fda regulations in ful

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Damage to an organ, part, structure, or system of the body such that it

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does not function properly (e.g., cardiovascular disease), or a state of

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health leading to such as (e.g., hypertension); except that diseases =

resulting from essential nutrient deficiencies (e.g., scurvy, pellagra)

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are not included in this definition. " [emphasis added].=20

 

It was this issue of the expansion of the meaning of disease to include

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conditions that did not constitute damage to the body or an organ that =

 

concerned many consumers and industry members, motivating the large =

number of letters to the agency protesting the proposed definition. =

Under DSHEA, DS " intended for use in the diagnosis, cure, mitigation, =

treatment or prevention of disease " are considered drugs; by proposing =

 

to expand the definition of disease, FDA automatically would reduce the

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range or number of those claims under DSHEA. The final rule lays out a

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series of disease- or health-related conditions and how they will be =

regulated. FDA also offers important perspectives on collateral issues,

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most of which are summarized in the body of this article.=20

 

Effect on Disease or Class of Diseases. Under the old proposal, a =

statement would be considered a disease claim if it explicitly or =

implicitly claimed an effect on a specific disease or class of diseases.

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FDA included these examples of disease claims: (1) Express Claims: =

" Protective against the development of cancer " ; " reduces the pain and =

stiffness associated with arthritis " ; " decreases the effects of alcohol

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intoxication " ; " alleviates constipation. " (2) Implied Claims: " Helps =

promote urinary tract health " ; " helps maintain cardiovascular function =

 

and a healthy circulatory system " ; " helps maintain intestinal flora " ; =

" promotes relaxation. " =20

 

In a development that will surely result in new product marketing for =

herbal products, FDA has stated that certain constipation claims should

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not be treated as disease claims. Therefore, " For relief of occasional

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constipation " would not be considered a disease claim. The labeling of a

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product that claimed to treat occasional constipation should make clear,

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however, that the product is not intended to be used to treat chronic =

constipation, which may be a symptom of a serious disease.=20

 

Signs or Symptoms of Disease. Under the new rules FDA may look to =

medical texts and other objective sources of information about disease =

 

to determine whether a label implies treatment or prevention of disease

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by listing the characteristic signs and symptoms of a disease or class =

 

of diseases, whether they are printed in technical or lay language. This

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standard will focus on whether the labeling suggests that the product =

will produce a change in a set of one or more signs or symptoms =

characteristic of the disease. Example #1: FDA would not interpret =

" improves absentmindedness " as implying treatment of Alzheimer's =

disease, because absentmindedness is not as serious as the type of =

memory loss usually suffered by Alzheimer's patients. Example #2: FDA =

believes " inhibits platelet aggregation " is an implied disease =

treatment/prevention claim. Inhibiting or decreasing platelet =

aggregation is a well-recognized therapy for the prevention of stroke =

and recurrent heart attack and is the mechanism of action of a number of

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drug products approved for the treatment of stroke and heart attack. =

Thus, the agency would consider a claim to inhibit normal platelet =

function to be an implied claim to treat and prevent these disease =

conditions. Example #3: FDA believes " joint pain " is characteristic of =

 

arthritis. The Merck Manual notes joint tenderness as the most sensitive

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physical sign of rheumatoid arthritis. The claim " helps support =

cartilage and joint function " is, however, acceptable because it relates

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to maintaining normal function rather than treating joint pain. Another

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example: Labeling claiming a product " prevents bone fragility in =

post-menopausal women " clearly implies that the product prevents =

osteoporosis and thus is an unacceptable disease claim.=20

 

Effects on Abnormal Conditions Associated with a Natural State or =

Process. FDA believes that many claims concerning the maintenance of =

" normal " or " healthy " structure or function do not apply to disease =

prevention in the context of DS labeling unless other statements or =

pictures in the labeling imply prevention of a specific disease or class

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of diseases. Statements should not be made that products restore normal

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or correct abnormal function when the abnormality implies the presence =

 

of disease. Example #1: a claim to " restore " normal blood pressure when

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the abnormality implies hypertension. Example #2: " maintains healthy =

lungs in smokers " would imply prevention of tobacco-related lung cancer;

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however, " maintains healthy lung function " alone is an acceptable SF =

claim. Example #3 deals with a major area of herbal supplements: =

cholesterol levels. A claim that a DS helps maintain cholesterol levels

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that are already within the normal range does not necessarily imply =

disease treatments. FDA has concluded, however, that references to =

" healthy " cholesterol may be misleading to consumers. FDA continues to =

 

believe that " lowered cholesterol, " however qualified, is an implied =

disease claim. FDA will review all cholesterol claims to determine =

whether the labeling as a whole implies that the product is intended to

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lower elevated cholesterol levels; in such cases, FDA will consider the

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labeling to create an implied disease claim. FDA has concluded that an =

 

appropriate SF claim for maintaining cholesterol would be, " helps to =

maintain cholesterol levels that are already within the normal

range. " =20

 

Conditions Associated with Natural States. In its April 1998 notice, =

FDA had proposed to treat abnormal conditions such as toxemia of =

pregnancy, premenstrual syndrome, hot flashes, presbyopia, decreased =

sexual function, and Alzheimer's disease associated with aging as =

disease states. FDA has reconsidered this position and has concluded =

that it is not appropriate under DSHEA to treat certain common =

non-serious conditions associated with natural states as diseases. =

There are a wide variety of conditions representing impaired function of

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an organ or system that are associated with particular states of life or

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normal physiologic processes, including adolescence, the menstrual =

cycle, pregnancy, menopause and aging. Thus, mild conditions commonly =

associated with particular stages of life or normal physiological =

processes will not be considered diseases. However, a statement will be

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considered a disease claim if it claims that the product " has an effect

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on an abnormal condition associated with a natural state or process, if

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the abnormal condition is uncommon or can cause significant or permanent

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harm. " Ordinarily, FDA agrees that conditions associated with a stage of

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life or a normal physiological process are considered common if they =

occur in more than one half of those experiencing that stage or process.

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In a ruling that will have significant impact on the herb industry, FDA

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has stated that benign prostatic hyperplasia (BPH) should not be =

considered a consequence of aging. Even if BPH were considered a direct

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consequence of aging, claims to treat or prevent it would still be =

treated as disease claims, because failure to obtain effective treatment

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can cause significant or permanent harm. Consequently, " Helps to =

maintain normal urine flow in men over 50 years old, " is considered an =

 

implied disease claim. The average or normal state in men over 50 years

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old is diminishing urine flow, in most cases due to BPH, so that the =

apparent " maintenance " really represents a claim of improvement =

(treatment).=20

 

Examples of allowed claims are shown in Table 1. Disallowed claims are =

 

shown in Table 2; these remain disease claims.=20

 

Effects on a Disease or Diseases Through One or More of the Following =

Factors

 

Name of the Product. The proposed rule argued that a statement would be

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considered a disease claim if it claimed explicitly or implicitly to =

have an effect on diseases through one or more factors including the =

name of the product. Examples include: Carpaltum (carpal tunnel =

syndrome); Raynaudin (Raynaud's phenomenon); Hepatacure (liver =

problems). Acceptable names suggested were Cardiohealth and Heart Tabs.

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Under the final rule ads could be called " Heart Tabs " if the claim was =

 

to " maintain healthy circulation " or some other role related to the =

structure/function of the heart that did not imply treatment or =

prevention of disease. If, however, the product name was not qualified =

 

by any further claim on the labeling, the product would be considered as

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treatment or prevention of cardiovascular disease. The name of a product

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should not contain the name or recognizable portion of a name of a =

disease. Also, the name should not use terms such as " cure, treat, =

correct, prevent " or other terms that suggest treatment or prevention of

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disease. Thus, Carpalhealth and Circucare would be considered disease =

 

claims. " Soothing sleep " could be considered a claim to treat insomnia

 

 

 

 

 

 

 

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