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The United States Food and Drug Adminstration announced on April 27^th, 1998 in today's notice, their probable guidance and recommendations on dietary supplements. "The wheels of Justice turn Slowly but Finely".¹

In 1988 your editor wrote at the behest of then Deputy Director for USFDA that "Big Business (multi-million or billion dollar companies) is not in the business of being the F.D.A., and should not be promoted as such, or expected to be able to perform tasks which are not in their expertise, and are compromised by the intent to maximize profits, not the prophylactic maintenance or restoration of the health of great nations or their citizenship (such as the Food and Drug Administration).

Is there sufficient scientific data and information to allow the use of pseudo-scientific liberalized health information on dietary supplements or breakfast cereals and the like?  Obviously controversy exists because the "scientific" "truth" on vitamins, minerals, grains and so forth is still forthcoming.  The biological definition of a "vitamin" used to be that "it was a specifically necessary nutritional source needed by the body in small quantity". Once the F.D.A. was removed as the valid regulatory body involved in regulating prophylactic medically necessary nutritional supplementation, the definition was changed to a "food source needed by the body in a small quantity." Even though the Food and Drug administration has the word "food" in its name, it was still removed as a regulatory agency with any potency in relation to vitamin and mineral supplements.  Thus the development of today's food faddist and supplement quackery industry.

Individuals today advocate massive dosages of vitamins and minerals even though they know the body may not need the supplement. However the question must be asked, "What is the body doing with the rest of the unused supplement?" Common sense, deductive, inductive reasoning, as well as logic, would dictate that since the massive dosage is beyond what the body may need, the substance may become a drug with side effects, possible manifestations, and as yet other un-regulated and unpredictable reactions. Obviously this does not negate quality research, which has been demonstrating that a perhaps revised R.D.A. may be the answer. However studies have been indicating that the revised R.D.A. is on average approximately only 10-30% higher on "some" vitamins. Not 50-500,000% higher! The jury is not in yet on the "true" revised R.D.A. Thus this point is pre-reality and still moot. However the Food and Drug Administration is not allowed today to regulate these nutrients labeling claims effectively.

Now are we to believe that there is sufficient scientific data and information to allow the use of health information on dietary supplements, foods, topical-tonics such as hair shampoos, drinks, cereals, fast foods, and so forth in a new liberal way. Pre-reality. If we cannot control the fraud and mislabeling today, how will we protect the innocent with new liberalized labeling laws? Obviously again Big Business will come into a windfall. However was our country founded on this premise: Make Big Business rich first and serve the people second. Wrong! It was to make our nation free to think, healthy enough for quality contemplation's, have our own opinions, allow freedom of trade and the free market system, democracy, and a nation built on truth, justice and American idealism.... Thus to describe the role of an ingredient in terms of a sound dietary pattern, would be to allow a multiple and massive litany of non-scientific, non-validated cure claims or degree of curing claims, tied to known researched science. This equates to a license to commit hucksterism.

We must limit explanations to known scientific criteria of safety, reproducibility, reliability, passage of double-blinded studies, and efficacy, and not un-proven scientific theories, to which this opens the door.^1"

Today April 27th, 1998 the F.D.A. concurred with my suggestions and the Commission's suggestions. The FDA's responses are summarized below:

• The FDA should work with others to improve postmarket surveillance of dietary supplements. The FDA collects reports on serious adverse events associated with dietary supplements through two monitoring systems, but agrees that greater cooperation would be helpful. The agency presented this issue to its Food Advisory Committee (FAC) of outside experts. FAC has appointed a working group whose findings will be discussed at a later meeting.
  
• Manufacturers should include appropriate warning statements in their product information. The FDA intends to work with the Food and Advisory Committee and industry to develop guidance on the use of warning statements in dietary supplement labeling.
  
• The FDA should use its enforcement authority under DSHEA to swiftly resolve potential safety issues. FDA is committed to expediently removing unsafe products from the market, or to take other timely actions to protect consumers.
  
• The FDA should ensure that there is broad input to ascertain the degree of scientific agreement for a health claim. The FDA has considered and will continue considering the opinion of outside scientific experts in determining whether there is significant scientific conformity supporting the validity of health claims for foods and dietary supplements. This standard of significant scientific agreement is not affected by the FDA Modernization Act of 1997, which has provisions affecting health claims. The agency is open to suggestions from interested parties on how to improve its current approval process.
  
• Manufacturers should include in their notification letters for statements of nutritional support such additional information as a copy of the product label or the label mockup, and affirm that they can substantiate (i.e., the truthfulness, scientific validity, and nonmisleading nature of) their labeling claims. The FDA agrees, and will consider new rulemaking on this subject if experience warrants.
  
• Manufacturers' substantiation for statements of nutritional support should include such information as identification of the product's ingredients, evidence of safety, assurances that good manufacturing practices were followed, and the qualification of the person(s) who reviewed the data on safety and efficacy. The agency agrees with this guidance.
  
• The FDA should monitor the use of publications used in connection with the sale of dietary supplements. The agency intends to monitor the use of "third-party" publications to promote the sale of dietary supplements and, if necessary, will develop appropriate regulatory guidance to ensure that the information is balanced and truthful.
  
• A study is needed on the establishment of an alternative system for regulating botanicals with medical uses, and FDA should "promptly establish a review panel" for over-the-counter (OTC) claims made for such products. When there is sufficient support, FDA should consider the feasibility of approving botanicals for OTC uses. FDA has examined the regulatory status of botanicals with possible OTC uses for years, and has participated in conferences and symposia dealing with characterization of, and the safety and effectiveness of, botanical products for the past five years. The agency agrees that a much more comprehensive evaluation of a possible alternative system would be helpful. FDA personnel are available to cooperate with outside researchers on such matters, but FDA lacks the resources to initiate the comprehensive evaluation suggested by the Commission. FDA is in the process of proposing criteria for eligibility in the OTC drug review system that may allow the consideration of certain botanicals. The convening of a review panel,as suggested by the Commission, would be premature until such criteria have been finalized.
  
• A study should be conducted to determine whether consumers want and can use the available dietary supplement information to select helpful products. FDA agrees, and has asked FAC to consider how to best gather data on how consumers use dietary-supplement label information. FAC has appointed an internal working group to develop recommendations for the full advisory panel.
  
• The FDA should encourage research about dietary supplements. FDA agrees that additional research should be undertaken to assess the relationships between dietary supplements and the maintenance of health and/or prevention of disease, and it will continue to provide assistance and guidance for such research by industry and other federal agencies. The FDA will also continue working closely with the Office of Dietary Supplements of the National Institutes of Health.
  

This Historic April 27^th FDA Proposal for Rules to Make Claims for Dietary Supplements more truthful, informative, reliable and uniform are monumental and we, the people, must honor and acknowledge when we live during a period where the Declaration of Independence and our Constitution can be seen in action!   This article calls out to those financially responsible individuals in the Business world to find,  philanthropically donate or promote support for greater allocation of funding to the United States Food and Drug Administration.

The law allows, without FDA's authorization, claims that are truthful and not misleading about the effect of a dietary supplement on the structure or function of the body for maintenance of good health and nutrition. Under the proposal, such permissible structure/function claims can state, for example, that the product "promotes regularity," also "helps maintain cardiovascular health," or "supports the immune system."

The proposal also identifies many types of so-called "disease claims" that are prohibited under DSHEA. In general, these claims state or imply benefits for a disease, which the proposal in part defines as any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system of the body that is manifested by a characteristic set of signs or symptoms. Under the proposal, dietary supplements that expressly or implicitly claim to diagnose, treat, prevent or cure a disease continue to be regarded as drugs, and have to meet the safety and effectiveness standards for drugs under the Food Drug and Cosmetic Act (FDCA). Examples of such prohibited disease claims for a dietary supplement include "protects against cancer," "treats hot flashes," and "reduces nausea associated with chemotherapy."

The proposal also describes various means -- such as product names, vignettes, graphics and citations -- by which a dietary supplement could make or imply a disease claim prohibited under DSHEA.

"Consumers want access to dietary supplements, but also need reliable information about the products they are consuming," said William Schultz, FDA's Deputy Commissioner for Policy. "By clarifying for manufactures what types of claims can and cannot be made on a dietary supplement label, this new proposal helps consumers make more informed and wiser choices."

Today's proposal and FDA's response to the Commission's report will be published next week in the Federal Register. The agency welcomes written comments and recommendations on the proposed criteria and other aspects of the proposal, and
will accept such communication for the next 120 days. The agency will also accept written comments on its response to the Commission on Dietary Supplement Labels.  Please address all comments to:

Dockets Management Branch (HFS-456)
Food and Drug Administration
12420 Parklawn Dr., Room 1-23
Rockville, MD 20857

"A civilization which develops only on its material side, and not in corresponding measure on its mental and spiritual side, is like a vessel with a defective steering gear" Albert Schweitzer

- Scott Neff MSOM DC DABCO ABDA IME DABFE FABFE FFAAJTS Badges # 473 & CFE # 20315