Claims That CAN Be Made For Dietary Supplements

HOW NOT TO GET TARGETED
BY THE FDA AND FTC
The Secret of Making Proper

Structure/Function Claims
Claims That CAN Be Made

For Dietary Supplements
OK, now were getting to some of the really big, sexy (and mission-critical) stuff.
Claims that can be made for dietary supplements fall into three categories: (1)
health claims (moderately sexy); (2) nutrient content claims (not sexy at all); and (3)
structure/function claims (ultra-dead sexy).
1. Health Claims (These are Moderately Sexy)

Health claims describe a relationship between a dietary supplement or dietary
ingredient, and reducing risk of a disease or health-related condition.
Youre probably thinking, Hmmm . . . reducing the risk of a disease sure sounds like
a disease prevention claim. Youre right! It really is, which would normally make such
a claim a drug claim . . . except when the FDA has approved a disease reduction
(prevention) claim as a health claim.
A "health claim" by definition has two essential components: (1) a substance (a
food, food component, or dietary ingredient) and (2) a disease or health-related condition.
A statement lacking either one of these components does not meet the regulatory definition
of a health claim. Statements that address a role of a specific substance in maintaining
normal healthy structures or functions of the body are considered to be structure/function
claims.
There are three different types of health claims that may be used on a label or in
labeling of a dietary supplement: (1) the 1990 Nutrition Labeling and Education Act (NLEA)
provides for FDA to issue regulations authorizing health claims for foods and dietary
supplements after FDA's review of the scientific evidence submitted in health claim
petitions [I will call this category of health claim a regular health claim ]; (2) the 1997 Food
and Drug Administration Modernization Act (FDAMA) provides for health claims for
conventional foods based on an authoritative statement of a scientific body of the U.S.
government or the National Academy of Sciences; and (3) the 2003 FDA Customer Health
Information for Better Nutrition Initiative provides for qualified health claims where the
quality and strength of the scientific evidence falls below that required for FDA to issue a
regulation to authorize a regular health claim. Qualified health claims must be qualified
to assure accuracy and non-misleading presentation to customers.
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KGRIMES@THOMPSONBURTON.COM
2014 KEVIN D. GRIMES

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a. Currently Approved Health Claims1

You will find below all of the health claims that the FDA has authorized by
regulation. Some of them are not relevant to dietary supplements, and thus, I will not
discuss them below.
101.72 Health claims: calcium, vitamin D, and osteoporosis
101.73 Health claims: dietary lipids and cancer
101.74 Health claims: sodium and hypertension
101.75 Health claims: dietary saturated fat and cholesterol and risk of coronary
heart disease
101.76 Health claims: fiber-containing grain products, fruits, and vegetables and
cancer
101.77 Health claims: fruits, vegetables, and grain products that contain fiber,
particularly soluble fiber, and risk of coronary heart disease
101.78 Health claims: fruits and vegetables and cancer
101.79 Health claims: Folate and neural tube defects
101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental
caries
101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart
disease (CHD)
101.82 Health claims: Soy protein and risk of coronary heart disease (CHD)
101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease
(CHD)
As I mentioned above, I appreciate that you not be interested in making any of these
claims for your product . . . but then again, you might be. Thus, in the interest of providing
you with a scorched-earth, thermonuclear, mother-of-all-references . . . here they are.
i. Calcium, Vitamin D, and Osteoporosis (21 CFR 101.72)
(1) Model Health Claims for Calcium and Osteoporosis
There are other health claims authorized by regulation, however, they are applicable only to
conventional foods not dietary supplements. These include: Sodium and Hypertension (21 CFR 101.74),
Dietary Fat and Cancer (21 CFR 101.73), Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart
Disease (21 CFR 101.75), Fruits, Vegetables and Grain Products that contain Fiber, particularly Soluble Fiber,
and Risk of Coronary Heart Disease (21 CFR 101.77), Fruits and Vegetables and Cancer (21 CFR 101.78),
Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries (21 CFR 101.80), Soluble Fiber from
Certain Foods and Risk of Coronary Heart Disease (21 CFR 101.81), Soy Protein and Risk of Coronary Heart
Disease (21 CFR 101.82).
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(a) Model Health Claim 1 Adequate calcium throughout life, as part of a

well-balanced diet, may reduce the risk of osteoporosis.
(b) Model Health Claim 2 Adequate calcium as part of a healthful diet,
along with physical activity, may reduce the risk of osteoporosis in later life.
(2) Model health claims for Calcium, Vitamin D and Osteoporosis
(a) Model Health Claim 1 Adequate calcium and vitamin D throughout life,
as part of a well-balanced diet, may reduce the risk of osteoporosis.
(b) Model Health Claim 2 Adequate calcium and vitamin D as part of a
healthful diet, along with physical activity, may reduce the risk of
osteoporosis in later life.
(3) Requirements (there are a bunch!) are all set forth in 21 CFR 101.72(c).
I wont list them here, because you will find them in Appendix 17.
(4) Optional Information You may include the optional information articulated
in 21 CFR 101.72(d).
ii. Fiber-containing Grain Products, Fruits, Vegetables, and Cancer (21 CFR
101.76)
(1) Model Health Claims for Grain Products, Fruits, Vegetables, and Cancer
(a) Model Health Claim 1 Low fat diets rich in fiber-containing grain
products, fruits, and vegetables may reduce the risk of some types of cancer,
a disease associated with many factors.
(b) Model Health Claim 2 Development of cancer depends on many
factors. Eating a diet low in fat and high in grain products, fruits, and
vegetables that contain dietary fiber may reduce your risk of some cancers.
(2) Requirements (there arent very many) are all set forth in 21 CFR
101.76(c).
in 21 CFR 101.76(d).
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iii. Fruits, Vegetables, and Grain Products That Contain Fiber, Particularly
Soluble Fiber, and Risk of Coronary Heart Disease (21 CFR 101.77)
(1) Model Health Claims for Fruits, Vegetables, and Grain Products That
Contain Fiber, Particularly Soluble Fiber, and Risk of Coronary Heart
Disease
(a) Model Health Claim 1 Diets low in saturated fat and cholesterol and
rich in fruits, vegetables, and grain products that contain some types of
dietary fiber, particularly soluble fiber, may reduce the risk of heart disease,
a disease associated with many factors.
(b) Model Health Claim 2 Development of heart disease depends on many
factors. Eating a diet low in saturated fat and cholesterol and high in fruits,
vegetables, and grain products that contain fiber may lower blood cholesterol
levels and reduce your risk of heart disease.
(2) Requirements are all set forth in 21 CFR 101.77(c).
in 21 CFR 101.77(d).
iv. Fruits, Vegetables, and Cancer (21 CFR 101.78)
(1) Model Health Claims for Fruits, Vegetables, and Cancer
(a) Model Health Claim 1 Low fat diets rich in fruits and vegetables (foods
that are low in fat and may contain dietary fiber, vitamin A, and vitamin C)
may reduce the risk of some types of cancer, a disease associated with
many factors. Broccoli is high in vitamins A and C, and it is a good source of
dietary fiber.
(b) Model Health Claim 2 Development of cancer depends on many
factors. Eating a diet low in fat and high in fruits and vegetables, foods that
are low in fat and may contain vitamin A, vitamin C, and dietary fiber, may
reduce your risk of some cancers. Oranges, a food low in fat, are a good
source of fiber and vitamin C.
(2) Requirements are all set forth in 21 CFR 101.78(c).
in 21 CFR 101.78(d).
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v. Folate and Neural Tube Defects (21 CFR 101.79)

(1) Model Health Claims
(a) Model Health Claim 1 (a model health claim for products containing
100 percent or less of the DV for folate per serving or per unit; this example
contains only the required elements) Healthful diets with adequate folate
may reduce a woman's risk of having a child with a brain or spinal cord birth
defect.
(b) Model Health Claim 2 (a model health claim for products containing
contains only the required elements) Adequate folate in healthful diets may
reduce a woman's risk of having a child with a brain or spinal cord birth
defect.
(c) Model Health Claim 3 (a model health claim for products containing
contains all required elements plus optional information) -- Women who
consume healthful diets with adequate folate throughout their childbearing
years may reduce their risk of having a child with a birth defect of the brain
or spinal cord. Sources of folate include fruits, vegetables, whole grain
products, fortified cereals, and dietary supplements.
(d) Model Health Claim 4 (a model health claim for products containing
more than 100 percent of the DV of folate per serving or per unit) Women
who consume healthful diets with adequate folate may reduce their risk of
having a child with birth defects of the brain or spinal cord. Folate intake
should not exceed 250% of the DV (1,000 mcg).
(2) Requirements There are a bunch, and they are set forth in 21 CFR
101.79(c)(1) - (2), which you will find in Appendix 17.
(3) Optional Information The optional information you may include in a
folate/neural tube defect claim is set forth in 21 CFR 101.79(c)(3).
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vi. Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease (21
CFR 101.81)
(a) Model Health Claim 1 Soluble fiber from foods such as [name of
soluble fiber source and, if desired, the name of food product], as part of a
diet low in saturated fat and cholesterol, may reduce the risk of heart
disease. A serving of [name of product] supplies ____ grams of the [grams
of soluble fiber] soluble fiber from [name of the soluble fiber source]
necessary per day to have this effect.
(b) Model Health Claim 2 Diets low in saturated fat and cholesterol that
include [____ grams of soluble fiber] of soluble fiber per day from [name of
soluble fiber source and, if desired, the name of the product] may reduce the
risk of heart disease. One serving of [name of the product] provides ____
grams of this soluble fiber.
101.81(c).
(3) Optional Information The optional information you may include in a soluble
fiber/coronary heart disease claim is set forth in 21 CFR 101.81(d)
vii.
Soy Protein and Risk of Coronary Heart Disease (21 CFR 101.82)
(a) Model Health Claim 1 25 grams of soy protein a day, as part of a diet
low in saturated fat and cholesterol, may reduce the risk of heart disease. A
serving of [name of food] supplies __ grams of soy protein.
(b) Model Health Claim 2 Diets low in saturated fat and cholesterol that
include 25 grams of soy protein a day may reduce the risk of heart disease.
One serving of [name of food] provides __ grams of soy protein.
(2) Requirements are set forth in 21 CFR 101.82(c).
(3) Optional Information The optional information you may include in a soy
protein/coronary heart disease claim is set forth in 21 CFR 101.82(d)
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viii.

Plant Sterol/stanol esters and Risk of Coronary Heart Disease (21 CFR
101.83)

(a) Model Health Claim 1 (For plant sterol esters) Foods containing at
least 0.65 g per serving of plant sterol esters, eaten twice a day with meals
for a daily total intake of at least 1.3 g, as part of a diet low in saturated fat
and cholesterol, may reduce the risk of heart disease. A serving of [name of
the product] supplies ___grams of vegetable oil sterol esters.
(b) Model Health Claim 2 (For plant sterol esters) Diets low in saturated
fat and cholesterol that include two servings of foods that provide a daily total
of at least 1.3 g of vegetable oil sterol esters in two meals may reduce the
risk of heart disease. A serving of [name of the product] supplies ___grams
of vegetable oil sterol esters.
(c) Model Health Claim 3 (For plant stanol esters) Foods containing at
least 1.7 g per serving of plant stanol esters, eaten twice a day with meals
for a total daily intake of at least 3.4 g, as part of a diet low in saturated fat
and cholesterol, may reduce the risk of heart disease. A serving of [name of
the product] supplies ___grams of plant stanol esters.
(d) Model Health Claim 4 (For plant stanol esters) Diets low in saturated
fat and cholesterol that include two servings of foods that provide a daily total
of at least 3.4 g of vegetable oil stanol esters in two meals may reduce the
risk of heart disease. A serving of [name of the product] supplies ___grams
of vegetable oil stanol esters.
101.83(c) (Appendix 17).
(3) Optional Information The optional information you may include in a soluble
fiber/coronary heart disease claim is set forth in 21 CFR 101.83(d)
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b. Health Claims Authorized Based on an Authoritative Statement by a Scientific

Body2
The Food and Drug Administration Modernization Act of 1997 (FDAMA) provides
a second way for the use of a health claim on conventional foods to be authorized.
FDAMA allows certain health claims to be made as a result of a successful notification to
FDA of a health claim based on an "authoritative statement" from a scientific body of the
U.S. Government or the National Academy of Sciences.
The FDAMA does not include dietary supplements in the provisions for health claims
based on authoritative statements. Consequently, health claims based on authoritative
statements cannot be used for dietary supplements at this time. The FDA has said that
someday it intends to propose that health claims based on authoritative statements be
permitted for dietary supplements. Heaven only knows when that will be.
c. Qualified Health Claims3
The FDA's 2003 Customer Health Information for Better Nutrition Initiative allows
the use of qualified health claims when there is emerging evidence for a relationship
between a food, food component, or dietary supplement and reduced risk of a disease or
health-related condition. In this case, the evidence is not strong enough to meet the
significant scientific agreement standard required for the FDA to issue a regulation that
authorizes a (full blown regular) health claim. Qualifying language is included as part of
the claim to indicate that the evidence supporting the claim is limited. Both conventional
foods and dietary supplements may use qualified health claims.
The FDA uses its enforcement discretion for qualified health claims after
evaluating and ranking the quality and strength of the totality of the scientific evidence.
Although FDA's "enforcement discretion" letters are issued to a specific petitioner who
requests the qualified health claim, the qualified claims are available for use on any food
There are other health claims authorized based on an authoritative statement by a federal scientific
body, including: (1) Saturated Fat, Cholesterol, and Trans Fat, and Reduced Risk of Heart Disease; (2)
Fluoridated Water and Reduced Risk of Dental Carries;(3) Whole Grain Foods and Risk of Heart Disease and
Certain Cancers; and (4) Potassium and the Risk of High Blood Pressure and Stroke. These claims are,
however, applicable only to conventional foods.
3
As is true for all types of health claims, there are certain qualified health claims that can only be
made for conventional foods. These include the cancer risk claims for tomatoes and/or tomato sauce for
prostate, ovarian, gastric, and pancreatic cancers. Unfortunately, these claims can only be made for products
that contain cooked, raw, dried, or canned tomatoes, and tomato sauces that contain at least 8.37 percent
salt-free tomato solids . . . which probably will not be a dietary supplement.
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or dietary supplement product meeting the enforcement discretion conditions specified in

the letter.
The claims set forth below are the actual claims that you can (and must, if you
choose to do so) use. You may not change the wording at all.
i. 0.8 mg Folic Acid & Neural Tube Birth Defects
This claim can be made for dietary supplements containing folic acid.
0.8 mg folic acid in a dietary supplement is more effective in reducing the risk
of neural tube defects than a lower amount in foods in common form. FDA
does not endorse this claim. Public health authorities recommend that
women consume 0.4 mg folic acid daily from fortified foods or dietary
supplements or both to reduce the risk of neural tube defects.
The disclaimer (i.e., FDA does not endorse this claim...) must be placed immediately
adjacent to and directly beneath the claim (i.e., 0.8 mg folic acid ...), with no intervening
material, in the same size, typeface, and contrast as the claim.
Remember there also is a folic acid/neural tube defect health claim authorized by
regulation (see 21 CFR 101.79).
ii. B Vitamins and Vascular Disease
This claim can be made for dietary supplements containing vitamin B6, B12, and/or
folic acid.
As part of a well-balanced diet that is low in saturated fat and cholesterol,
Folic Acid, Vitamin B6 and Vitamin B12 may reduce the risk of vascular
disease. FDA evaluated the above claim and found that, while it is known
that diets low in saturated fat and cholesterol reduce the risk of heart disease
and other vascular diseases, the evidence in support of the above claim is
inconclusive.
The disclaimer (i.e., FDA evaluated the above claim...) must be immediately
adjacent to and directly beneath the first claim (i.e., As part of a well-balanced diet... ) with
no intervening material that separates the claim from the disclaimer, and the second
sentence must be in the same size, type face and contrast as the first sentence.
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Products that contain more than 100 percent of the Daily Value (DV) of folic acid
(400 micrograms), when labeled for use by adults and children 4 or more years of age,
must identify the safe upper limit of daily intake with respect to the DV. The folic acid safe
upper limit of daily intake value of 1,000 micrograms (1 mg) may be included in
parentheses.
Dietary supplements containing folic acid must meet the United States
Pharmacopeia (USP) standards for disintegration and dissolution, except that if there are
no applicable USP standards, the folate in the dietary supplement shall be shown to be
bioavailable under the conditions of use stated on the product label.
iii. Cancer Risks Selenium and Cancer
The following two qualified health claims may be made for dietary supplements
containing selenium.
Selenium may reduce the risk of certain cancers. Some scientific evidence
suggests that consumption of selenium may reduce the risk of certain forms
of cancer. However, FDA has determined that this evidence is limited and
not conclusive.
Selenium may produce anticarcinogenic effects in the body. Some scientific
evidence suggests that consumption of selenium may produce
anticarcinogenic effects in the body. However, FDA has determined that this
evidence is limited and not conclusive.
The disclaimer (i.e., Some scientific evidence suggests...) must be placed
immediately adjacent to and directly beneath the claim (i.e., Selenium may reduce the risk),
with no intervening material, in the same size, typeface, and contrast as the claim itself.
The supplement cannot recommend or suggest in its labeling, or under ordinary
conditions of use, a daily intake exceeding the Tolerable Upper Intake Level established
by the National Academy of Sciences/Institute of Medicine for selenium (400 micrograms
per day). Dietary supplements bearing the claim(s) must meet the nutrient content claim
definition for high (i.e., 20% or more of the daily value (DV) per RACC [Reference Amounts
Customarily Consumed]); 20% DV for selenium is 14 micrograms.
iv. Antioxidant Vitamins and Cancer
These claims may be made for dietary supplements containing vitamin E and/or
vitamin C.
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Some scientific evidence suggests that consumption of antioxidant vitamins

may reduce the risk of certain forms of cancer. However, FDA has
determined that this evidence is limited and not conclusive.
Some scientific evidence suggests that consumption of antioxidant vitamins
may reduce the risk of certain forms of cancer. However, FDA does not
endorse this claim because this evidence is limited and not conclusive.
FDA has determined that although some scientific evidence suggests that
consumption of antioxidant vitamins may reduce the risk of certain forms of
cancer, this evidence is limited and not conclusive.
The disclaimer (i.e., ...evidence is limited and not conclusive) must be placed
immediately adjacent to and below the claim, with no intervening material, in the same
size, typeface, and contrast as the claim itself. (Im guessing that you are seeing a pattern
. . .)
The supplement cannot recommend or suggest in its labeling, or under ordinary
conditions of use, a daily intake exceeding the Tolerable Upper Intake Levels established
by the Institute of Medicine for vitamin C (2000 mg per day) or for vitamin E (1000 mg per
day). Paragraph 101.14(d)(2)(vii) requires that the food bearing the claim meet the nutrient
content claim definition for high (i.e., 20% or more of the daily value (DV) per RACC). 20%
DV for vitamin C is 12 mg; 20% DV for vitamin E is 6 IU.
v. Phosphatidylserine and Cognitive Dysfunction and Dementia
These claims may be made for dietary supplements containing soy-derived
phosphatidylserine.
Consumption of phosphatidylserine may reduce the risk of dementia in the
elderly. Very limited and preliminary scientific research suggests that
phosphatidylserine may reduce the risk of dementia in the elderly. FDA
concludes that there is little scientific evidence supporting this claim.
Consumption of phosphatidylserine may reduce the risk of
dysfunction in the elderly. Very limited and preliminary scientific
suggests that phosphatidylserine may reduce the risk of
dysfunction in the elderly. FDA concludes that there is little
evidence supporting this claim.
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The disclaimer (i.e., Very limited and preliminary scientific research...) must be
placed immediately adjacent to and directly beneath the claim (i.e., Phosphatidylserine
may reduce...), with no intervening material, in the same size, typeface, and contrast as
the claim itself.
The FDAs letter says, [t]he soy-derived phosphatidylserine used must be of very
high purity. What does that mean? I have no idea neither does the FDA.
vi. Omega-3 Fatty Acids and Coronary Heart Disease
This claim may be made for conventional foods and dietary supplements that
contain EPA and DHA omega-3 fatty acids.
Supportive but not conclusive research shows that consumption of EPA and
DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One
serving of [name of the product] provides [__] gram of EPA and DHA
omega-3 fatty acids. [See nutrition information for total fat, saturated fat, and
cholesterol content.] 4
Dietary supplements should not recommend or suggest in their labeling a daily
intake exceeding 2 grams of EPA and DHA.
Dietary supplements that weigh 5 g or less per RACC (which is an FDA abbreviation
for Reference Amounts Customarily Consumed) (RACC for dietary supplement is labeled
serving size) are exempted from the total fat disqualifying level, but if dietary supplements
that weigh 5 g or less per RACC exceed the total fat disqualifying level (13.0 g per 50 g)
the disclosure statement (i.e., "See nutrition information for total fat content") must be
placed immediately adjacent to the health claim. Dietary supplements that weigh more
than 5 g per RACC must not exceed the total fat disqualifying level (13.0 g per RACC and
per 50 g if RACC is 30 g or less, or 2 tbsp or less).
Dietary supplements must meet the criterion for low saturated fat with regard to the
saturated fat content (1 g or less per RACC) but not with regard to the no more than 15
percent calories from saturated fat criterion.
Dietary supplements that weigh 5 g or less per RACC are exempt from the
cholesterol disqualifying level (60 mg per 50 g), but those that exceed the cholesterol
disqualifying level must include "See nutrition information for cholesterol content" with the
Dietary supplements may declare the amount of EPA and DHA per serving in "Supplement Facts,"
instead of making the declaration in the claim.
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health claim. Dietary supplements that weigh more than 5 g per RACC must meet the
criterion for low cholesterol (20 mg or less per 50g).
Dietary supplements must meet the sodium disqualifying level (480 mg or less per
RACC and per 50 g if RACC is 30 g or less, or 2 tbsp or less for individual foods).
vii.
Cancer Risks Green Tea and Cancer
These claims can be made for green tea in conventional foods and dietary
supplements that contain green tea.
Two studies do not show that drinking green tea reduces the risk of breast
cancer in women, but one weaker, more limited study suggests that drinking
green tea may reduce this risk. Based on these studies, FDA concludes that
it is highly unlikely that green tea reduces the risk of breast cancer.
One weak and limited study does not show that drinking green tea reduces
the risk of prostate cancer, but another weak and limited study suggests that
drinking green tea may reduce this risk. Based on these studies, FDA
concludes that it is highly unlikely that green tea reduces the risk of prostate
cancer.
The product must not exceed the disqualifying nutrient levels for total fat, saturated
fat, cholesterol, and sodium specified in 21 CFR 101.14(a)(4). These levels are 13.0
grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, or 480 mg of
sodium, per reference amount customarily consumed, per label serving size, and, only for
foods with reference amounts customarily consumed of 30 g or less or 2 tablespoons or
less.
The product must also not exceed the 10% minimum nutrient content requirement
in 21 CFR 101.14(e)(6). This means that a green tea product may not contain 10% or
more of the Reference Daily Intake or the Daily Reference Value for vitamin A, vitamin C,
iron, calcium, protein, or fiber per reference amount customarily consumed.
viii.
Chromium Picolinate and Diabetes
This claim can be made for dietary supplements that contain chromium picolinate.
One small study suggests that chromium picolinate may reduce the risk of
insulin resistance, and therefore possibly may reduce the risk of type 2
diabetes. FDA concludes, however, that the existence of such a relationship
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between chromium picolinate and either insulin resistance or type 2 diabetes

is highly uncertain.
Dietary supplement containing chromium must meet or exceed the requirement for
a "high" level of chromium as defined in 21 CFR 101.54(b) (i.e., 24 mg or more per
reference amount customarily consumed under the current regulation).
ix. Cancer Risks Calcium and Colon/Rectal Cancer and Calcium and
Recurrent Colon/Rectal Polyps
These claims can be made for dietary supplements containing more than 200 mg
of calcium per reference amount customarily consumed.
(a) Claim Statement for Colon/Rectal Cancer
Some evidence suggests that calcium supplements may reduce the risk of
colon/rectal cancer, however, FDA has determined that this evidence is
limited and not conclusive.
(b) Claim Statement for Recurrent Colon Polyps
Very limited and preliminary evidence suggests that calcium supplements
may reduce the risk of colon/rectal polyps. FDA concludes that there is little
scientific evidence to support this claim.
The calcium content of the dietary supplement must be assimilable (i.e.,
bioavailable), and meet the United States Pharmacopeia (U.S.P.) standards for
disintegration and dissolution applicable to their component calcium salts.5 For dietary
supplements for which no U.S.P. standards exist, the dietary supplement must exhibit
appropriate assimilability under the conditions of use stated on the product label. 6
x. Calcium and Hypertension, Pregnancy-Induced Hypertension, and
Preeclampsia
These claims can be made for dietary supplements containing calcium.
21 CFR 101.72(c)(ii)(B)
21 CFR 101.72(c)(ii)(C)
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Some scientific evidence suggests that calcium supplements may reduce the
risk of hypertension. However, FDA has determined that the evidence is
inconsistent and not conclusive.
Four studies, including a large clinical trial, do not show that calcium
supplements reduce the risk of pregnancy-induced hypertension during
pregnancy. However, three other studies suggest that calcium supplements
may reduce the risk. Based on these studies, FDA concludes that it is highly
unlikely that calcium supplements reduce the risk of pregnancy-induced
hypertension.
Three studies, including a large clinical trial, do not show that calcium
supplements reduce the risk of preeclampsia during pregnancy. However,
two other studies suggest that calcium supplements may reduce the risk.
Based on these studies, FDA concludes that it is highly unlikely that calcium
supplements reduce the risk of preeclampsia.
The dietary supplement must meet or exceed the requirement for a "high" level of
calcium as defined in 21 CFR 101.54(b) (i.e., 200 mg or more calcium per reference
amount customarily consumed). The calcium content of the dietary supplement must be
assimilable (i.e., bioavailable),7 and meet the United States Pharmacopeia (U.S.P.)
standards for disintegration and dissolution applicable to their component calcium salts.
For dietary supplements for which no U.S.P. standards exist, the dietary supplement must
exhibit appropriate assimilability under the conditions of use stated on the product label.8
2. Nutrient Content Claims (These Are Not Sexy At All)

The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label
claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) made
in accordance with FDA's authorizing regulations. Nutrient content claims describe the
level of a nutrient or dietary substance in the product, using terms such as free, high,
and low, or they compare the level of a nutrient in a food to that of another food, using
terms such as more, reduced, and lite. An accurate quantitative statement (e.g., 200
mg of sodium) that does not "characterize" the nutrient level may be used to describe any
amount of a nutrient present. However, a statement such as "only 200 mg of sodium"
characterizes the level of sodium as being low and would therefore need to conform to the
criteria of an appropriate nutrient content claim or carry a disclosure statement that it does
7
21 CFR 101.72(c)(ii)(B).
21 CFR 101.72(c)(ii)(C).
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not comply with the claim. Most nutrient content claim regulations apply only to those
nutrients or dietary substances that have an established daily value.
The requirements that govern the use of nutrient content claims help ensure that
descriptive terms, such as high or low, are used consistently for all types of food
products. Healthy has been defined by a regulation as an implied nutrient content claim
that characterizes a food that has "healthy" levels of total fat, saturated fat, cholesterol and
sodium.
Percentage claims for dietary supplements are another category of nutrient content
claims. These claims are used to describe a percentage level of a dietary ingredient for
which there is no established Daily Value. Examples include simple percentage
statements such as "40% omega-3 fatty acids, 10 mg per capsule," and comparative
percentage claims, e.g., "twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg
of menhaden oil (40 mg)." (See 21 CFR 101.13(q)(3)(ii)).
The requirements regarding certain nutrient content claims are:
i.
"High," "Rich In," or "Excellent Source Of"

The product must contain 20% or
more of the DV per RACC (Reference Amounts Customarily Consumed).
ii. "Good Source," "Contains," or "Provides" The product must contain 10%-19%
of the DV per RACC.
iii. "More," "Fortified," "Enriched," "Added," "Extra," or "Plus" The product must
contain 10% or more of the DV per RACC. These terms may only be used for
vitamins, minerals, protein, dietary fiber, and potassium.
iv. "High Potency" May be used on foods to describe individual vitamins or
minerals that are present at 100% or more of the RDI per RACC or on a
multi-ingredient food product that contains 100% or more of the RDI for at least
2/3 of the vitamins and minerals with RDIs and that are present in the product
at 2% or more of the RDI (e.g., "High potency multivitamin, multi-mineral dietary
supplement tablets").
v. Claims using the term "antioxidant" For claims characterizing the level of
antioxidant nutrients in a food:
(1) an RDI must be established for each of the nutrients that are the subject of
the claim;
(2) each nutrient must have existing scientific evidence of antioxidant activity;
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(3) the level of each nutrient must be sufficient to meet the definition for "high,"
"good source," or "more";
(4) beta-carotene may be the subject of an antioxidant claim when the level of
vitamin A present as beta-carotene in the food is sufficient to qualify for the
claim.
3. Structure/Function Claims (These are Ultra Dead Sexy!)

Structure/function claims have historically appeared on the labels of conventional
foods and dietary supplements as well as drugs. However, the Dietary Supplement Health
and Education Act of 1994 (DSHEA) established some special regulatory procedures for
such claims for dietary supplements. Structure/function claims describe the role of a
nutrient or dietary ingredient intended to affect normal structure or function in humans,
for example, "calcium builds strong bones." In addition, they may characterize the means
by which a nutrient or dietary ingredient acts to maintain such normal structure or
function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell
integrity," or they may describe general well-being from consumption of a nutrient or dietary
ingredient.9
On January 6, 2000, the FDA published a final rule (regulation), 21 CFR 101.93(f)
defining the types of statements that may be used on the label and in the labeling of dietary
supplements without prior review by the FDA.10 Called structure/function claims, these
claims are statements that describe the effect a dietary supplement may have on the
structure or function of the body. More precisely, the Dietary Supplement Health and
Education Act defines a structure/function claim as one that:
(1) describes the role of a nutrient or dietary ingredient intended to affect the
structure or function in humans, or
(2) characterizes the documented mechanism by which a nutrient or dietary
ingredient acts to maintain such structure or function.
The regulation also articulates when a statement about a dietary supplement is a disease
claim (that is, a claim to diagnose, cure, mitigate, treat, or prevent disease), which has
already been addressed in Chapter 8. As we have already discussed, disease claims
Structure/function claims may also describe a benefit related to a nutrient deficiency disease (like
vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United
States.
10
65 Federal Register 1000.
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require prior approval by the FDA and may be made only for products that are either: (1)
approved drug products (see the definition of a drug); or (2) dietary supplements or foods
that are "health claims" (see above). Unlike health claims, structure/function claims are not
subject to FDA review and authorization.
Section 101.93(f) provides:
(f) Permitted structure/function statements. Dietary supplement labels or
labeling may, subject to the requirements in paragraphs (a) through (e) of
this section, bear statements that describe the role of a nutrient or dietary
ingredient intended to affect the structure or function in humans or that
characterize the documented mechanism by which a nutrient or dietary
ingredient acts to maintain such structure or function, provided that such
statements are not disease claims under paragraph (g) of this section. If the
label or labeling of a product marketed as a dietary supplement bears a
disease claim as defined in paragraph (g) of this section, the product will be
subject to regulation as a drug unless the claim is an authorized health claim
for which the product qualifies.
According to the FDA, structure/function claims may not explicitly or implicitly link
the relationship to a disease or health related condition.
However . . .
You can make a lot of structure/function claims that pretty much get you to the same
place!
a. Requirements
There are four requirements you must meet to make structure/function claims. You
must:
(a) have substantiation for your claims;
(b) the claims must be truthful and not misleading;
(c) you must notify the FDA that you are using the claim within 30 days of first
marketing your product;11 and
11
Please note that the notification requirement for structure/function claims under 21 CFR 101.93 is
completely different than the notification requirements for new dietary ingredients under DSHEA. New
dietary ingredients are discussed in Chapter 4.
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(d) the claim must include a mandatory disclaimer statement.

i. Substantiation
Substantiation is a massive topic, which will be addressed in another article.
ii. Notification to the FDA
Within 30 days of the first marketing of a dietary supplement that has a
structure/function claim, you must notify the FDA in writing that such a statement is on the
label or in the labeling of your product.
The notification must include:
(i) The name and address of the manufacturer, packer, or distributor of the dietary
supplement that bears the statement;
(ii) The text of the statement that is being made;
(iii) The name of the dietary ingredient or supplement that is the subject of the
statement (if it is not provided within the text of the statement); and
(iv) The name of the dietary supplement (including brand name).
The notice must be signed by a responsible individual or the person who can certify the
accuracy of the information presented and contained in the notice. The individual must
certify that the information contained in the notice is complete and accurate, and that the
notifying firm has substantiation that the statement is truthful and not misleading.
You must mail the notice to:
Office of Nutritional Products
Labeling and Dietary Supplements (HFS-810)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, Maryland 20740
You must submit an original and two copies. All of these details are set forth in 21 CFR
101.93.
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iii. The Disclaimer

Youve seen this disclaimer all over the place. It is the one that is contained in a box
on the label of most dietary supplements.
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.
If there is only one statement of nutritional support (a structure/function claim) the
disclaimer should be the one above.
If there is more than one statement of nutritional support on the label or in the
labeling, each statement shall bear the disclaimer, or a plural disclaimer may used.
These statements have not been evaluated by the
Food and Drug Administration. This product is not
intended to diagnose, treat, cure, or prevent any
disease.
(1) Placement
The disclaimer must be either:
(A) placed adjacent to the statement with no intervening material; or
(B) linked to the statement with a symbol (e.g., an asterisk) at the end of
each such statement that refers to the same symbol placed adjacent to the
disclaimer specified in paragraphs (c)(1) or (c)(2) of this section.
On product labels and in labeling (e.g., web pages, pamphlets, catalogs), the disclaimer
must appear on each panel or web page where there such is a statement. The disclaimer
must be set off in a box where it is not adjacent to the statement in question.
(2) Type Size
The disclaimer must be in boldface type in letters of a type size no smaller than
one-sixteenth inch.
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b. How Do I Know Whether I Am Making a Structure/Function Claim or a Disease

Claim?
You may be wondering, How can I know whether a claim is a structure/function
claim or a disease12 claim?
Thats a great question!
The FDAs response is:
It may not be possible always to draw a bright line between structure/function
and disease claims. You should look at the objective evidence in your
labeling to assess whether a claim explicitly or implicitly is a disease claim.
For example, a statement may not mention a disease but may refer to
identifiable characteristic signs or symptoms of a disease such that the
intended use of the product to treat or prevent the disease may be inferred.
It is important that you keep in mind two things. First, the context of the
statement, decided from information on the label and in other labeling, will
determine if the statement is considered to be a disease claim. Second,
dietary supplements may not bear disease claims, explicit or implied, unless
the claim has undergone pre-market review by FDA and has been authorized
or approved under the rules for health claims or drugs, as appropriate. To
assist you in deciding whether a claim is or isn't a disease claim, the new
regulation contains a definition for disease, and then includes 10 criteria
intended to help clarify the types of claims that may be made for dietary
supplements without prior authorization or approval by FDA. We are
providing that disease definition and an explanation of the 10 criteria below.
The ten criteria for disease claims have already been addressed above in the article
regarding Claims That CANNOT Be Made For Dietary Supplements.
12
Remember that disease is defined as
[d]amage 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); except that diseases resulting from essential nutrient deficiencies (e.g.,
scurvy, pellagra) are not included in this definition.
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4. Statements of General Well-Being (These are Moderately Sexy)

There is really no rocket science to making a proper statement of general wellbeing. As the name suggests, they are statements of general well-being.
Unfortunately, our good friends at the FDA provide zero guidance on this type of
statement. Examples of statements of general well-being include:
I feel better than I ever have.
I feel 20 years younger.
I have more energy, and I can play with my grandchildren all day long.
Everything about me feels fantastic and works better than it ever has!
One thing you cannot do is attempt to tie a statement of general well-being to a
disease. For example, the claim promotes general well-being during the cold and flu
season is a drug claim. The FDA has already slammed that one. (See FDA Warning
Letter to Natures Way Products, dated March 13, 1998, and FDA Warning Letter to Rexall
Sundown, dated March 13, 1998.)
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