Supplement Industry Urges FDA Action Against Illegal Products

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Washington, DC, April 10, 2000—Dietary supplement industry leaders urged the Food and Drug Administration (FDA) to take swift action against illegal street drug alternatives masquerading as dietary supplements. On April 3, FDA Guidance for Industry: Street Drug Alternatives, acknowledging the agencyœs enforcement authority to seize or issue an injunction against products marketed as substitutes to illegal street drugs.

The dietary supplement industry has repeatedly asked the agency to remove such products from the market, saying product labels invite abuse by promising rapid Æhighsœ and Æeuphoria,œ leading users to increase their dosage until such a Æhighœ occurs.

The American Herbal Products Association, the Council for Responsible Nutrition, the National Nutritional Foods Association, and the Utah Natural Products Alliance responded to the Guidance in an April 7 letter sent to the to FDA's Office of Compliance, Division of Labeling and Nonprescription Drug Compliance.

"The national trade associations of dietary supplement manufacturers, distributors, and retailers are gratified to see that FDAœs new Guidance is so closely aligned with the positions that the responsible center of the industry has consistently taken over the past five years," said the trade group leaders. They added, " Nonetheless, we are concerned that the agency might not act as promptly or forcefully as we believe is appropriate. The Guidance is a first step. If it is not followed by action, it will simply become an artifact. Our industry is being pummeled by headlines denouncing Æherbsœ and Ædietary supplementsœ. The articles are about illegal drug products masquerading as supplements, thus disparaging the entire class of health-promoting supplements that continues to enjoy broad consumer acceptance."

Five years ago, the four trade associations issued a joint statement stating that products marketed as alternatives to illegal Æstreet drugsœ such as Ecstasy (MDMA) are misbranded and adulterated dietary supplements under the Food, Drug, and Cosmetic Act and subject to regulation as controlled substances.More recently, industry representatives met with FDA to urge the agency to adopt a policy that clearly identified "any claims [that] are made that the product may be useful to achieve an altered state of consciousness, euphoria, or as a "'legal' alternative for an illicit drug" as a criterion for recommending legal action against the product.

In their letter, trade association officials notified FDA that an Internet search readily identified companies that may fit the Guidance definition of "street drug alternatives." "The industry is willing to assist FDA in enforcing against these illegal products," said Michael McGuffin, President of the American Herbal Products Association in Silver Spring, MD. "We urge the agency to use its full enforcement authority granted by the Dietary Supplement Health and Education Act to regulate appropriately ingredients marketed as dietary supplements."

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Guidance For Industry: Street Drugs Alternatives

American Herbal Products Association
8484 Georgia Avenue, Suite 370
Silver Spring, Maryland 20910

Council for Responsible Nutrition
1875 Eye Street, N.W., Suite 400
Washington, D.C. 20006-5409

National Nutritional Foods Association
3931 MacArthur Boulevard, Suite 101
Newport Beach, California 92660

Utah Natural Products Alliance
1075 Hollywood Avenue
Salt Lake City, Utah 84105

 

April 7, 2000

Ms. Betty Jones
Acting Director
Office of Compliance
Center for Drug Evaluation & Research (HFD-300)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Ms. Margaret Tart
Acting Director
Division of Labeling and Nonprescription Drug Compliance (HFD-310)
Office of Compliance
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Re: Guidance for Industry: Street Drugs Alternatives

Dear Ms. Jones and Tart:

This letter is in reference to the Guidance for Industry: Street Drug Alternatives prepared by the Office of Compliance, Division of Labeling and Nonprescription Drug Compliance, and published in the Federal Register on April 3, 2000.

The four national trade associations of dietary supplement manufacturers, distributors, and retailers are gratified to see that FDA's new Guidance is so closely aligned with the positions that the responsible center of the industry has consistently taken over the past five years. Nonetheless, we are concerned that the agency might not act as promptly or forcefully as we believe is appropriate. The Guidance is a first step. If it is not followed by action, it will simply become an artifact. Our industry is being pummeled by headlines denouncing "herbs" and "dietary supplements." The articles are about illegal drug products masquerading as supplements, thus disparaging the entire class of health-promoting supplements that continues to enjoy broad consumer acceptance.

Our primary interest in recommending regulatory action was and is based on concern for the safety and health of consumers of these products. As we have stated so many times, products that are labeled and marketed in a manner that invites abuse create an unreasonable risk of illness or injury. We strongly urge FDA to use the full enforcement authority that is acknowledged by the issuance of this Guidance, including seizure and/or injunction, sooner rather than later.

Our four trade associations have for years sought to separate our legally labeled herbal and other dietary supplement products from the unapproved new drugs and misbranded drugs that are the subject of the newly published Guidance. Five years ago, our trade associations issued a Position Statement and Call for Action for the Safe and Appropriate Marketing of Ephedra-Containing Products. In that Statement, the position presented was that the

"outlaw marketing of ephedra-containing products as alternatives to illegal 'street drugs' such as Ecstasy (MDMA) is not considered legitimate. The industry believes that such marketing is illegal under the Controlled Substances Analogue Enforcement Act of 1986, enforced by the Drug Enforcement Administration (DEA), and that products marketed in this way are illegal as misbranded and adulterated dietary supplements under the Food, Drug, and Cosmetic Act. Such products are not intended for use 'to supplement the diet' and their marketing 'presents a significant and unreasonable risk of illness or injury' since their labeling and the entire aura of their promotion encourages abuse. By promising rapid 'highs' and 'euphoria,' users are encouraged specifically or by implication to abuse the product until such a 'high' occurs."

Also in 1996, our trade associations communicated with Senator Alfonse DœAmato to demonstrate that current law gives FDA ample authority to take action against products that are marketed as substitutes to illegal street drugs. In that correspondence, we showed that FDA could use any one of a number of regulatory tools to act against any product that claims to enable users to achieve a "high."

Our efforts to make enforcement against street drug alternatives a priority did not stop with FDA. Two of our associations, the National Nutritional Foods Association (NNFA) and the American Herbal Products Association (AHPA), testified in favor of and supported Ohio legislation enacted in 1996 that made such claims unlawful for ephedra-containing dietary supplements. More recently, in May of 1999, three of our trade groups joined with another in presenting FDA a draft compliance policy guide for dietary supplement products containing ephedrine alkaloids. It was proposed on that date in a meeting with Joseph Levitt, Director, Center for Food Safety and Applied Nutrition, and others, that FDA adopt a policy that clearly identified "any claims [that] are made that the product may be useful to achieve an altered state of consciousness, euphoria, or as a Ælegalœ alternative for an illicit drug" as a criterion for recommending legal action against the product.

In order to assist you in acting promptly on this matter, we have conducted an internet search of the terms "ecstasy," "GHB," and "get high." This search resulted in the identification of three companies that are selling products that may fit the Guidance definition of "street drug alternatives." None of the products identified in this search, claims to contain ephedra or ephedrine. Rather, these goods are now using other dietary ingredients that otherwise have rich histories as health promoting and nourishing supplements.

We request FDA to proceed promptly against any of these that fit the definition of street drug alternatives as defined by the Guidance. If you and your colleagues are not able to locate these product, we would be pleased to meet with you to discuss the results of our search.

Sincerely,
Michael McGuffin
President
American Herbal Products Association

John Cordaro
President & CEO
Council for Responsible Nutrition

Patrick Toomey
President
National Nutritional Foods Association

Loren Israelsen
President
Utah Natural Products Alliance

cc: Joseph A. Levitt (HFS-1)
Christine Lewis (HFS-450)
Jane Axelrad (HFD-5)
William M. Bristow, II (HFA-80)