FDA Rules part 3

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Specific Claims Not Mentioned in the Proposed Rule. FDA allows that =

some minor pain relief claims may be appropriate SF claims for DS. A =

claim that a product is intended to treat minor pain without referring =

 

to other conditions, symptoms, or parts of the body that would imply =

disease treatment or prevention would be acceptable SF claims, because =

 

minor pain by itself can be caused by a variety of conditions, not all =

 

of them disease related. FDA did not, however, agree that general =

well-being or health maintenance claims would encompass such pain =

claims. Pain is not a normal state, nor are there " normal pain levels. "

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While the claim to maintain or support joints is appropriate, use of the

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claim in conjunction with a name that includes the term " pain " renders =

 

this a disease claim. Acceptable SF claims could be made, however, for =

 

pain associated with non-disease states (e.g., muscle pain following =

exercise).=20

 

In other areas, FDA said that the statements, " boosts stamina, helps =

increase muscle size, helps enhance muscle tone " are acceptable SF =

claims because they do not refer to any disease. " Deters bacteria from

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adhering to the wall of the bladder and urinary tract " is not =

acceptable, as it implies prevention of bacterial infection. The claim,

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" dietary support during the cold and flu season " and " promotes general =

 

well-being during the cold and flu season " are disease claims and are =

not acceptable, i.e., the products will prevent colds or flu or will =

mitigate the symptoms of those diseases. FDA agrees that certain smoking

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alternative claims may be acceptable if they do not imply treatment of =

 

nicotine addiction. " Smoking alternative, " " temporarily reduces your =

desire to smoke " and " mimics the oral sensations of cigarette smoke " may

=

be acceptable if the context does not imply treatment of nicotine =

addiction.=20

 

Allowance of Some OTC Drug Claims. In an important ruling that might =

result in the blurring of the line between a DS and an OTC drug, FDA =

agreed that inclusion of a claim in an OTC monograph does not preclude =

 

its use as an SF claim; FDA agrees that some OTC drug claims may be =

acceptable SF claims, but others are disease claims. Examples: Relief of

=

sour stomach and upset stomach (from the OTC antacid monograph) are =

acceptable SF claims because they refer to nonspecific groups of =

conditions that are not disease related. Occasional heartburn and =

occasional acid indigestion can also be considered nonspecific symptoms

=

and therefore appropriate SF claim areas. By contrast, recurrent or =

persistent heartburn and acid indigestion can be signs of significant =

illness and are therefore disease claims. " Alleviates the symptoms =

referred to as gas, " " alleviates bloating, " " alleviates pressure, " =

" alleviates fullness, " and " alleviates stuffed feeling " are all =

acceptable SF claims (OTC anti-gas monograph). " For the prevention and =

 

treatment of the nausea, vomiting and/or dizziness associated with =

motion " is a permitted SF claim (anti-emetic monograph). " For the relief

=

of occasional sleeplessness " is acceptable (nighttime sleep aid =

monograph). " Helps you fall asleep if you have difficulty falling =

asleep, " or " helps to reduce difficulty falling asleep " are disease =

claims as they imply treatment of insomnia, a disease. " Helps restore =

mental alertness or wakefulness when experiencing fatigue or drowsiness "

=

is acceptable (alertness aids monograph) because occasional fatigue and

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drowsiness are not characteristic symptoms of a specific disease or =

class of diseases. Chronic fatigue or daytime drowsiness can be symptoms

=

of chronic fatigue syndrome or narcolepsy and are disease claims. =

" Occasional simple nervous tension, " " nervousness due to common, =

everyday overwork and fatigue, " " a relaxed feeling, " " calming down and =

 

relaxing, " " gently sooth away the tension, " " calmative, " " resolving that

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irritability that ruins your day, " " helps you relax, " " restlessness, " =

" nervous irritability, " " when you are under occasional stress " and =

" helps you work relaxed " are all acceptable SF claims, because all =

suggest occasional rather than long-term or chronic mood changes =

(daytime sedative monograph). " Nervous tension headache " is a disease =

claim, because tension headache meets the definition of disease. (See =

Table 3.)=20

 

" Arouses or increases sexual desire and improves sexual performance " is

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acceptable (aphrodisiacs monograph) because it does not imply treatment

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of a disease. " Helps restore sexual vigor, potency and performance, " =

" improves performance, staying power and sexual potency, " " builds =

virility and sexual potency " are disease claims because they use the =

term " potency " which implies treatment of impotence, a disease. If, =

however, these claims make clear that they are intended solely for =

increased sexual function associated with aging, they could be =

acceptable SF claims.=20

 

To relieve the symptoms of benign prostatic hypertrophy, e.g., urinary =

 

urgency and frequency, " excessive urinating at night and delayed =

urination " is a disease claim because BPH meets the definition of =

disease. " Relieves excessive secretions of the nose and eyes " is a =

disease claim as it refers to the characteristic signs or symptoms of =

hay fever. " Digestive aid, " " stool softener, " " weight control " and =

" menstrual " are, by themselves, acceptable SF claims if the labeling =

does not otherwise imply treatment or prevention of disease. " Nasal =

decongestant, " " expectorants, " and " bronchodilator " are disease claims =

 

because nasal decongestant is a treatment for a characteristic symptom =

 

of colds, flu, and hay fever; expectorant is a treatment for a =

characteristic symptom of colds, flu and bronchitis; and bronchodilator

=

is a treatment for bronchospasm, a characteristic symptom of asthma. =

" Treatment and/or prevention of nocturnal leg muscle cramps, i.e., a =

condition of localized pain in the lower extremities usually occurring =

 

in middle life and beyond with no regular pattern concerning time or =

severity " is an appropriate SF claim (nocturnal leg muscle cramp =

monograph). Nocturnal leg cramps do not meet the definition of disease.

=

 

 

Regarding safety of DS making an allowed OTC claim, in a statement that

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is likely to increasingly obscure the line between a DS and an OTC drug,

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FDA also noted that in light of the statutory requirement that DS bear =

 

all information that is material in light of consequences that may =

result from use of the product or representations made about it, DS that

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contain or are labeled as containing ingredients covered by an OTC =

monograph and that are being sold for the claims covered by the =

monograph may be misbranded to the extent that they omit material =

information required under the monograph. That is, information on =

contraindications or potential adverse side effects required in an OTC =

 

drug monograph now appears to be required for a DS label if the product

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contains an ingredient approved as an OTC drug and is marketed as a DS =

 

for the same indication in the OTC drug monograph. For example, if the =

 

OTC monograph required a label statement that products containing a =

particular ingredient should not be used by a person taking a =

prescription MAO (monoamine oxidase) inhibitor, a DS containing that =

ingredient would be misbranded if its label did not include such

a statement.=20

 

Substantiation of Claims. FDA does not believe that the new rule is the

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appropriate venue to address substantiation requirements. The CDSL =

included guidance on what quantity and quality of evidence should be =

used to substantiate SF claims. The commission also provided guidance on

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the content of the substantiation files for such claims including the =

30-day notification letter to FDA, identification of the product =

ingredients, evidence to substantiate the claim, evidence to =

substantiate safety, assurances that GMPs were followed, and the =

qualifications of the persons who reviewed the data on safety and =

efficacy. FDA has stated that it agrees with the guidance of the =

commission and encourages DS manufacturers making SF claims to follow =

this guidance. Contrary studies should be considered when deciding =

whether to make and how to word a SF claim to assure that any statements

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made are truthful and not misleading. In a rule that affects the =

" phytoequivalence " issue of herbal products, FDA says that there is no =

 

specific statutory requirement that the studies substantiated in the =

statement be performed using the actual marketed formulation. However,

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many ingredients and factors influencing the formulation can affect the

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safety and effectiveness of the DS. These variations from the marketed

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product should be considered before using a study to substantiate a =

claim made for a particular product.=20

 

Structure/Function Claims for Conventional Foods. A large area of =

activity in the market has developed in the area of claims for =

conventional foods, where manufacturers have added herbs and other =

supplement ingredients to foods and then made SF claims for them. FDA =

has stated that this rule applies to claims for DS only. FDA advises, =

however, that for consistency, FDA is likely to interpret the dividing =

 

line between SF claims and disease claims in a similar manner for =

conventional foods as for DS.=20

 

Relationship Between Structure/Function Claims and Health Claims. =

Structure/function claims are not a subset of health claims as defined =

 

in NLEA. To be a health claim, a claim must refer to the relationship =

between a food substance and a disease or health-related condition. FDA

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interprets " health-related condition " to mean a state of health leading

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to disease. This rule makes clear that only SF claims that do not assert

 

health claims may be made.=

Implementation Plan. All manufacturers will have 11 months after the =

effective date of the final rule (February 7, 2000) to come into =

compliance. Small business will have 17 months after the effective date

=

of the final rule.

Loren Israelsen is president of LDI Group, a consulting firm =

specializing in the regulation and marketing of DS. He was heavily =

involved in the development and passage of DSHEA. Mark Blumenthal is =

editor of HerbalGram and executive director of ABC.=20

 

Table 1: Examples of Allowed Conditions and Statements for which

Structure/Function ClaimsCan Be Made under DSHEA

Abstentmindedness and mild memory problems associated with aging

Antispasmodic

Appetite suppressant and weight loss (if no link to obesity)

As part of diet to maintain healthy blood sugar levels

Leg edema associated with pregnancy

Treats/prevents nocturnal leg muscle cramps

Helps support cartilage and joint function

Promotion of digestion

Maintainence of cholesterol levels that are already within the normal

range

Hair loss associated with aging

Hot flashes

Immune system function

Maintenance of intestinal flora

Healthy lung function

Laxative (occasional constipation)

Minor muscle pain during exercise

Morning sickness associated with pregnancy (rescinded by FDA on Feb. 9,

2000)

Noncystic acne

Premenstrual syndrome (PMS) and normal, healthy attitude during PMS

Support for menopausal women

Presbyopia (inability to change focus from near to far, and vice versa,

associated

with aging)

 

Mild mood changes, cramps and edema associated with the menstrual cycle

 

Other signs of aging on the skin, e.g., liver spots, spider veins

 

Smoking alternative, reduced desire to smoke, mimics oral sensations of

=

cigarette smoke

 

Inceases stamina

 

Relief of stress and frustration

 

Tonic

 

Wrinkles

 

=20

 

Table 2: Examples of Conditions and Statements that Remain Disease =

Claims; Not Permitted under DSHEA

 

Alzheimer's disease and other senile dementia

Antibiotic

Antiinflammatory

Anticonvulsant

Arteriosclerotic diseases in coronary, cerebral or peripheral blood

vessels

Benign prostatic hyperplasia (BPH)

Promotes low blood pressure

Bronchodilator

Relieves crushing chest pain

Lowers cholesterol

Chronic constipation

Expectorant

Maintains well being during cold and flu season and dietary support

during cold

and flu season

Cystic acne

Decreases effect of alcohol intoxication

Controls blood sugar in persons with insufficient insulin

Glaucoma

Headache tension

Prevents irregular heart beat

Maintains healthy lungs in smokers

Nasal decongestion

Osteoporosis

Maintains normal bone density in post-menopausal women

Prohibits bone fragility in post-menopausal women

Inhibits platelet aggregation

yperemesis gravidarum of pregnancy

Acute psychosis of pregnancy

Toxemia of pregnancy

Severe depression associated with the menstrual cycle

Deters bacteria from adhering to the wall of the bladder and urinary

tract

Helps maintain normal urine flow in men over 50

 

Table 3: OTC Drug Monographs Containing Claims

Now Allowed as Structure/Function Claims under DSHEA

 

Antacid

Antigas

Anti-emetic (Nausea)

Aphrodisiacs

Daytime sedatives (stress, tension)

Digestive aid

Laxative

Nighttime Sleep-aid

Stimulant

Stool softener

Weight