FDA PROPOSES NEW HEALTH CLAIM RULES
Four years after the passage of the historic Dietary Supplement Act of
1994, in April 1998, the FDA has proposed rules on permissible health claims for dietary
supplements. Positive health support claims are "in" and disease claims are
"out." The FDA is struggling on this issue and has invited public comment. The
proposed rules start a "working dialogue." In a year or two the U.S. should have
permanent rules.
A HISTORIC ACT
It is officially called the Dietary Supplement Health and Education Act
of 1994 and it was signed into law in October, 1994. It has had profound impact on the
network marketing industry, an industry which is historically dominated by the sale of
nutritional and dietary supplements.
It was not necessarily an end to the war between the FDA and the health
food supplement industry, but it was a major victory for marketers of vitamins and dietary
supplements. At issue in the battle has always been whether or not the industry could
market its vitamins, amino acids, nutritional supplements, etc. and what could be said
about their products. From time to time, the industry has been labeled by the FDA as a
bunch of snake oil salesmen, and the industry has accused the FDA of inflexibility and
intolerance of its products and health messages. As late as the 1980s, the FDA was
accusing breakfast cereal manufacturers of peddling drugs because of health messages
regarding the relationship between fiber and cancer. Over the ensuing years, the FDA began
to recognize the role and relationship between diet and disease, but the love-hate
relationship between the FDA and health food industry continued to cycle every few years.
Prior to the 1994 legislation, relations between the FDA and the
dietary supplement industry reached a new low. The industry was genuinely concerned that
the FDA's new proposals might mean an end to a variety of dietary supplements on the
shelf, as well as the stifling of the communication of dietary supplement information to
the public. Senator Orrin Hatch and Congressman Bill Richardson ushered through Congress
the Dietary Supplement Health and Education Act of 1994 to protect the right of the
industry to distribute its products and disseminate information. Although it doesn't
accomplish everything the industry wanted, the industry breathed a major sigh of relief at
its passage. At its bare bones, the new legislation does the following:
Allows third party literature about dietary supplements to be
disseminated,
Allows labels on dietary
supplements to describe how supplements provide nutritional or dietary support for a
person,
Places the burden of proof that
a dietary supplement is unsafe on the FDA,
Provides that the dietary
supplements are not "food additives" and that the FDA may not arbitrarily remove
supplements from the marketplace by labeling them as unapproved "food
additives,"
The Act provided for a
presidential commission of unbiased experts in dietary supplements during the next two
years to provide recommendations and established procedures for evaluating health claim
label statements. After that the FDA was to issue proposed rules and invite public
comment.
THE PRESIDENT SPEAKS
There can be no mistake that this legislation is intended to limit what
the industry has felt has been intrusive regulation by the FDA. In signing the legislation
into law, President Clinton issued a statement which summarized the frustrating
relationship:
"After several years of intense efforts, manufacturers, experts in
nutrition, and legislators, acting in a conscientious alliance with consumers at the
grassroots level, have moved successfully to bring common sense to the treatment of
dietary supplements under regulation and law.
"More often than not, the Government has been their ally. And the
private market has responded to this development with the manufacture of an increasing
variety of safe supplements.
"But in recent years, the regulatory scheme designed to promote
the interests of consumers and a healthful supply of good food has been used instead to
complicate choices consumers have made to advance their nutritional and dietary goals.
With perhaps the best of intentions agencies of government charged with protecting the
food supply and the rights of consumers have paradoxically limited the information to make
healthful choices in an area that means a great deal to over 100 million people."
AND CONGRESS SPEAKS OUT
And, Congress itself made it very clear that the role of dietary
supplements was to play an important role in our health care system and the dissemination
of information. In its preamble to the Act, Congress made the following findings:
"(1) improving the health status of United States citizens ranks
at the top of the national priorities of the Federal Government;
"(2) the importance of nutrition and the benefits of dietary
supplements to health promotion and disease prevention have been documented increasingly
in scientific studies;
"(3)(A) there is a link between the ingestion of certain nutrients
or dietary supplements and the prevention of chronic diseases such as cancer, heart
disease, and osteoporosis; and
"(B) clinical research has shown that several chronic diseases can
be prevented simply with a healthful diet, such as a diet that is low in fat, saturated
fat, cholesterol, and sodium, with a high proportion of plant-based foods;
"(4) healthful diets may mitigate the need for expensive medical
procedures, such as coronary bypass surgery or angioplasty;
(5) preventive health measures, including education, good nutrition,
and appropriate use of safe nutritional supplements will limit the incidence of chronic
diseases, and reduce long-term health care expenditures;
"(6)(A) promotion of good health and healthy lifestyles improves
and extends lives while reducing health care expenditures; and
"(B) reduction in health care expenditures is of paramount
importance to the future of the country and the economic well-being of the country;
"(7) there is a growing need for emphasis on the dissemination of
information linking nutrition and long-term good health;
"(8) consumers should be empowered to make choices about
preventive health care programs based on data form scientific studies of health benefits
related to particular dietary supplements;
"(9) national surveys have revealed that almost 50 percent of the
260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or
herbs as a means of improving their nutrition;
"(10) studies indicate that consumers are placing increased
reliance on the use of nontraditional health care providers to avoid the excessive costs
of traditional medical services and to obtain more holistic consideration of their needs;
"(11) the United States will spend over $1,000,000,000,000 on
health care in 1994, which is about 12 percent of the Gross National Product of the United
States, and this amount and percentage will continue to increase unless significant
efforts are undertaken to reverse the increase;
"(12)(A) the nutritional supplement industry is an integral part
of the economy of the United States;
"(B) the industry consistently projects a positive trade balance;
and
"(C) the estimated 600 dietary supplement manufacturers in the
United States produce approximately 4,000 products, with total annual sales of such
products alone reaching at least $4,000,000,000;
"(13) although the Federal Government should take swift action
against products that are unsafe or adulterated, the Federal Government should not take
any actions to impose unreasonable regulatory barriers limiting or slowing the flow of
safe products and accurate information to consumers;
"(14) dietary supplements are safe within a broad range of intake,
and safety problems with the supplements are relatively rare; and
"(15)(A) legislative action that protects the right of access of
consumers to safe dietary supplements is necessary in order to promote wellness; and
"(B) a rational Federal framework must be established to supersede
the current ad hoc, patchwork regulatory policy on dietary supplements."
IMPACT ON NETWORK MARKETING INDUSTRY
Can network marketers of dietary supplements sleep better after this
legislation? The answer is an absolutely qualified "Yes." Keep in mind, however,
that the new legislation is not intended to open the floodgates to unsubstantiated health
claims. On the other hand, the new legislation will be helpful in many ways to marketers
of nutritional supplements.
THIRD PARTY LITERATURE
The most significant tool to network marketers to come from the
legislation is its pronouncement on third party literature. Prior to the new legislation,
passing out third party literature about a dietary supplement constituted
"labeling," rendering the dietary supplement to the classification of a drug by
the FDA. The new act provides as follows:
"DIETARY SUPPLEMENT LABELING EXEMPTIONS
"SEC. 403B.(a) IN GENERAL.--A publication, including an article, a
chapter in a book or an official abstract of a peer-reviewed scientific publication that
appears in an article and was prepared by the author or the editors of the publication,
which is reprinted in its entirety, shall not be defined as labeling when used in
connection with the sale of a dietary supplement to consumers when it--
"(1) is not false or misleading;
"(2) does not promote a particular manufacturer or brand of a
dietary supplement;
"(3) is displayed or presented, or is displayed or presented with
other such items on the same subject matter, so as to present a balanced view of the
available scientific information on a dietary supplement;
"(4) if displayed in an establishment, is physically separate from
the dietary supplements; and
"(5) does not have appended to it any information by sticker or
any other method.
"(b) APPLICATION.--Subsection (a) shall not apply to or restrict a
retailer or wholesaler of dietary supplements in any way whatsoever in the sale of books
or other publications as a part of the business of such retailer or wholesaler.
"(C) BURDEN OF PROOF.--In any proceeding brought under subsection
(a), the burden of proof shall be on the United States to establish that an article or
other such matter is false or misleading."
What does all this mean? Because of the breadth of this section, there
may be a long period before the health industry and FDA agree about what legislation
means. But at face value, it would suggest that network marketers may pass out third party
articles or books on dietary supplements in conjunction with the sale of their products if
the information is not false and misleading and does not promote a particular brand of
product. Inasmuch as there is a wealth of scientific literature, articles and books on
dietary supplements, this may mean the free flow of information for the first time.
CERTAIN NUTRITIONAL HEALTH CLAIMS CAN BE MADE
The new Act provides that a statement for a dietary supplement may be
made if
"(A) the statement claims a benefit related to a classical
nutrient deficiency disease and discloses the prevalence of such diseases in the United
States, describes the role of a nutrient or dietary ingredient intended to affect the
structure or function in humans, characterizes the documented mechanism by which a
nutrient or dietary ingredient acts to maintain such structure or function, or describes
general well-being from consumption of a nutrient or dietary ingredient.
"(B) the manufacturer of the dietary supplement has substantiation
that such statement is truthful and not misleading, and
"(C) the statement contains, prominently displayed and in boldface
type, the following: 'this statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat, cure or prevent any
disease.'"
Four years after the legislation and in the aftermath of the
recommendations of a Presidential commission, the FDA in April 1998 issued proposed rules
on permissible "structure/function" claims versus prohibited "disease"
claims. Permanent rules will follow after a public comment period.
It is clear the FDA is struggling with this issue. The FDA appears to
embrace general health claims that support healthy body function, but wishes to prohibit
"disease" claims in which a dietary supplement is to be used to treat a disease
or medical condition.
Here is how the FDA attempted to
draw the line on the "semantics" of claims:
Bold = Prohibited Disease Claim
Italics = Permissible structure/function health claim
Under proposed rules, a statement would be considered a claim if
it explicitly or implicitly claimed an effect on a specific disease or class of diseases.
Examples of such disease claims include: "protective against the development of
cancer," "reduces the pain and stiffness associated with arthritis,"
"decreases the effects of alcohol intoxication," or "alleviates
constipation." Claims that do not refer explicitly or implicitly to an effect on a
specific disease state would not be disease claims under this criterion. Examples include:
"helps promote urinary tract health," "helps maintain cardiovascular
function and a healthy circulatory system," and "promotes relaxation."
FDA has tentatively concluded that these examples do not contain express or implied
references to specific diseases. Instead, they refer broadly to body systems or functions
without sufficient reference to specific abnormalities or symptoms to be understood as
references to particular diseases.
The proposed rules define
disease as any one of several types of abnormalities that are "manifested by a
characteristic set of one or more signs or symptoms." FDA believes that reference to
a characteristic set of signs or symptoms, even in the absence of the name of the disease,
can be understood as a reference to the disease itself. Under proposed rules, a
statement would be considered a disease claim if it explicitly or implicitly claimed an
effect (using scientific or lay terminology) on one or more signs or symptoms that are
recognizable to health care professionals or consumers as being characteristic of a
specific disease or of a number of diseases. Examples of such disease claims include:
"improves urine flow in men over 50 years old" (characteristic symptoms of,
e.g., benign prostatic hypertrophy); "lowers cholesterol" (characteristic sign
of, e.g., hypercholesterolemia); "reduces joint pain" (characteristic symptom
of, e.g., arthritis); and "relieves headache" (characteristic symptom of, e.g.,
migraine or tension headache). In each of these cases, the symptoms described are
sufficient to characterize one or more specific diseases.
Claims of an effect on symptoms that are not recognizable as characteristic of a specific
disease or diseases would not constitute disease claims. Examples include: "reduces
stress and frustration," "inhibits platelet aggregation," and
"improves absentmindedness." In these examples, the signs or symptoms noted
may be broadly associated with a number of diseases, but are not, by themselves,
sufficient to characterize a specific disease or diseases. If the context did not suggest
treatment or prevention of a disease, a claim that a substance helps maintain normal
function would not ordinarily be a disease claim. Examples include: "helps
maintain a healthy cholesterol level," or "helps maintain regularity."
Certain natural states, such as
pregnancy, aging, or the menstrual cycle, that are themselves not "diseases,"
are sometimes associated with abnormalities that are characterized by specific set of
signs or symptoms, and thus meet the proposed definition of disease.
Under proposed rules, a statement would be considered a disease claim if it explicitly
or implicitly claimed an effect on a consequence of a natural state that presents a
characteristic set of signs or symptoms recognizable to health care professionals or
consumers as constituting an abnormality of the body, such as toxemia of pregnancy,
premenstrual syndrome, or abnormalities associated with aging such as presbyopia,
decreased sexual function, Alzheimer's disease, or hot flashes. Claims that did not refer
to a recognizable abnormality resulting from a natural state or to it signs or symptoms
(e.g., "for men over 50 years old," and "to meet nutritional needs
during pregnancy") would not be disease claims under this criterion. These
examples do not include references to specific abnormalities or symptoms. FDA thus
believes that they would not be understood as references to particular diseases.
Various aspects of a product's
labeling may be used to express or imply that the product will diagnose, cure, mitigate,
treat, or prevent disease. Under proposed rule, a statement would be considered a
disease claim if it explicitly or implicitly claimed an effect on disease through one or
more of the following factors:
The name of the product (e.g., "Carpaltum" (carpal
tunnel syndrome), "Raynaudin" (Raynaud's phenomenon), "Hepature"
(liver problems)). Names that did not imply an effect on a disease, such as
"Cardiohealth" and "Heart Tabs," would not constitute disease claims;
Statements about the formulation of the product, including a claim
that the product, including a claim that the product contained an ingredient that has been
regulated primarily by FDA as a drug and is well known to consumers for its use in
preventing or treating a disease (e.g., aspirin, digoxin, or laetrile)
Citation of a title of a publication or other reference, if the
title refers to a disease use. For example, labeling for a vitamin E product that
included a citation to an article entitled "Serial Coronary Angiographic Evidence
That Antioxidant Vitamin Intake Reduces Progression of Coronary Artery
Atherosclerosis," would create a disease claim under this criterion;
Use of the term "disease" or "diseased;"
or
Otherwise suggesting an effect on disease by use of pictures,
vignettes, symbols, or other means (e.g., electrocardiogram tracings, pictures of
organs that suggest prevention or treatment of a disease state, the prescription symbol
(Rx), or any reference to prescription use). A picture of a body would not constitute a
disease claim under this criterion.
Certain product class names are so strongly associated with
diagnosis, cure, mitigation, treatment or prevention of a disease or diseases, that a
claim that a product belonged to such a class would be understood as a disease claim.
Under proposed rules, a statement would be considered a disease claim if it claimed that
the product belonged in a class of products recognizable to health care professionals or
consumers as intended for use to diagnose, mitigate, treat, cure, or prevent a disease
(e.g., claims that the product was an "antibiotic," a "laxative," an
"analgesic," an "antiviral," a "diuretic," an
"antimicrobial," an "antiseptic," an "antidepressant," or a
"vaccine"). The foregoing examples do not constitute an exclusive list of
product class names that convey disease claims. Claiming that a product was in a class
that is not recognizable to health care professionals or consumers as intended for use of
diagnose (e.g., an "energizer," a "rejuvenative," a
"revitalizer," or an "adaptogen") would not constitute a disease claim
under this criterion.
A statement may imply that a dietary supplement has an effect on
disease by claiming that the effect of the dietary supplement is the same as that of a
recognized drug or disease therapy. A statement may also imply an effect on disease by
suggesting that the dietary supplement should be used as an adjunct to a recognized drug
or disease therapy in the treatment of a disease. In both cases, the statement implies
that the dietary supplement is intended for the same purpose as the drug or disease
therapy, i.e., for the diagnosis, cure, mitigation, treatment, or prevention of disease.
Under proposed rules, a statement would be considered a disease claim if it explicitly
or implicitly claimed that the product was a substitute for another product that is a
therapy for a disease (e.g., "Herbal Prozac") or that it augmented a
particular therapy or drug action (e.g., "use as part of your diet when taking
insulin to help maintain a healthy blood sugar level"). A claim that did not identify
a specific drug, drug action, or therapy (e.g., "use as a part of your weight loss
plan") would not constitute a disease claim under this criterion.
A statement may contain an express or implied disease claim if it
suggest that the product cures, mitigates, treats or prevents a disease or diseases by
augmenting the body's own disease-fighting capabilities. Under proposed rules, a
statement would be considered a disease claim if it explicitly or implicitly claimed a
role in the body's response to a disease or to be a vector of disease. A vector of
disease is an organism or object that is able to transport or transmit to humans an agent,
such as a virus or bacterium, that is capable of causing disease in man. A claim that a
product "supports the body's antiviral capabilities" or "supports the
body's ability to resist infection" would constitute a disease claim under this
criterion. Infections are well-known disease states that result from the action of
pathogenic (disease-causing) microorganisms, such as bacteria and viruses, and are
deviations from and impairments of the normal structure and/or function of the body with
characteristic signs and symptoms. Claims that a product is intended to affect the body's
ability to kill or neutralize pathogenic microorganisms, or to mitigate the consequences
of the action of pathogenic microorganisms on the body (i.e., the signs and symptoms of
infection) are disease claims because they are claims exclusively associated with the
body's ability to prevent or respond to infectious diseases. A more general reference
to an effect on a body system that has several functions, only one of which is resistance
to disease, would not constitute a disease claim under this criterion (e.g.,
"supports the immune system").
Claims that a product is intended to counter adverse events resulting from medical
intervention are claims that the product is intended as a part of the treatment program
and, as such, are claims that the product is to mitigate, treat, or cure the disease
state. Under proposed rules, a statement would be considered a disease claim if it
explicitly or implicitly claimed to treat, prevent, or mitigate adverse events associated
with a medical therapy or procedure and manifested by a characteristic set of signs or
symptoms (e.g., "reduces nausea associated with chemotherapy," "helps
avoid diarrhea associated with antibiotic use," and "to aid patients with
reduced or compromised immune function, such as patients undergoing chemotherapy"). A
claim that did not mention a therapy for disease (e.g., "helps maintain healthy
intestinal flora") would not constitute a disease claim under this criterion.
As can be seen, defining "prohibited disease claim" vs
permissible "health support claim" is a gray area. It is one that the FDA, Heath
Industry and the public will probably be debating a decade from now, even after the FDA
adopts permanent rules to the Dietary Supplement Health and Education Act. The proposed
rules, after public comment, may not see the light of day, but they start a "working
dialogue."
CONCLUSION
The Dietary Supplement Health and Education Act should have a profound
impact on the network marketing industry in the positive. It assures future availability
of dietary supplements and dissemination of information, and establishes a framework for
fitting dietary supplements into the future of our health care system. It is certainly not
the end of the issue, it is merely one step in a very positive process for the American
consumer.
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