FDA Proposes New Health Claim Rules
By Jeffrey A. Babener
Excerpted from Network Marketing: What You Should
Know, Jeffrey Babener, Legaline Publications
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The Impact on the 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.
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 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 therecommendations 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 claim 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 ifit explicitly or implicitly claimed an effect on a specific disease orclass 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. Example of such disease claims include: "improves urine flow in men over 50 years old" (characterized 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 sign 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 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 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:
(a) 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;
(b) 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)
(c) 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;
(d) Use of the term "disease" or "diseased;" or
(e) 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," am "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 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 as 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. Infectious 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 mitigate the consequences of the action of pathogenic microorganisms on the body (e.g., 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, Health 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.
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