Threat from FDA Action- Alpha Omega Labs & Cansema - FDA website

[Guest guest]

I crawled all over the FDA website this morning, and this is what I

found concerning cliams and labeling for dietary supplements. Seems

to me that there could be a way to work within their own framework to

be able to advertise dietary supplements.

 

" Conventional Foods and Dietary Supplements

Claims that can be used on food and dietary supplement labels fall

into three categories: health claims, nutrient content claims, and

structure/function claims. The responsibility for ensuring the

validity of these claims rests with the manufacturer, FDA, or, in the

case of advertising, with the Federal Trade Commission.

 

I. Health Claims

Health claims describe a relationship between a food, food component,

or dietary supplement ingredient, and reducing risk of a disease or

health-related condition. There are three ways by which FDA exercises

its oversight in determining which health claims may be used on a

label or in labeling for a food or 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 careful review of the scientific evidence

submitted in health claim petitions; 2) the 1997 Food and Drug

Administration Modernization Act (FDAMA) provides for health claims

based on an authoritative statement of a scientific body of the U.S.

government or the National Academy of Sciences; such claims may be

used after submission of a health claim notification to FDA; and 3)

the 2003 FDA Consumer 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 an authorizing regulation. Such health claims must be

qualified to assure accuracy and non-misleading presentation to

consumers. The differences between these three methods of oversight

for health claims are summarized below. Appendix C of The Food

Labeling Guide contains a summary of those health claims that have

been approved for use on food and dietary supplement labels:

http://www.cfsan.fda.gov/~dms/flg-6c.html.

 

A " health claim " by definition has two essential components: (1) a

substance (whether 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. For example, statements that address a role of dietary

patterns or of general categories of foods (e.g., fruits and

vegetables) in health are considered to be dietary guidance rather

than health claims, provided that the context of the statement does

not suggest that a specific substance is the subject. Dietary

guidance statements used on food labels must be truthful and non-

misleading. 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. Structure/function claims

may not explicitly or implicitly link the relationship to a disease

or health related condition. Unlike health claims, dietary guidance

statements and structure/function claims are not subject to FDA

review and authorization. There are some regulatory requirements

associated with the use of structure/function claims; see

http://www.cfsan.fda.gov/~dms/labstruc.html.

 

NLEA Authorized Health Claims. The Nutrition Labeling and Education

Act (NLEA) of 1990, the Dietary Supplement Act of 1992, and the

Dietary Supplement Health and Education Act of 1994 (DSHEA), provide

for health claims used on labels that characterize a relationship

between a food, a food component, dietary ingredient, or dietary

supplement and risk of a disease (for example, " diets high in calcium

may reduce the risk of osteoporosis " ), provided the claims meet

certain criteria and are authorized by an FDA regulation. FDA

authorizes these types of health claims based on an extensive review

of the scientific literature, generally as a result of the submission

of a health claim petition, using the significant scientific

agreement standard to determine that the nutrient/disease

relationship is well established. For an explanation of the

significant scientific agreement standard, see:

http://www.cfsan.fda.gov/~dms/ssaguide.html.

 

Health Claims Based on Authoritative Statements. The Food and Drug

Administration Modernization Act of 1997 (FDAMA) provides a second

way for the use of a health claim on 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. FDA has prepared a guide on how a firm

can make use of authoritative statement-based health claims. This

guide can be found at: http://www.cfsan.fda.gov/~dms/hclmguid.html.

FDAMA does not include dietary supplements in the provisions for

health claims based on authoritative statements. Consequently, this

method of oversight for health claims cannot be used for dietary

supplements at this time. Examples of health claims based on

authoritative statements may also be found at:

http://www.cfsan.fda.gov/~dms/flg-6c.html.

 

Qualified Health Claims. FDA's 2003 Consumer Health Information for

Better Nutrition Initiative provides for 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 well enough established to meet the significant scientific

agreement standard required for FDA to issue an authorizing

regulation. 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. 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 the petitioner requesting the

qualified health claim, the qualified claims are available for use on

any food or dietary supplement product meeting the enforcement

discretion conditions specified in the letter. FDA has prepared a

guide on interim procedures for qualified health claims and on the

ranking of the strength of evidence supporting a qualified claim,

see: http://www.cfsan.fda.gov/~dms/hclmgui3.html. Qualified health

claim petitions that are submitted to FDA will be available for

public review and comment. A listing of petitions open for public

comment is at the FDA Dockets Management website. A summary of the

qualified health claims authorized by FDA may be found at:

http://www.cfsan.fda.gov/~dms/qhc-sum.html. For more information on

Qualified Health Claims, see http://www.cfsan.fda.gov/~dms/lab-

qhc.html.

 

II. Nutrient Content Claims

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 not comply with the claim. Most nutrient content claim

regulations apply only to those nutrients or dietary substances that

have an established daily value: http://www.cfsan.fda.gov/~dms/flg-

7a.html. 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 and are thus

meaningful to consumers. 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): http://www.cfsan.fda.gov/~lrd/cf101-13.html.) A

summary of the rules for use of nutrient content claims can be found

in Chapter VI of The Food Labeling Guide:

http://www.cfsan.fda.gov/~dms/flg-toc.html. Examples of nutrient

content claims can be found in Appendices A and B of The Food

Labeling Guide: http://www.cfsan.fda.gov/~dms/flg-6a.html and

http://www.cfsan.fda.gov/~dms/flg-6b.html.

 

III. Structure/Function Claims

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 supplement labels. 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 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. 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. The manufacturer is responsible for ensuring

the accuracy and truthfulness of these claims; they are not pre-

approved by FDA but must be truthful and not misleading. If a dietary

supplement label includes such a claim, it must state in

a " disclaimer " that FDA has not evaluated the claim. The disclaimer

must also state that the dietary supplement product is not intended

to " diagnose, treat, cure or prevent any disease, " because only a

drug can legally make such a claim. Further information regarding

structure/function claims can be found in FDA's January 9, 2002

Structure/Function Claims Small Entity Compliance Guide:

http://www.cfsan.fda.gov/~dms/sclmguid.html. Manufacturers of dietary

supplements that make structure/function claims on labels or in

labeling must submit a notification to FDA no later than 30 days

after marketing the dietary supplement that includes the text of the

structure/function claim.

 

 

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This document was issued on March 20, 2001 and revised October 2001

and September 2003.

For more recent information on Dietary Supplements

See http://www.cfsan.fda.gov/~dms/supplmnt.html