Q.01

Which health claims does the FDA authorize on food labels?

The FDA authorizes 12 health claims on food labels. They are set out in 21 CFR 101.72 to 101.83. FDA also lets you use 6 health claims based on authoritative statements under the FDA Modernization Act (FDAMA) notification route. Qualified health claims are a third, separate group: FDA does not authorize them, but it allows them under enforcement discretion.

Approach: I searched the current eCFR text of 21 CFR Part 101 Subpart E, plus FDA's lists of claims meeting significant scientific agreement (SSA), FDAMA claims and qualified health claims. I did not look at nutrient content claims or structure/function claims.

1. Authorized health claims (NLEA, SSA standard)

To be authorized, there "must be significant scientific agreement (SSA) among qualified experts". These claims may be used on conventional foods and on dietary supplements [1].

21 CFRClaim
101.72Calcium, vitamin D, and osteoporosis [2]
101.73Dietary lipids and cancer [3]
101.74Sodium and hypertension [4]
101.75Dietary saturated fat and cholesterol and risk of coronary heart disease [5]
101.76Fiber-containing grain products, fruits, and vegetables and cancer [6]
101.77Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of CHD [7]
101.78Fruits and vegetables and cancer [8]
101.79Folate and neural tube defects [9]
101.80Dietary noncariogenic carbohydrate sweeteners and dental caries [10]
101.81Soluble fiber from certain foods and risk of CHD [11]
101.82Soy protein and risk of CHD [12]
101.83Plant sterol/stanol esters and risk of CHD [13]

Changes in progress, from FDA's SSA page (content current as of 03/28/2024) [1]:

  • Soy protein (101.82): FDA proposed revoking this claim in October 2017. The section is still in the current CFR.
  • Plant sterols/stanols (101.83):
    • In December 2010, FDA proposed a rule on "Phytosterols and Risk of Coronary Heart Disease".
    • A February 2003 FDA letter applies enforcement discretion to wider use of the interim rule [14].
  • 101.80 (dental caries): amending rules added sugar alcohols, D-tagatose and other sweeteners.
  • 101.81 (soluble fiber): amending rules added psyllium husk, oatrim, barley and barley betafiber.
  • Denied: "Alkaline and Earth Alkaline Citrates and Risk of Osteoporosis" (October 2007).

21 CFR 101.71 covers "Health claims: claims not authorized." [15]. 101.70 sets the petition procedure [16].

2. FDAMA health claims (authoritative-statement notifications)

FDA lists these 6 claims [17]:

  • Whole grain foods and the risk of heart disease and certain cancers (July 1999). A December 2003 notification covers whole grain foods with moderate fat content.
  • Potassium and the risk of high blood pressure and stroke (October 2000)
  • Fluoride (fluoridated water) and the risk of dental caries (October 2006)
  • Saturated fat, cholesterol, and trans fat, and the risk of heart disease (November 2006)
  • Substitution of saturated fat with unsaturated fatty acids and risk of heart disease (May 2007)
  • Peanut allergy: introducing allergenic foods to infants and reduced risk of developing food allergy (December 2021)

The same FDA page also lists FDAMA notifications for choline and linoleic acid. Those are nutrient content claims, not health claims.

3. Qualified health claims (enforcement discretion, not authorized)

FDA lists 40 letters under enforcement discretion. Some of them are update letters or second letters on the same claim, so there are fewer distinct claims than letters. By topic:

  • Atopic dermatitis: 100% whey-protein partially hydrolyzed infant formula [18]
  • Cancer:
    • Antioxidant vitamins C and E and site-specific cancers [19]
    • Antioxidant vitamins and certain cancers [20]
    • Calcium and colon/rectal cancer and polyps [21]
    • Green tea and breast and prostate cancer, plus an update letter [22][23]
    • Selenium and certain or site-specific cancers [24][25][26]
    • Tomatoes and prostate cancer; tomatoes and prostate, ovarian, gastric and pancreatic cancers [27][28]
  • Cardiovascular disease:
    • Cocoa flavanols [29]
    • Corn oil [30]
    • Folic acid, vitamin B6 and vitamin B12 and vascular disease, plus a settlement notice [31][32]
    • Macadamia nuts [33]
    • Monounsaturated fatty acids from olive oil [34]
    • Nuts [35]
    • Oleic acid (Corbion petition), plus a letter updating the qualifying level [36][37]
    • Omega-3 fatty acids (Martek and Wellness petitions) [38][39]
    • Soybean oil [40]
    • Canola oil [41]
    • Walnuts [42]
  • Cognitive function: Phosphatidylserine and cognitive dysfunction and dementia (two letters plus an update) [43][44][45]
  • Type 2 diabetes:
    • Chromium picolinate [46]
    • High-amylose maize starch [47]
    • Psyllium husk [48]
    • Whole grains [49]
    • Yogurt [50]
  • Hypertension:
    • Calcium and hypertension, pregnancy-induced hypertension and preeclampsia [51]
    • EPA and DHA and blood pressure [52]
    • Magnesium [53]
  • Neural tube defects: Folic acid (two letters) [54][55]
  • Peanut allergy: Ground peanuts [56]
  • Urinary tract infection: Cranberry juice beverages and dietary supplements, recurrent UTI in healthy women [57]

Each section and letter sets its own conditions, such as qualifying levels, food eligibility and required claim wording. I can pull these for any specific claim.

Q.02

What conditions must a food meet to use these claims?

Every health claim has to pass two layers of tests. First, the general eligibility rules in 21 CFR 101.14 apply to every authorized claim. Second, each claim section sets its own "nature of the food" criteria. FDAMA claims carry the conditions set in their FDA notification, and qualified claims carry the conditions in their FDA enforcement-discretion letter.

Approach: I read the current eCFR text of 21 CFR 101.14 and 101.72 to 101.83, plus FDA's FDAMA notification pages on fda.gov. For qualified claims, the records I can search hold only the letter titles, not the letter terms, so I haven't summarised them here.

1. General conditions for every authorized claim (21 CFR 101.14)

  • Disqualifying nutrient levels. For ordinary foods the limits are more than 13.0 g fat, 4.0 g saturated fat, 60 mg cholesterol or 480 mg sodium [58].
    • The limits apply per RACC (reference amount customarily consumed) and per label serving. For foods with a RACC of 30 g or less, or 2 tablespoons or less, they also apply per 50 g.
    • Going over any one of them disqualifies the food, unless the claim section in Subpart E provides an exception.
    • Meal products have higher limits: 26.0 g / 8.0 g / 120 mg / 960 mg per label serving [59].
    • Main dish products: 19.5 g / 6.0 g / 90 mg / 720 mg [60].
    • FDA can permit a claim despite a disqualifying level only through a finding in the specific Subpart E regulation. The label must then bear a 101.13(h) disclosure statement [61].
  • Minimum nutrient contribution (the 10% rule). The food must contain at least 10% of the RDI or DRV for vitamin A, vitamin C, iron, calcium, protein or fiber per RACC, counted before any nutrient is added. This does not apply to dietary supplements or where Subpart E provides otherwise [62].
  • No inappropriate level of any substance, as set by the specific claim section [63].
  • No infant or toddler foods. The label may not represent the food as being for children under 2, unless Subpart E specifically provides for the claim [64].
  • Level of the substance.
    • For a claim about eating less of a substance, the food must meet the "low" definition where one exists [65].
    • Otherwise the food must meet the "high" definition, or the claim must state the daily intake needed [66].
    • If the food qualifies on its RACC but the labeled serving is different, a statement explaining this "shall" follow the claim [67].
  • Claim content. The claim must:
    • be consistent with the Subpart E conclusions and framed "as part of a total dietary pattern" [68][69];
    • be complete, truthful and not misleading [70];
    • appear in one place. A "See ___ for information about…" referral on the principal display panel is allowed, and graphics such as a heart symbol must sit next to the claim or the referral [71].
  • Nutrition labeling "shall" be provided under 101.9, 101.10 for restaurant foods, or 101.36 for supplements [72].
  • Restaurants and ready-to-eat establishments can qualify if the seller has a reasonable basis for believing the food meets the level requirements and provides that basis on request [73].

2. Claim-specific "nature of the food" criteria

SectionWhat the food must meet
101.72 Calcium, vitamin D and osteoporosis"High" in calcium [74]. Calcium must be assimilable [75]. Supplements must meet USP disintegration and dissolution standards [76]. No more phosphorus than calcium, by weight [77]
101.73 Dietary lipids and cancer"Low fat". Fish and game meats may meet "extra lean" instead [78]
101.74 Sodium and hypertension"Low sodium" [79]
101.75 Saturated fat, cholesterol and CHD"Low saturated fat" and "low cholesterol" [80]. "Low fat", unless a raw fruit or vegetable; fish and game meats may meet "extra lean" [81]. Raw fruits and vegetables are exempt from the 10% rule [82]
101.76 Fiber-containing grain products, fruits, vegetables and cancerIs or contains a grain product, fruit or vegetable [83]. "Low fat" [84]. "Good source" of dietary fiber without fortification [85]
101.77 Fruits, vegetables and grain products with soluble fiber, and CHDIs or contains a fruit, vegetable or grain product [86]. Low saturated fat, low cholesterol and low fat [87]. At least 0.6 g soluble fiber per RACC without fortification [88]. Soluble fiber declared on the label [89]
101.78 Fruits, vegetables and cancerIs or contains a fruit or vegetable [90]. "Low fat" [91]. "Good source" of vitamin A, vitamin C or fiber without fortification [92]
101.79 Folate and neural tube defects"Good source" of folate [93]. Supplements must meet USP standards or show bioavailability [94]. Not allowed on foods with more than 100% of the RDI for vitamin A (as retinol or preformed vitamin A) or vitamin D [95]. Folate declared on the label [96]. Above 100% DV, the claim must state the safe upper limit [97]
101.80 Noncariogenic sweeteners and dental cariesContains a listed sweetener [98]: listed sugar alcohols [99], D-tagatose, isomaltulose [100] or sucralose [101]. Meets the "sugar free" sugars criterion of 101.60(c)(1)(i), except that D-tagatose or isomaltulose may be present [102]. If other carbohydrates are present, the food must not lower plaque pH below 5.7 [103]. Exempt from the 10% rule [104]
101.81 Soluble fiber and CHDAt least 0.75 g soluble fiber per RACC from whole oat or barley sources [105]. Or at least 0.75 g beta-glucan from oatrim or barley betafiber [106]. Or at least 1.7 g soluble fiber from psyllium husk of at least 95% purity [107][108]. Soluble fiber declared [109]. Low saturated fat and low cholesterol [110]. Low fat, unless the excess fat comes from whole oat sources [111]
101.82 Soy protein and CHDAt least 6.25 g soy protein per RACC [112]. Low saturated fat and low cholesterol [113]. Low fat, unless the food is from whole soybeans with no added fat [114]. Manufacturers must keep records that support the soy protein ratio [115]
101.83 Plant sterol/stanol esters and CHDAt least 0.65 g sterol esters per RACC in spreads and salad dressings [116]. Or at least 1.7 g stanol esters in spreads, salad dressings, snack bars and softgel supplements [117]. Low saturated fat and low cholesterol [118]. Spreads and dressings are exempt from the per-50 g fat limit if they carry a 101.13(h) disclosure [119]. Salad dressings are exempt from the 10% rule [120]

Only three sections exempt foods from the general rules: 101.75, 101.80 and 101.83. For every other section, all of 101.14 applies in full.

3. FDAMA claims (from FDA's notification pages)

  • Whole grain foods (1999): at least 51% whole grain ingredients by weight per RACC. Dietary fiber is the marker: 11 g × 51% × RACC/100.
  • Whole grain foods with moderate fat (2003):
    • at least 51% whole grain;
    • low saturated fat and low cholesterol (1 g or less and 20 mg or less per RACC);
    • less than 6.5 g total fat and 0.5 g or less trans fat per RACC;
    • quantitative trans fat labeling.
  • Potassium:
    • good source of potassium (at least 350 mg per RACC);
    • low sodium (140 mg or less);
    • low fat (3 g or less), low saturated fat (1 g or less, and no more than 15% of calories) and low cholesterol (20 mg or less).
  • Fluoridated water:
    • bottled water meeting 21 CFR 165.110, with total fluoride above 0.6 and up to 1.0 mg/L;
    • the 10% rule is waived;
    • not for bottled water marketed for infants.
  • Saturated fat, cholesterol and trans fat:
    • 1 g or less saturated fat and 20 mg or less cholesterol per RACC;
    • less than 0.5 g trans fat and less than 6.5 g total fat;
    • sodium no more than 480 mg;
    • the 10% rule applies.
  • Substituting unsaturated for saturated fat: unsaturated fat must make up 80% or more of total fat. FDA lists vegetable oils, spreads, shortenings and oil-containing foods as examples.
  • Peanut allergy: conventional foods or dietary supplements containing peanut in an age-appropriate form. The claim uses FDA's exact wording, including the statement that caregivers should check with the baby's healthcare provider.

4. Qualified health claims

The conditions for qualified claims (qualifying levels, eligible foods, mandatory wording) are set out in each FDA enforcement-discretion letter. The records I can search hold only the letter titles, for example "Walnuts and Coronary Heart Disease" [42]. I can open the letter for any specific qualified claim and pull its conditions.

Q.03