"... 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."

FDA Health Claims:
The Final Rules

By Jeffrey A. Babener

2000

 

GOOD NEWS FOR NETWORKERS

At the turn of the millennium, six years after passage of the historic Dietary Supplement Act of 1994, the FDA issued its final rules. And they are good news for networkers – Networkers can "get the word out" on their products. (1) 3rd party literature can be passed out; (2) positive health support claims are permissible (but disease claims are "out"); (3) in its final rules, the FDA expanded its horizon even further to allow health support claims associated with normal stages of life such as "hot flashes" and menopause, memory problems of aging, PMS and menstrual cycles – even "hair loss"!

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:

  1. Allows third party literature about dietary supplements to be disseminated,

  2. Allows labels on dietary supplements to describe how supplements provide nutritional or dietary support for a person,

  3. Places the burden of proof that a dietary supplement is unsafe on the FDA.

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."

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 is 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.

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 promotes the free flow of information.

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.'"

STRUCTURE/FUNCTION – YES; DISEASE CLAIM – NO

The point of the legislation is to allow companies that sell dietary supplements to promote positive health support claims for structure and function of the body. On the other hand, the legislation is still intended to prohibit the making of health claims with respect to dietary supplements and specific diseases. Although this legislation is very helpful to networkers, it may be necessary to have an FDA legal specialist available to really figure out what can be said.

Here are some examples of some express disease claims that cannot be made:

Protects against development of cancer

Reduces pain and stiffness associated with arthritis

Decreases the effects of alcohol intoxication

Alleviates constipation

Examples of implied disease claims include:

Relief of sneezing, runny nose, and itchy watery eyes caused by exposure to pollen or other allergens

Relieves crushing chest pain

Prevents bone fragility in post-menopausal women

Improves joint mobility and reduces joint inflammation and pain

Heals stomach or duodenal lesions and bleeding

Prevents wasting in persons with weakened immune systems

Prevents irregular heart beat

Controls blood sugar in persons with insufficient insulin

On the other hand, examples of permissible structure/function claims include:

Helps promote urinary tract health

Helps maintain cardiovascular function and a healthy circulatory system

Helps maintain intestinal flora

Promotes relaxation

For relief of occasional constipation [provided the product label and labeling makes clear that the product is not intended to be used to treat chronic constipation]

SIGNS OR SYMPTOMS OF DISEASE

Examples of impermissible disease claims include:

Improves urine flow in men over 50 years old

Lowers cholesterol

Reduces joint pain

Relieves headache

Inhibits platelet aggregation

Maintaining a tumor-free state

Maintain normal bone density in post-menopausal women

Restore normal blood pressure

Maintain healthy lungs in smokers

Lowers cholesterol

Promotes cholesterol clearance

On the other hand, examples of permissible structure/function claims include:

Reduces stress and frustration

Improves absentmindedness

Helps maintain regularity

Helps support cartilage and joint function

Maintains healthy lung function

Helps to maintain cholesterol levels that are already within the normal range

STAGES OF LIFE

In the final FDA rules, the FDA further expanded the types of claims that could be made with respect to dietary supplements to things that were formerly thought of as disease claims. The FDA recognized that dietary supplements may be helpful for common medical problems that are associated, not with disease, but with stages of life of everyone. For instance, the FDA adopted a position that the claims "support a normal, healthy attitude during PMS" and "support for menopausal women" are appropriate structure/function claims. Claims about diminishing the normal symptoms of premenstrual syndrome or menopause would also be acceptable structure/function claims. In fact, if marketers of dietary supplements can support their claims, they are entitled to make structure function support claims about the following stage of life problems:

Morning sickness associated with pregnancy

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

Hot flashes

Wrinkles

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

Mild memory problems associated with aging

Hair loss associated with aging

EVERY DAY ACHES AND PAINS

The FDA has even gone to some effort to allow health claims to be made for dietary supplements that support every day types of problems as opposed to diseases. Examples of the sorts of claims that can be made regarding these problems would include:

  1. Intended to treat and provide minor pain relief

  2. Boosts stamina or helps enhance muscle tone

  3. Provides dietary support during the cold and flu season

  4. Temporarily reduces your desire to smoke

  5. Provides relief from an upset stomach

  6. Helps prevent motion sickness

  7. Provides relief from occasional sleeplessness

  8. Helps provide relief from stress, such as (a) occasional simple tension, (b) nervousness due to common overwork and fatigue, (c) gently soothes away tension, (4) calming down and relaxing, (5) helps you relax, (6) arouses or increases sexual desire and improves sexual performance.

IMAGE NAMES ARE OKAY

Even some names that suggest a medical function, but are more in the image category have been given the green light by the FDA. Under the FDA's final rules, the following names are viewed as permissible and as not implying disease treatment:

Energizer
Rejuvenative
Revitalizer
Adaptogen
Appetite suppressant
Antispasmodic
Tonic

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.

 

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.

www.mlmlegal.com

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