlike populations, 34 percent focused on disease research and 4 percent contradicted the claim127 supplements sampled for weight loss or immune supportLabels with prohibited disease claimsLabels with prohibited disease claims: 20% (26 of 127 supplements)20%Labels missing the required disclaimerLabels missing the required disclaimer: 7% (9 of 127)7%557 human studies among 1,624 substantiation documentsDid not study the actual productDid not study the actual product: 98% (of 557 human studies)98%Not randomized, double-blind, parallel, placebo-controlledNot randomized, double-blind, parallel, placebo-controlled: 85% (of 557)85%Population unlike the intended usersPopulation unlike the intended users: 49% (of 557)49%Focused on disease researchFocused on disease research: 34% (189 of 557)34%Contradicted the claimContradicted the claim: 4% (20 of 557)4%
HHS Office of Inspector General. Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements. OEI-01-11-00210, October 2, 2012.
Data: Inspector General findings

127 supplements with 378 structure/function claims. 26 (20%) had prohibited disease claims; 9 (7%) lacked the disclaimer. 66 of 104 manufacturers sent 1,624 substantiation documents for 72 supplements; 557 (34%) were human studies. Of those: 2% studied the actual product, 85% were not randomized, double-blind, parallel-group, placebo-controlled trials, 49% used populations unlike the intended users, 189 (34%) focused on disease research, and 20 (4%) contradicted the claims.

Explanation, details and sources

The FTC guidance of December 20, 2022 says health benefits generally need “randomized, controlled human clinical testing,” that traditional-use claims face “the same requirement,” and that the guide “doesn't have the force or effect of law.” In 2012 the HHS Inspector General tested the system on 127 supplements.

Enforcement

Disease-claim warning letters follow one chain: intended use, unapproved new drug, misbranding, prohibited act

The legal chain in a joint FDA–FTC warning letterFDA record
Chain of violations in an FDA disease-claim warning letter: a claim to treat or prevent a disease, drug by intended use, unapproved new drug, misbranded drug, prohibited act; FDA asks for a reply within 48 hours, and the FTC adds that disease claims need competent and reliable scientific evidenceClaim on a website,label or social mediaproducts “intended tomitigate, prevent, treat,diagnose, or cure” adiseaseDrug by intended use§ 201(g)(1)(B) defines adrug by that intendeduseUnapproved new drugno approved application,§ 505(a)Misbranded drug§ 502Prohibited actintroduction intointerstate commerce,§ 301(a) and (d)FDA: reply within 48 hoursor face possible seizure and injunctionFTC: disease claims need competent and reliable scientificevidencejoint letter; the FTC Act also appliesChain of violations in an FDA disease-claim warning letter, with the 48-hour reply and the FTC's evidence standardClaim on a website, label or social mediaproducts “intended to mitigate, prevent, treat, diagnose,or cure” a diseaseDrug by intended use§ 201(g)(1)(B) defines a drug by that intended useUnapproved new drugno approved application, § 505(a)Misbranded drug§ 502Prohibited actintroduction into interstate commerce, § 301(a) and (d)FDA: reply within 48 hoursor face possible seizure and injunctionFTC: competent and reliable scientific evidencejoint letter; the FTC Act also applies
FDA–FTC warning letter MARCS-CMS 604813, March 6, 2020 (an herbal-products firm); 21 U.S.C. 321(g)(1)(B), 331(a), (d), 352, 355(a).
FDA's COVID-19 warning letters peaked at 70 in April to June 2020FDA data
Heat map of FDA warning letters listed on its fraudulent COVID-19 products page by calendar quarter: 2020, 13, 70, 31, 28; 2021, 26, 17, 14, 2; 2022, 15, 4, 1, 0; 221 in allJan–MarApr–JunJul–SepOct–Dec20202020 Q1: 13 letters132020 Q2: 70 letters702020 Q3: 31 letters312020 Q4: 28 letters2820212021 Q1: 26 letters262021 Q2: 17 letters172021 Q3: 14 letters142021 Q4: 2 letters220222022 Q1: 15 letters152022 Q2: 4 letters42022 Q3: 1 letters12022 Q4: 0 letters0Year total1425920Letters per quarter070221 letters, March 6, 2020 toAugust 4, 2022; all product types
FDA, Fraudulent Coronavirus Disease 2019 (COVID-19) Products, warning letter table (content current as of April 22, 2026), counted by date issued. All product types, including test kits.
Explanation, details and sources

FDA's COVID-19 letters show the pattern at scale: from March 2020 to August 2022 FDA listed 221 letters to firms selling products with claims to prevent or treat the disease, including herbal teas and tinctures.

The botanical drug pathway

A botanical can be sold to treat a disease only as an approved drug, and FDA has approved four

Six stages from pre-IND advice to approval, with the botanical-specific pointsFDA guidance
Botanical drug pathway in six stages, from pre-IND input through IND, Phase 1 to 3 studies and the NDA to approval, with the botanical-specific points of FDA's December 2016 guidancePre-INDINDPhase 1 and 2Phase 3NDAApproval•FDA encouragesinput from the reviewdivision before anIND•Optional meeting•In effect 30 daysafter FDA receives it,unless on clinicalhold (21 CFR 312.40)•A marketed botanicalsupplement with noknown safety issuesoften needs lessCMC and toxicologydetail•Preliminary CMCdata submittedbefore Phase 3 starts•Multiple-batch anddose-response data•“Substantialevidence” ofeffectiveness,§ 505(d)•Therapeuticconsistency by thetotality of theevidence•Four botanical drugs:2006, 2012, 2022,2023•Disease claims inapproved labelingCMC: chemistry, manufacturing and controls. Sources: FDA, Botanical Drug Development, Guidance for Industry, Revision 1 (December 2016); 21 CFR 312.40; FD&C Act§ 505(d).Botanical drug pathway in six stages, from pre-IND input through IND, Phase 1 to 3 studies and the NDA to approval, with the botanical-specific points of FDA's December 2016 guidance1. Pre-IND•FDA encourages input from the review divisionbefore an IND•Optional meeting2. IND•In effect 30 days after FDA receives it, unless onclinical hold (21 CFR 312.40)3. Phase 1 and 2•A marketed botanical supplement with no knownsafety issues often needs less CMC and toxicologydetail4. Phase 3•Preliminary CMC data submitted before Phase 3starts•Multiple-batch and dose-response data5. NDA•“Substantial evidence” of effectiveness, § 505(d)•Therapeutic consistency by the totality of theevidence6. Approval•Four botanical drugs: 2006, 2012, 2022, 2023•Disease claims in approved labelingCMC: chemistry, manufacturing and controls. Sources: FDA,Botanical Drug Development, Guidance for Industry,Revision 1 (December 2016); 21 CFR 312.40; FD&C Act§ 505(d).
FDA, Botanical Drug Development, Guidance for Industry, Revision 1 (December 2016); 21 CFR 312.40(b); 21 U.S.C. 355(d); Drugs@FDA.
Explanation, details and sources

FDA's December 2016 guidance adapts the IND and NDA process to plant mixtures. The four approvals are Veregen (2006), crofelemer (2012), NexoBrid (2022) and Filsuvez (2023); Course 2 shows their plants and specifications and FDA's 739 botanical INDs.

Key terms

Nine terms used in this course

Show the 9 key terms
Intended use
What a product is for, shown by labeling, advertising and websites; it sets the category.
Labeling
Labels and other written, printed or graphic matter on or accompanying a product (§ 201(m)).
Structure/function statement
A § 403(r)(6) statement about the body's structure or function, naming no disease.
Disease claim
A statement meeting a 101.93(g)(2) criterion; on a supplement it makes a drug.
Health claim
A claim linking a substance to a disease, allowed only as FDA authorizes.
Qualified health claim
A health claim below significant scientific agreement, used with FDA's qualifying words.
Substantial evidence
Adequate and well-controlled investigations of a drug's effect (§ 505(d)).
Warning letter
FDA's usual notice of what it believes are significant violations.
Botanical drug
A drug from plants, algae or macroscopic fungi, under FDA's botanical guidance.
Check your understanding

Five questions on claims

A website for a supplement says it “helps the body fight colds.” Does the disclaimer make that acceptable?

No. A disclaimer applies only to structure/function statements. A role in the body's response to disease meets criterion (viii), and a disease claim makes the product a drug whatever the disclaimer says.

Why is “maintains cholesterol levels already within the normal range” acceptable but “lowers cholesterol” not?

Lowering cholesterol is a recognized disease treatment, so FDA treats it as an implied disease claim however qualified. Maintaining normal levels describes a normal function.

Hot flashes are on FDA's list of conditions open to structure/function claims. What test put them there?

Criterion (iii): a natural-state condition is a disease only if uncommon (in fewer than half of those in the stage) or able to cause significant or permanent harm.

Who reviews the evidence behind a structure/function statement before it is used?

No one at FDA. The firm must hold substantiation and notify FDA within 30 days after first marketing; the FTC can act on advertising after the fact.

Can a botanical make a disease claim legally?

Yes, as an approved drug after an IND and an NDA showing substantial evidence, or as an authorized or qualified health claim for which the product qualifies.

Next: multi-objective ingredient design

Course 11 shows how identity, safety, evidence and regulatory status are weighed together in one ingredient decision.

Go to Course 11Discuss a claim strategy