Claims That CAN Be Made for Dietary Supplements

The Secret of Making ProperStructure/Function ClaimsBY THE FDA AND FTC

HOW NOT TO GET TARGETED

PAGE 1 2014 KEVIN D. GRIMES [email protected] (615) 465-6000

Claims That CAN Be MadeFor 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 dietaryingredient, and reducing risk of a disease or health-related condition.

Youre probably thinking, Hmmm . . . reducing the risk of a disease sure sounds likea disease prevention claim. Youre right! It really is, which would normally make sucha 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 (afood, 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 definitionof a health claim. Statements that address a role of a specific substance in maintainingnormal healthy structures or functions of the body are considered to be structure/functionclaims.

There are three different types of health claims that may be used on a label or inlabeling 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 dietarysupplements after FDA's review of the scientific evidence submitted in health claimpetitions [I will call this category of health claim a regular health claim ]; (2) the 1997 Foodand Drug Administration Modernization Act (FDAMA) provides for health claims forconventional 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 HealthInformation for Better Nutrition Initiative provides for qualified health claims where thequality and strength of the scientific evidence falls below that required for FDA to issue aregulation to authorize a regular health claim. Qualified health claims must be qualifiedto assure accuracy and non-misleading presentation to customers.




a. Currently Approved Health Claims1

You will find below all of the health claims that the FDA has authorized byregulation. Some of them are not relevant to dietary supplements, and thus, I will notdiscuss 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 andcancer 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 theseclaims for your product . . . but then again, you might be. Thus, in the interest of providingyou 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

1 There are other health claims authorized by regulation, however, they are applicable only toconventional 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 HeartDisease (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 fromCertain Foods and Risk of Coronary Heart Disease (21 CFR 101.81), Soy Protein and Risk of Coronary HeartDisease (21 CFR 101.82).




(a) Model Health Claim 1 Adequate calcium throughout life, as part of awell-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 ahealthful diet, along with physical activity, may reduce the risk ofosteoporosis 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 articulatedin 21 CFR 101.72(d).

ii. Fiber-containing Grain Products, Fruits, Vegetables, and Cancer (21 CFR101.76)

(1) Model Health Claims for Grain Products, Fruits, Vegetables, and Cancer

(a) Model Health Claim 1 Low fat diets rich in fiber-containing grainproducts, 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 manyfactors. Eating a diet low in fat and high in grain products, fruits, andvegetables that contain dietary fiber may reduce your risk of some cancers.

(2) Requirements (there arent very many) are all set forth in 21 CFR101.76(c).





iii. Fruits, Vegetables, and Grain Products That Contain Fiber, ParticularlySoluble Fiber, and Risk of Coronary Heart Disease (21 CFR 101.77)

(1) Model Health Claims for Fruits, Vegetables, and Grain Products ThatContain Fiber, Particularly Soluble Fiber, and Risk of Coronary HeartDisease

(a) Model Health Claim 1 Diets low in saturated fat and cholesterol andrich in fruits, vegetables, and grain products that contain some types ofdietary 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 manyfactors. Eating a diet low in saturated fat and cholesterol and high in fruits,vegetables, and grain products that contain fiber may lower blood cholesterollevels and reduce your risk of heart disease.

(2) Requirements are all set forth in 21 CFR 101.77(c).


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 (foodsthat 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 withmany factors. Broccoli is high in vitamins A and C, and it is a good source ofdietary fiber.

(b) Model Health Claim 2 Development of cancer depends on manyfactors. Eating a diet low in fat and high in fruits and vegetables, foods thatare low in fat and may contain vitamin A, vitamin C, and dietary fiber, mayreduce your risk of some cancers. Oranges, a food low in fat, are a goodsource of fiber and vitamin C.

(2) Requirements are all set forth in 21 CFR 101.78(c).





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 containing100 percent or less of the DV for folate per serving or per unit; this examplecontains only the required elements) Healthful diets with adequate folatemay reduce a woman's risk of having a child with a brain or spinal cord birthdefect.

(b) Model Health Claim 2 (a model health claim for products containing100 percent or less of the DV for folate per serving or per unit; this examplecontains only the required elements) Adequate folate in healthful diets mayreduce a woman's risk of having a child with a brain or spinal cord birthdefect.

(c) Model Health Claim 3 (a model health claim for products containing100 percent or less of the DV for folate per serving or per unit; this examplecontains all required elements plus optional information) -- Women whoconsume healthful diets with adequate folate throughout their childbearingyears may reduce their risk of having a child with a birth defect of the brainor spinal cord. Sources of folate include fruits, vegetables, whole grainproducts, fortified cereals, and dietary supplements.

(d) Model Health Claim 4 (a model health claim for products containingmore than 100 percent of the DV of folate per serving or per unit) Womenwho consume healthful diets with adequate folate may reduce their risk ofhaving a child with birth defects of the brain or spinal cord. Folate intakeshould not exceed 250% of the DV (1,000 mcg).

(2) Requirements There are a bunch, and they are set forth in 21 CFR101.79(c)(1) - (2), which you will find in Appendix 17.

(3) Optional Information The optional information you may include in afolate/neural tube defect claim is set forth in 21 CFR 101.79(c)(3).




vi. Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease (21CFR 101.81)


(a) Model Health Claim 1 Soluble fiber from foods such as [name ofsoluble fiber source and, if desired, the name of food product], as part of adiet low in saturated fat and cholesterol, may reduce the risk of heartdisease. A serving of [name of product] supplies ____ grams of the [gramsof 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 thatinclude [____ grams of soluble fiber] of soluble fiber per day from [name ofsoluble fiber source and, if desired, the name of the product] may reduce therisk of heart disease. One serving of [name of the product] provides ____grams of this soluble fiber.

(2) Requirements There are a bunch, and they are set forth in 21 CFR101.81(c).

(3) Optional Information The optional information you may include in a solublefiber/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 dietlow in saturated fat and cholesterol, may reduce the risk of heart disease. Aserving of [name of food] supplies __ grams of soy protein.

(b) Model Health Claim 2 Diets low in saturated fat and cholesterol thatinclude 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 soyprotein/coronary heart disease claim is set forth in 21 CFR 101.82(d)




viii. Plant Sterol/stanol esters and Risk of Coronary Heart Disease (21 CFR101.83)


(a) Model Health Claim 1 (For plant sterol esters) Foods containing atleast 0.65 g per serving of plant sterol esters, eaten twice a day with mealsfor a daily total intake of at least 1.3 g, as part of a diet low in saturated fatand cholesterol, may reduce the risk of heart disease. A serving of [name ofthe product] supplies ___grams of vegetable oil sterol esters.

(b) Model Health Claim 2 (For plant sterol esters) Diets low in saturatedfat and cholesterol that include two servings of foods that provide a daily totalof at least 1.3 g of vegetable oil sterol esters in two meals may reduce therisk of heart disease. A serving of [name of the product] supplies ___gramsof vegetable oil sterol esters.

(c) Model Health Claim 3 (For plant stanol esters) Foods containing atleast 1.7 g per serving of plant stanol esters, eaten twice a day with mealsfor a total daily intake of at least 3.4 g, as part of a diet low in saturated fatand cholesterol, may reduce the risk of heart disease. A serving of [name ofthe product] supplies ___grams of plant stanol esters.

(d) Model Health Claim 4 (For plant stanol esters) Diets low in saturatedfat and cholesterol that include two servings of foods that provide a daily totalof at least 3.4 g of vegetable oil stanol esters in two meals may reduce therisk of heart disease. A serving of [name of the product] supplies ___gramsof vegetable oil stanol esters.

(2) Requirements There are a bunch, and they are set forth in 21 CFR101.83(c) (Appendix 17).

(3) Optional Information The optional information you may include in a solublefiber/coronary heart disease claim is set forth in 21 CFR 101.83(d)




b. Health Claims Authorized Based on an Authoritative Statement by a ScientificBody2

The Food and Drug Administration Modernization Act of 1997 (FDAMA) providesa 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 toFDA of a health claim based on an "authoritative statement" from a scientific body of theU.S. Government or the National Academy of Sciences.

The FDAMA does not include dietary supplements in the provisions for health claimsbased on authoritative statements. Consequently, health claims based on authoritativestatements cannot be used for dietary supplements at this time. The FDA has said thatsomeday it intends to propose that health claims based on authoritative statements bepermitted 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 relationshipbetween a food, food component, or dietary supplement and reduced risk of a disease orhealth-related condition. In this case, the evidence is not strong enough to meet thesignificant scientific agreement standard required for the FDA to issue a regulation thatauthorizes a (full blown regular) health claim. Qualifying language is included as part ofthe claim to indicate that the evidence supporting the claim is limited. Both conventionalfoods and dietary supplements may use qualified health claims.

The FDA uses its enforcement discretion for qualified health claims afterevaluating 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 whorequests the qualified health claim, the qualified claims are available for use on any food

2 There are other health claims authorized based on an authoritative statement by a federal scientificbody, 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 andCertain 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 bemade for conventional foods. These include the cancer risk claims for tomatoes and/or tomato sauce forprostate, ovarian, gastric, and pancreatic cancers. Unfortunately, these claims can only be made for productsthat contain cooked, raw, dried, or canned tomatoes, and tomato sauces that contain at least 8.37 percentsalt-free tomato solids . . . which probably will not be a dietary supplement.




or dietary supplement product meeting the enforcement discretion conditions specified inthe letter.

The claims set forth below are the actual claims that you can (and must, if youchoose 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 riskof neural tube defects than a lower amount in foods in common form. FDAdoes not endorse this claim. Public health authorities recommend thatwomen consume 0.4 mg folic acid daily from fortified foods or dietarysupplements or both to reduce the risk of neural tube defects.

The disclaimer (i.e., FDA does not endorse this claim...) must be placed immediatelyadjacent to and directly beneath the claim (i.e., 0.8 mg folic acid ...), with no interveningmaterial, in the same size, typeface, and contrast as the claim.

Remember there also is a folic acid/neural tube defect health claim authorized byregulation (see 21 CFR 101.79).

ii. B Vitamins and Vascular Disease

This claim can be made for dietary supplements containing vitamin B6, B12, and/orfolic 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 vasculardisease. FDA evaluated the above claim and found that, while it is knownthat diets low in saturated fat and cholesterol reduce the risk of heart diseaseand other vascular diseases, the evidence in support of the above claim isinconclusive.

The disclaimer (i.e., FDA evaluated the above claim...) must be immediatelyadjacent to and directly beneath the first claim (i.e., As part of a well-balanced diet... ) withno intervening material that separates the claim from the disclaimer, and the secondsentence must be in the same size, type face and contrast as the first sentence.




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 safeupper limit of daily intake value of 1,000 micrograms (1 mg) may be included inparentheses.

Dietary supplements containing folic acid must meet the United StatesPharmacopeia (USP) standards for disintegration and dissolution, except that if there areno applicable USP standards, the folate in the dietary supplement shall be shown to bebioavailable 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 supplementscontaining selenium.

Selenium may reduce the risk of certain cancers. Some scientific evidencesuggests that consumption of selenium may reduce the risk of certain formsof cancer. However, FDA has determined that this evidence is limited andnot conclusive.

Selenium may produce anticarcinogenic effects in the body. Some scientificevidence suggests that consumption of selenium may produceanticarcinogenic effects in the body. However, FDA has determined that thisevidence is limited and not conclusive.

The disclaimer (i.e., Some scientific evidence suggests...) must be placedimmediately 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 ordinaryconditions of use, a daily intake exceeding the Tolerable Upper Intake Level establishedby the National Academy of Sciences/Institute of Medicine for selenium (400 microgramsper day). Dietary supplements bearing the claim(s) must meet the nutrient content claimdefinition for high (i.e., 20% or more of the daily value (DV) per RACC [Reference AmountsCustomarily 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/orvitamin C.




Some scientific evidence suggests that consumption of antioxidant vitaminsmay reduce the risk of certain forms of cancer. However, FDA hasdetermined that this evidence is limited and not conclusive.

Some scientific evidence suggests that consumption of antioxidant vitaminsmay reduce the risk of certain forms of cancer. However, FDA does notendorse this claim because this evidence is limited and not conclusive.

FDA has determined that although some scientific evidence suggests thatconsumption of antioxidant vitamins may reduce the risk of certain forms ofcancer, this evidence is limited and not conclusive.

The disclaimer (i.e., ...evidence is limited and not conclusive) must be placedimmediately adjacent to and below the claim, with no intervening material, in the samesize, 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 ordinaryconditions of use, a daily intake exceeding the Tolerable Upper Intake Levels establishedby the Institute of Medicine for vitamin C (2000 mg per day) or for vitamin E (1000 mg perday). Paragraph 101.14(d)(2)(vii) requires that the food bearing the claim meet the nutrientcontent 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-derivedphosphatidylserine.

Consumption of phosphatidylserine may reduce the risk of dementia in theelderly. Very limited and preliminary scientific research suggests thatphosphatidylserine may reduce the risk of dementia in the elderly. FDAconcludes that there is little scientific evidence supporting this claim.

Consumption of phosphatidylserine may reduce the risk of cognitivedysfunction in the elderly. Very limited and preliminary scientific researchsuggests that phosphatidylserine may reduce the risk of cognitivedysfunction in the elderly. FDA concludes that there is little scientificevidence supporting this claim.




The disclaimer (i.e., Very limited and preliminary scientific research...) must beplaced immediately adjacent to and directly beneath the claim (i.e., Phosphatidylserinemay reduce...), with no intervening material, in the same size, typeface, and contrast asthe claim itself.

The FDAs letter says, [t]he soy-derived phosphatidylserine used must be of veryhigh 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 thatcontain EPA and DHA omega-3 fatty acids.

Supportive but not conclusive research shows that consumption of EPA andDHA omega-3 fatty acids may reduce the risk of coronary heart disease. Oneserving of [name of the product] provides [__] gram of EPA and DHAomega-3 fatty acids. [See nutrition information for total fat, saturated fat, andcholesterol content.]4

Dietary supplements should not recommend or suggest in their labeling a dailyintake exceeding 2 grams of EPA and DHA.

Dietary supplements that weigh 5 g or less per RACC (which is an FDA abbreviationfor Reference Amounts Customarily Consumed) (RACC for dietary supplement is labeledserving size) are exempted from the total fat disqualifying level, but if dietary supplementsthat 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 beplaced immediately adjacent to the health claim. Dietary supplements that weigh morethan 5 g per RACC must not exceed the total fat disqualifying level (13.0 g per RACC andper 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 thesaturated fat content (1 g or less per RACC) but not with regard to the no more than 15percent calories from saturated fat criterion.

Dietary supplements that weigh 5 g or less per RACC are exempt from thecholesterol disqualifying level (60 mg per 50 g), but those that exceed the cholesteroldisqualifying level must include "See nutrition information for cholesterol content" with the

4 Dietary supplements may declare the amount of EPA and DHA per serving in "Supplement Facts,"instead of making the declaration in the claim.




health claim. Dietary supplements that weigh more than 5 g per RACC must meet thecriterion for low cholesterol (20 mg or less per 50g).

Dietary supplements must meet the sodium disqualifying level (480 mg or less perRACC 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 dietarysupplements that contain green tea.

Two studies do not show that drinking green tea reduces the risk of breastcancer in women, but one weaker, more limited study suggests that drinkinggreen tea may reduce this risk. Based on these studies, FDA concludes thatit is highly unlikely that green tea reduces the risk of breast cancer.

One weak and limited study does not show that drinking green tea reducesthe risk of prostate cancer, but another weak and limited study suggests thatdrinking green tea may reduce this risk. Based on these studies, FDAconcludes that it is highly unlikely that green tea reduces the risk of prostatecancer.

The product must not exceed the disqualifying nutrient levels for total fat, saturatedfat, cholesterol, and sodium specified in 21 CFR 101.14(a)(4). These levels are 13.0grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, or 480 mg ofsodium, per reference amount customarily consumed, per label serving size, and, only forfoods with reference amounts customarily consumed of 30 g or less or 2 tablespoons orless.

The product must also not exceed the 10% minimum nutrient content requirementin 21 CFR 101.14(e)(6). This means that a green tea product may not contain 10% ormore 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 ofinsulin resistance, and therefore possibly may reduce the risk of type 2diabetes. FDA concludes, however, that the existence of such a relationship




between chromium picolinate and either insulin resistance or type 2 diabetesis highly uncertain.

Dietary supplement containing chromium must meet or exceed the requirement fora "high" level of chromium as defined in 21 CFR 101.54(b) (i.e., 24 mg or more perreference amount customarily consumed under the current regulation).

ix. Cancer Risks Calcium and Colon/Rectal Cancer and Calcium andRecurrent Colon/Rectal Polyps

These claims can be made for dietary supplements containing more than 200 mgof calcium per reference amount customarily consumed.

(a) Claim Statement for Colon/Rectal Cancer

Some evidence suggests that calcium supplements may reduce the risk ofcolon/rectal cancer, however, FDA has determined that this evidence islimited and not conclusive.

(b) Claim Statement for Recurrent Colon Polyps

Very limited and preliminary evidence suggests that calcium supplementsmay reduce the risk of colon/rectal polyps. FDA concludes that there is littlescientific 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 fordisintegration and dissolution applicable to their component calcium salts.5 For dietarysupplements for which no U.S.P. standards exist, the dietary supplement must exhibitappropriate assimilability under the conditions of use stated on the product label.6

x. Calcium and Hypertension, Pregnancy-Induced Hypertension, andPreeclampsia

These claims can be made for dietary supplements containing calcium.

5 21 CFR 101.72(c)(ii)(B)

6 21 CFR 101.72(c)(ii)(C)




Some scientific evidence suggests that calcium supplements may reduce therisk of hypertension. However, FDA has determined that the evidence isinconsistent and not conclusive.

Four studies, including a large clinical trial, do not show that calciumsupplements reduce the risk of pregnancy-induced hypertension duringpregnancy. However, three other studies suggest that calcium supplementsmay reduce the risk. Based on these studies, FDA concludes that it is highlyunlikely that calcium supplements reduce the risk of pregnancy-inducedhypertension.

Three studies, including a large clinical trial, do not show that calciumsupplements 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 calciumsupplements reduce the risk of preeclampsia.

The dietary supplement must meet or exceed the requirement for a "high" level ofcalcium as defined in 21 CFR 101.54(b) (i.e., 200 mg or more calcium per referenceamount customarily consumed). The calcium content of the dietary supplement must beassimilable (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 mustexhibit 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 labelclaims that characterize the level of a nutrient in a food (i.e., nutrient content claims) madein accordance with FDA's authorizing regulations. Nutrient content claims describe thelevel 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, usingterms such as more, reduced, and lite. An accurate quantitative statement (e.g., 200mg of sodium) that does not "characterize" the nutrient level may be used to describe anyamount 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 thecriteria of an appropriate nutrient content claim or carry a disclosure statement that it does

7 21 CFR 101.72(c)(ii)(B).

8 21 CFR 101.72(c)(ii)(C).




not comply with the claim. Most nutrient content claim regulations apply only to thosenutrients or dietary substances that have an established daily value.

The requirements that govern the use of nutrient content claims help ensure thatdescriptive terms, such as high or low, are used consistently for all types of foodproducts. Healthy has been defined by a regulation as an implied nutrient content claimthat characterizes a food that has "healthy" levels of total fat, saturated fat, cholesterol andsodium.

Percentage claims for dietary supplements are another category of nutrient contentclaims. These claims are used to describe a percentage level of a dietary ingredient forwhich there is no established Daily Value. Examples include simple percentagestatements such as "40% omega-3 fatty acids, 10 mg per capsule," and comparativepercentage claims, e.g., "twice the omega-3 fatty acids per capsule (80 mg) as in 100 mgof 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% ormore 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 mustcontain 10% or more of the DV per RACC. These terms may only be used forvitamins, minerals, protein, dietary fiber, and potassium.

iv. "High Potency" May be used on foods to describe individual vitamins orminerals that are present at 100% or more of the RDI per RACC or on amulti-ingredient food product that contains 100% or more of the RDI for at least2/3 of the vitamins and minerals with RDIs and that are present in the productat 2% or more of the RDI (e.g., "High potency multivitamin, multi-mineral dietarysupplement tablets").

v. Claims using the term "antioxidant" For claims characterizing the level ofantioxidant 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;




(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 ofvitamin A present as beta-carotene in the food is sufficient to qualify for theclaim.

3. Structure/Function Claims (These are Ultra Dead Sexy!)

Structure/function claims have historically appeared on the labels of conventionalfoods and dietary supplements as well as drugs. However, the Dietary Supplement Healthand Education Act of 1994 (DSHEA) established some special regulatory procedures forsuch claims for dietary supplements. Structure/function claims describe the role of anutrient or dietary ingredient intended to affect normal structure or function in humans,for example, "calcium builds strong bones." In addition, they may characterize the meansby which a nutrient or dietary ingredient acts to maintain such normal structure orfunction, for example, "fiber maintains bowel regularity," or "antioxidants maintain cellintegrity," or they may describe general well-being from consumption of a nutrient or dietaryingredient.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 dietarysupplements without prior review by the FDA.10 Called structure/function claims, theseclaims are statements that describe the effect a dietary supplement may have on thestructure or function of the body. More precisely, the Dietary Supplement Health andEducation Act defines a structure/function claim as one that:

(1) describes the role of a nutrient or dietary ingredient intended to affect thestructure or function in humans, or(2) characterizes the documented mechanism by which a nutrient or dietaryingredient acts to maintain such structure or function.

The regulation also articulates when a statement about a dietary supplement is a diseaseclaim (that is, a claim to diagnose, cure, mitigate, treat, or prevent disease), which hasalready been addressed in Chapter 8. As we have already discussed, disease claims

9 Structure/function claims may also describe a benefit related to a nutrient deficiency disease (likevitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the UnitedStates.

10 65 Federal Register 1000.




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 foodsthat are "health claims" (see above). Unlike health claims, structure/function claims are notsubject to FDA review and authorization.

Section 101.93(f) provides:

(f) Permitted structure/function statements. Dietary supplement labels orlabeling may, subject to the requirements in paragraphs (a) through (e) ofthis section, bear statements that describe the role of a nutrient or dietaryingredient intended to affect the structure or function in humans or thatcharacterize the documented mechanism by which a nutrient or dietaryingredient acts to maintain such structure or function, provided that suchstatements are not disease claims under paragraph (g) of this section. If thelabel or labeling of a product marketed as a dietary supplement bears adisease claim as defined in paragraph (g) of this section, the product will besubject to regulation as a drug unless the claim is an authorized health claimfor which the product qualifies.

According to the FDA, structure/function claims may not explicitly or implicitly linkthe 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 sameplace!

a. Requirements

There are four requirements you must meet to make structure/function claims. Youmust:

(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 firstmarketing your product;11 and

11 Please note that the notification requirement for structure/function claims under 21 CFR 101.93 iscompletely different than the notification requirements for new dietary ingredients under DSHEA. Newdietary ingredients are discussed in Chapter 4.




(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 astructure/function claim, you must notify the FDA in writing that such a statement is on thelabel or in the labeling of your product.

The notification must include:

(i) The name and address of the manufacturer, packer, or distributor of the dietarysupplement 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 thestatement (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 theaccuracy of the information presented and contained in the notice. The individual mustcertify that the information contained in the notice is complete and accurate, and that thenotifying firm has substantiation that the statement is truthful and not misleading.

You must mail the notice to:

Office of Nutritional ProductsLabeling and Dietary Supplements (HFS-810)Center for Food Safety and Applied NutritionFood and Drug Administration5100 Paint Branch ParkwayCollege Park, Maryland 20740

You must submit an original and two copies. All of these details are set forth in 21 CFR101.93.




iii. The Disclaimer

Youve seen this disclaimer all over the place. It is the one that is contained in a boxon the label of most dietary supplements.

If there is only one statement of nutritional support (a structure/function claim) thedisclaimer should be the one above.

If there is more than one statement of nutritional support on the label or in thelabeling, each statement shall bear the disclaimer, or a plural disclaimer may used.

(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 ofeach such statement that refers to the same symbol placed adjacent to thedisclaimer specified in paragraphs (c)(1) or (c)(2) of this section.

On product labels and in labeling (e.g., web pages, pamphlets, catalogs), the disclaimermust appear on each panel or web page where there such is a statement. The disclaimermust 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 thanone-sixteenth inch.

This statement has not been evaluated by the Foodand Drug Administration. This product is not intendedto diagnose, treat, cure, or prevent any disease.

These statements have not been evaluated by theFood and Drug Administration. This product is notintended to diagnose, treat, cure, or prevent anydisease.




b. How Do I Know Whether I Am Making a Structure/Function Claim or a DiseaseClaim?

You may be wondering, How can I know whether a claim is a structure/functionclaim 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/functionand disease claims. You should look at the objective evidence in yourlabeling to assess whether a claim explicitly or implicitly is a disease claim.For example, a statement may not mention a disease but may refer toidentifiable characteristic signs or symptoms of a disease such that theintended 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 thestatement, decided from information on the label and in other labeling, willdetermine if the statement is considered to be a disease claim. Second,dietary supplements may not bear disease claims, explicit or implied, unlessthe claim has undergone pre-market review by FDA and has been authorizedor approved under the rules for health claims or drugs, as appropriate. Toassist you in deciding whether a claim is or isn't a disease claim, the newregulation contains a definition for disease, and then includes 10 criteriaintended to help clarify the types of claims that may be made for dietarysupplements without prior authorization or approval by FDA. We areproviding that disease definition and an explanation of the 10 criteria below.

The ten criteria for disease claims have already been addressed above in the articleregarding 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 functionproperly (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.




4. Statements of General Well-Being (These are Moderately Sexy)

There is really no rocket science to making a proper statement of general well-being. As the name suggests, they are statements of general well-being.

Unfortunately, our good friends at the FDA provide zero guidance on this type ofstatement. 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 adisease. For example, the claim promotes general well-being during the cold and fluseason is a drug claim. The FDA has already slammed that one. (See FDA WarningLetter to Natures Way Products, dated March 13, 1998, and FDA Warning Letter to RexallSundown, dated March 13, 1998.)

Health Claims Currently Approved Health ClaimsCalcium, Vitamin D, and Osteoporosis Fiber-containing Grain Products, Fruits, Vegetables, and Cancer (21 CFR 101.76) Fruits, Vegetables, and Grain Products That Contain Fiber, Particularly Soluble Fiber, and Risk of Coronary Heart Disease (21 CFR 101.77) Fruits, Vegetables, and Cancer (21 CFR 101.78) Folate and Neural Tube Defects Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease Soy Protein and Risk of Coronary Heart Disease Plant Sterol/stanol esters and Risk of Coronary Heart Disease

Health Claims Authorized Based on an Authoritative Statement by a Scientific BodyQualified Health Claims0.8 mg Folic Acid & Neural Tube Birth DefectsB Vitamins and Vascular DiseaseCancer Risks Selenium and CancerAntioxidant Vitamins and CancerPhosphatidylserine and Cognitive Dysfunction and DementiaOmega-3 Fatty Acids and Coronary Heart DiseaseCancer Risks Green Tea and CancerChromium Picolinate and DiabetesCancer Risks Calcium and Colon/Rectal Cancer and Calcium and Recurrent Colon/Rectal PolypsCalcium and Hypertension, Pregnancy-Induced Hypertension, and Preeclampsia

Nutrient Content Claims Structure/Function Claims RequirementsSubstantiationNotification to the FDAThe Disclaimer

How Do I Know Whether I Am Making a Structure/Function Claim or a Disease Claim?

Statements of General Well-Being

Documents

Claims That CAN Be Made for Dietary Supplements