"...the Dietary Supplement Health and Education Act of 1994... 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."
The FDA And Health Claims
By Jeffrey A. Babener
© July, 1998
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 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:
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:
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:
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
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
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.
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.
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:
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").
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."
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.
|Jeffrey A. Babener
Babener & Associates
121 SW Morrison, Suite 1020
Portland, OR 97204
|Jeffrey A. Babener, the principal attorney in the
Portland, Oregon law firm of Babener & Associates, represents many of the leading
direct selling companies in the United States and abroad.
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