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Stephen L. DeFelice, MD

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Regulatory Affairs

Proceedings of the Symposium:

A Comparison of the U.S., European & Japanese Nutraceutical Health and Medical Claim Rules

Published in Regulatory Affairs, Vol. 5, Summer 1993

Published by the Regulatory Affairs Professional Society, Meraland



Stephen L. DeFelice

The Nutraceutical Revolution: Global Implications
Stephen L. DeFelice

The FDA's Rules On Health Claims For Foods - Including The New 1993 Regulations Issued Under The Nutrition Labeling And Education Act
Stephen H. McNamara

The Nutraceutical Rules: Health And Medical Claims: "Food For Specified Health Use" In Japan
Tadayasu Furukawa

Case Studies: International Comparisons:

Animal Dietary Supplement In U.S. vs. Drug In Europe: Fish Oil
Gerard Pilley

Plant Dietary Supplement: Garlic
Lyn Ciocca

Food Phytochemical Pharmacology - The Basis For Designer Food Development
Herbert F. Pierson, Jr.

Cereals: All-Bran And Heartwise
Victor L. Fulgoni, III

Food Additive: Olestra
Michael D. Young

Paul A. Lachance

Nutraceuticals And The Orphan Drug Act
Abbey S. Meyers

The Foundation's Nutraceutical Proposal Modeled On The Orphan Drug Act
Stephen L. DeFelice

The Next Generation Of Food Products: Healthy Foods
Hercules A. Segalas

Points To Consider

Commissioner's Industry Exchange Meetings Pre-Approval Inspection Program


Questions and Answers

Guideline On General Principles Of Process Validation

Guide To Inspection Of Bulk Pharmaceutical Chemicals



Stephen L. DeFelice, M.D.*

A nutraceutical is any substance that can be considered a food or part of a food and provides medical or health benefits, including the prevention and treatment of disease. Such products range from traditional foods, isolated nutrients, dietary supplements and diets, to genetically engineered "designer" foods, herbal products, and processed foods such as cereals, soups, and beverages.

The Foundation for Innovation in Medicine coined the term nutraceutical to (a) give an identity to a new health sector that offers enormous health and medical benefits to the consumer, and (b) to encourage the creation of a new regulatory category.

In the face of current events in Washington and worldwide, the U.S. scientific community, food and drug industries, and government policy leaders have arrived at a crossroads. Never have the times been better - or more urgent- for the introduction of much-needed economic and regulatory reforms to establish conditions for the research-based commercial development of nutraceuticals; the increasing array of food and nutritional products with significant medical and health benefits.

As a result of the worldwide nutraceutical revolution, the uses of foods are rapidly moving toward the pharmaceutical sector and competing with drugs on a global basis. Moreover, the dramatically accelerating phenomenon of university-based clinical discoveries in this area are now posing a multitude of issues and opportunities that are already being addressed by the rest of the developed world.

Perhaps the best news is that our country is now, both in spirit and legislative focus, capable of establishing common-sense ground rules that will enable these important discoveries to be properly developed, evaluated, and made available to the American public. The new food regulations proposed by the Food and Drug Administration (FDA), while failing to address these issues, nonetheless have paved the way for the adoption of additional economic and regulatory concepts which do. Meanwhile, the FDA has increasingly acknowledged that its mandate today is not only to keep unsafe therapies off the market, but to provide a responsible means of introducing safe and effective health advances onto the market as well.

Of equal importance, let there be no doubt that Europe and Japan are well ahead of the United States in recognizing this revolutionary new product category. And let there be no doubt that America's global competitiveness will dramatically fall behind in yet another important area of new technology unless urgently needed economic and regulatory reforms are expeditiously introduced in this country.

This following papers were presented at a seminar on "A Comparison Of The U.S., European & Japanese Nutraceutical Health And Medical Claim Rules," which the Foundation organized in order to present its recommendations regarding a new nutraceutical regulatory category as an addition to existing ones, where a sponsor can, at costs generally substantially lower than those associated with pharmaceuticals and food additives, obtain an exclusive health or medical claim. The rationale is based on the economic principles that led to the highly successful Orphan Drug Act. As part of the program, the case method was used regarding designer foods, plant and animal dietary supplements, processed foods - cereal, and a food additive.

Following the seminar, Senator Orrin Hatch (R-UT) and Representative Bill Richardson (D-NM) introduced, on April 7, 1993, The Dietary Supplement Health and Education Act of 1993 (S 784 and HR 1709).

Both bills recognize the valuable role nutritional supplements play in health promotion. Further, they ensure the availability of safe, quality supplements along with truthful and nonmisleading information about their benefits.

"In our free market society, consumers should be able to purchase dietary supplements, and companies should be able to sell these products so long as the labeling and advertising are truthful, nonmisieading, and there exists a reasonable scientific basis for product claims," Sen. Hatch said in introducing the Dietary Supplement Health and Education Act (S 784).

"Dietary supplements still lack an appropriate regulatory framework that will allow appropriate health claims," Rep. Richardson said of his version of the Dietary Supplement Health and Education Act (HR 1709). "We need a standard that will allow truthful, nonmisleading health claims based upon a reasonable level of scientific evidence."

Both Sen. Hatch and Rep. Richardson cited health care reform and prevention in support of their proposed supplement bills. "At a time when America spends over $2 billion a day on health care, prevention is the best and most effective form of cost control," Sen. Hatch said.

Primary Senate sponsors of the supplement bill are Sen. Harry Reid (D-NV), Sen. Malcolm Wallop (RWY) and Sen. Frank Murkowski (R-AK). Primary House sponsors of the bill are Rep. Sherwood Boehlert (R-NY), Rep. John Boehner (R-OH), Rep. Rich Boucher (D-VA), Rep. Martin Frost (D-TX), Rep. Ralph Hall (D-TX), Rep. James Inhofe (R-OK), Rep. Frank Pallone (D-NJ), Rep. Nancy Pelosi (DCA), Rep. Collin Peterson (D-MN), Rep. Steve Schiff (R-NM), Rep. Ed Towns (D-NY) and Rep. Fred Upton (R-MI),

The Council for Responsible Nutrition (CRN), an association of the nutritional supplements, ingredients, and other nutritional products industry, analyzed the two bills and prepared the following summary.

Dietary Supplement Definition. Both the Hatch and Richardson bills define supplements to include vitamins, minerals, herbs, amino acids or other ingredients, or their extracts or concentrates. Also included are tablets, capsules, powders, softgels, or other delivery forms, including liquids, providing they are not represented as conventional foods or as the sole item of a meal or diet. Both bills excluded supplement ingredients from the Food, Drug, and Cosmetic (FDC) Act's definition of food additives. In addition, the Hatch bill amends the drug definition in the FDC Act to exclude dietary supplements.

Dietary Supplement Safety. In place of food additive authority, both Hatch and Richardson would establish special procedures regarding supplement safety. The bills would amend the FDC Act to define a supplement as adulterated if it contains an ingredient determined by the FDA to present a "substantial and unreasonable risk of illness or injury." A supplement would be considered adulterated if the manufacturer has not adequately substantiated safety through a history of safe use or through scientific studies.

Richardson would also declare a supplement to be adulterated if the FDA was not notified of a significant change in manufacturing or of "potential problems of safety or contamination affecting such practice." The bill would also require the FDA to establish regulations within 18 months requiring notification of changes in manufacturing practices or potential safety or contamination problems. These requirements would not affect routine changes in procedures in accordance with good manufacturing practices.

Hatch would also require the proposed office of dietary supplements to study the significance of changes in raw material manufacturing practices.

Further, if the National Academy of Sciences has established a recommended dietary allowance (RDA) or an estimated safe and adequate dietary intake level (ESADDI) for a substance, it will have met the safety requirements.

Office of Dietary Supplements. Both bills would establish an office of dietary supplements within the National Institutes of Health. The office would explore the role of supplements in improving health, promote scientific study of the benefits of supplements, and advise other government agencies about issues relating to supplements.

Dietary Intake Standards. Both the Hatch and Richardson bills mandate the FDA to establish label reference standards for vitamins and minerals at levels that "promote optimal health and minimize the risk of disease." According to the bills, these amounts shall be no less than the U.S. recommended daily allowance for the most vulnerable age or sex group. Until new standards are in place, the U.S. RDA will remain in effect.

Health Claims & Pre-Notification. Both bills permit a health claim if it accurately represents the state of the scientific evidence between the supplement and a disease. No preclearance by the FDA would be necessary. In addition, if the FDA has permitted a health claim for a nutrient in conventional food, the claim must also be permitted for supplements, unless the FDA has determined that consumption of the nutrients from supplements would not reduce disease risk.

In addition, the Richardson bill would require manufacturers to notify the FDA at least 30 days before making a health claim. Documentation may be submitted with the notification, but the FDA would not be allowed to impose any additional premarket requirement or request further documentation.

Labeling. Both the Hatch and Richardson bills require product labels to list the name and quantity of each ingredient intended for use as a dietary supplement, with an exception for a quantitative listing of proprietary blends. A product would be misbranded if it fails to meet any quality standard it claims to meet.

Both bills would extend the protection provided by the Rogers Proxmire amendment for vitamins and minerals to other dietary supplements under the FDC Act. The Hatch bill allows for hearings or judicial review of FDA warning letters and seizures, while the Richardson bill would amend the FDC Act to allow for administrative appeal or judicial reviews.

* Dr. DeFelice is Chairman, The Foundation for Innovation in Medicine, Cranford, New Jersey This introduction was specifically written to introduce the papers that were presented at The Foundation For Innovation In Medicine's seminar, "A Comparison Of The U.S., European & Japanese Nutraceutical Health And Medical Claim Rules," New York City, NY (Jan. 13-14, 1993).




I seem to have a penchant for writing in the summer - it has been a year since I last shared my thoughts with you in an editorial but in that year we have been working to bring you a variety of timely articles on topics of interest to Regulatory Affairs Professionals worldwide. I hope that we have succeeded in that goal and that you have found the articles to be of lasting interest.


In this issue we continue to focus on matters of current interest by publishing the proceedings of a meeting held by the Foundation for Innovation in Medicine in January 1993 on the subject of "nutraceuticals". We are also publishing the remainder of the Questions and Answers and Guidelines collected from FDA's first series of Industry Exchange meetings on the pre-approval inspection process for new drugs.


The Chairman of the Foundation for Innovation in Medicine, Stephen L. DeFelice, M.D., coined the term nutraceutical, which he defines and promotes as any substance that can be considered a food or part of a food and provides medical or health benefits, including the prevention and treatment of disease, to (a) give an identity to a new health sector that offers enormous health and medical benefits to the consumer, and (b) to encourage the creation of a new regulatory category.


It is important to note that the issue of health claims for foods is controversial and The Regulatory Affairs Professionals Society takes no special position on this matter. While the FDA does allow some health claims under its new Nutrition Labeling and Education Act regulations the approved claims are limited. If a company wants to state on its package that its product has a health benefit beyond those provided for in the regulations it must undertake the often expensive research to prove it. The FDA's point of view is aptly summed up by Dr. John Venderveen, Director of the Office of Plant and Dairy Foods and Beverages who has stated that, "We are very concerned that we don't put together a message that promises more than is there. We can't say calcium will prevent osteoporosis. What can be said, under the new law, is that calcium can help growing people reach peak bone mass and delay the onset of osteoporosis, a painful disease of brittle bones." The FDA says the system already in place is sufficient and protects the public from misleading claims because if there is "substantial agreement" on its validity among experts on a new claim, it will be allowed. However, many food manufacturers believe the new law and regulations fail to provide enough incentive or protection to companies and they want a mechanism for exclusivity for their claims before they will commit monies to carryout the necessary research.

Further complicating this issue, on April 7, 1993, Senator Orrin Hatch (R-UT) and Representative Bill Richardson (D-NM) introduced The Diet

ary Supplement Health and Education Act of 1993 (S 784 and HR 1709). Both bills recognize the role nutritional supplements play in health promotion. Further, they ensure the availability of safe, quality supplements along with truthful and nonmisleading information about their benefits. It is clear that the discussion on "nutraceuticals" is far from over!

It is my hope that the articles published in this issue will not only be of interest but will provide the impetus for you to put pen to paper and send in your own views and experiences on this subject and, of course, any other current topics. I encourage you to use this forum for the benefit of your fellow Regulatory Affairs Professionals.

Joseph Paul Hile