FDA rules continued

[Guest guest]

make that 3 parts

 

unless the labeling made clear the product was intended only for =

occasional sleeplessness. HepataCare and HepataHealth could also be =

considered disease claims because " Hepata " could be read as a reference

=

to hepatitis unless the labeling made clear that the product was =

intended for general liver health and not intended to treat or prevent =

 

hepatitis. FDA will issue for public comment a draft guidance to provide

=

clarification and examples of claims and product names that would and =

would not be considered disease claims under the final rule.=20

 

Product Formulation. Listing a dietary ingredient in the ingredient list

=

of a DS will not be considered to imply an effect on disease unless the

=

ingredient is one that has been regulated primarily as a drug and is =

well-known to consumers for its use or claimed use in preventing and =

treating a disease. In those cases where a manufacturer does add a drug

=

ingredient to its product that is well-known to treat or prevent disease

=

and label its presence, FDA may consider it a disease claim. This also =

 

pertains to a dietary ingredient found in common foods whose biological

=

activity is first characterized in a food context but which is =

subsequently approved as a drug, i.e., indol-3-carbinol (I3C), a =

compound discovered in broccoli and other vegetables. The question =

arises: If I3C were to be approved as a breast cancer drug, would a =

claim that a vegetable-based DS product contains I3C be permitted as a =

 

structure/function claim? Where an ingredient has been approved as a =

drug, DSHEA prohibits marketing of the ingredient as a DS, unless the =

ingredient itself was previously marketed as a food (including a DS), or

=

unless a food containing the ingredient was previously marketed for the

=

presence of the ingredient. In this example, the isolated ingredient I3C

=

could not be marketed as a DS unless a food containing I3C had been =

marketed for the presence of I3C before the drug was approved or was the

=

subject of substantial investigations that had been made public. For =

purposes of this section, the agency may consider as a disease claim a =

 

claim that the product contains an ingredient that has been regulated by

=

FDA as a drug, whether marketed OTC or by prescription, and that is well

=

known for its use in preventing or treating disease. This is the =

so-called Cholestin=AE " provision " referring to the case of a product =

composed of Chinese red yeast rice that contains a naturally-occurring =

 

compound that has also been approved as a drug, i.e., lovastatin, for =

the reduction of cholesterol levels.=20

 

Citation of Publication Titles. FDA agrees that in enacting DSHEA, =

Congress intended to encourage the dissemination of scientific research

=

and truthful, non-misleading information. FDA also agrees that =

consumers can benefit from reviewing the scientific support used to =

substantiate a statement for a DS. In keeping with these goals, FDA has

=

modified the law to narrow the circumstances under which citation to a =

 

scientific reference will be deemed a disease claim. Citation of a title

=

referring to a disease will be treated as a disease claim if, in the =

context of the labeling as a whole, the citation implies treatment or =

prevention of a disease. One element that the agency will look at is the

=

prominence of the citation in the labeling. If, for example, the =

citation is simply listed in the bibliography section of the labeling =

among other titles, it generally will not suggest an implied disease =

claim. On the other hand, highlighting, bolding, using large type size =

 

or prominent placement of the citation that refers to a disease use in =

 

the title could suggest the product has an effect on disease. The agency

=

will also consider whether the cited article provides legitimate support

=

for an SF claim that appears in the labeling of the DS. Enhancing the =

bibliography with citations to scientific references that refer to a =

disease in the title that have no reasonable relation to the SF claim =

will be considered a disease claim. FDA will also consider whether =

citations are to bona fide research. FDA encourages manufacturers to =

cite references that provide a balanced discussion of the evidence =

supporting a SF claim. If specific information about an unlabeled use of

=

a product is requested by a consumer and the request is not solicited by

=

the manufacturer, providing articles that are responsive to the request

=

will not be considered a disease claim.=20

 

In an interesting development affecting supplement manufacturers who =

fund scientific research on their own products, FDA states that third =

party literature provisions of DSHEA do not apply to the citation of =

titles in product labeling, because the third-party literature exemption

=

applies when only when the publication does not promote a particular =

manufacturer or brand of DS. Therefore, if the reference or the title =

 

of the reference was disseminated by a manufacturer of the DS discussed

=

in the reference, FDA concludes that this use promotes the =

manufacturer's brand, and that the third party literature exemption =

would not apply. Further, such publications must be displayed or =

presented with other such items to present a balanced view of the =

available scientific information. A citation to an article alone could

=

not meet these requirements.=20

 

Use of " Disease " or " Diseased. " The terms " disease " or " diseased " =

classify a statement as a disease claim. FDA agrees that general =

statements about health promotion and disease prevention may be =

acceptable as long as the statements do not imply that a specific =

product can diagnose, mitigate, cure, treat or prevent disease.=20

 

Pictures, Vignettes, and Symbols. FDA agrees that in most cases a =

picture of a healthy organ would not be considered a disease claim if =

the labeling as a whole does not imply treatment or prevention of =

disease. The heart symbol, however, is widely recognized for disease =

treatment/prevention, and its use constitutes an implied disease claim.

=

A picture of a healthy EKG tracing is also an implied disease claim. =

Also, the heart symbol has become so widely associated with the =

prevention of heart disease that its use in the labeling of DS would =

ordinarily be considered an implied heart disease prevention claim.=20

 

Membership in Product Class. Previously, the proposed rule provided =

examples of " class names " that would imply disease, treatment or =

prevention and were not allowed. These included the terms antibiotic, =

 

laxative, analgesic, antiviral, diuretic, antimicrobial, antiseptic, =

antidepressant, and vaccine, among others. Acceptable examples included

=

energizer, rejuvenative, revitalizer or adaptogen. Now FDA has decided =

 

that claims for relief of occasional constipation are not disease =

claims; thus, the term " laxative " is not considered a disease claim. The

=

claim " appetite suppressant " is an acceptable SF claim because obesity =

 

is a disease, not overweight. An appetite suppressant may be intended =

 

for ordinary weight loss, rather than a treatment for obesity. =

Therefore, such a claim may be appropriate in context. The claim " tonic "

=

is not a disease claim. FDA does not consider the term " antispasmodic " =

 

to constitute a disease claim because it is not closely associated with

=

treatment or prevention of gastrointestinal disease. The term =

" anti-inflammatory " is a disease claim because it is strongly associated

=

with treatment of certain serious gastrointestinal diseases. However, a

=

term considered a substitute for disease therapy would be a disease =

claim if it explicitly/implicitly claimed that a DS was a substitute for

=

another product that is a therapy for disease. " Herbal Prozac " and " Herb

=

Phen-fen " are examples.=20

 

Augmentation of Therapy or Drug for Disease. FDA agrees that DS may be

=

useful in providing nutritional support. Associating such statements =

with an express or implied claim that a DS augments therapy or drug =

action, however, implies the DS has a role in treating or preventing the

=

disease for which the drug or therapy is used. Example: " Use as part of

=

your diet when taking insulin to help maintain a healthy blood sugar =

level " is a disease claim. However, " Use as part of your diet to help =

 

maintain a healthy blood sugar level " is acceptable. Deleting the =

reference to insulin removes the implication that the DS is augmenting =

 

the insulin to treat, mitigate, prevent, or cure diabetes. The terms =

" strengthen, reduce, improve, modify, inhibit, protect " or " defend " may

=

be appropriate terms in some contexts, i.e., when the statements do not

=

suggest disease prevention or treatment use. If however, these terms =

imply that the DS augments a particular therapy or drug action or =

suggests an effect on disease, FDA will consider these statements =

disease claims.=20

 

Role in Body's Response to Disease or Disease Vector. Under the final =

 

proposed regulation, the statements " supports the body's antiviral =

capabilities " or " supports the body's ability to resist infection " are =

 

disease claims. However, " supports the immune system " is acceptable. A =

 

claim that a product supports the body's antiviral capabilities =

represents a claim of treatment or prevention of a specific class of =

diseases, those caused by viruses (e.g., colds, hepatitis, or HIV =

infection) and is therefore not allowed for a DS.=20

 

Treatment/Prevention of Adverse Events. Because this final rule uses a

=

different definition of disease than FDA had proposed in its earlier =

ruling in 1998, this section has been revised to state that claims about

=

adverse events are disease claims only " if the adverse event constitutes

=

disease. " =20

 

Claims that a product is useful because it counterbalances the effect of

=

a drug in depleting a nutrient or interfering with the metabolism of a =

 

nutrient are acceptable SF statements. However, if a claim expressly or

=

implicitly suggests that a DS is intended to augment a specific drug, =

drug action, or therapy for a disease or serve the same purpose as a =

specific drug or therapy for a disease, then the statement may be =

considered a disease claim. Example: " Helps individuals using =

antibiotics to maintain normal intestinal flora " is a disease claim, but

=

" Helps maintain intestinal flora " is acceptable. Rationale: The =

statement " helps individuals using antibiotics to maintain normal =

intestinal flora " does not explicitly refer to a disease, but there is =

 

an implicit claim that use of a DS while taking antibiotics will prevent

=

or mitigate a disease. Why? Persons using certain antibiotics are at =

 

risk of developing overgrowth in the gut of a pathogenic organism, =

because along with fighting the target organism in the body, the =

antibiotic can suppress normal intestinal flora that are used to prevent

=

infection in the gastrointestinal tract. Thus, in FDA's view, this =

statement would make an implied disease prevention claim.=20

 

Otherwise Affects Disease. Under the final rule, a statement would be a

=

disease claim if it suggests an effect on a disease or class of diseases

=

in a manner other than those specifically set out in the first nine =

criteria mentioned above. This is the " catch-all " provision. In the =

comments, FDA was asked to comment on the following statements: =

" Provides nutritional support for women during premenstruation by =

promoting proper fluid balances and breast health. " " Ginger supports the

=

cardiovascular system by inhibiting leukotriene and thromboxane =

synthesis, substances associated with platelet aggregation. " These do =

 

not appear to FDA to constitute drug claims.=20