Public Policy Center

Federal Government Has Authority To Regulate Ephedra Products

I. THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (FDC ACT)

The FDC Act authorizes the Food and Drug Administration (FDA) to regulate drugs, devices, foods and cosmetics, to an appropriate degree for each category. Unlike most drugs and devices, foods, including dietary supplements, do not require pre-market approval because of their inherent safety and history of use. Rather, the law requires that manufacturers of dietary supplements, prior to marketing, submit data to the FDA for any new dietary ingredient that is not already present in the food supply.

Congress established the current requirements for dietary supplements for two primary reasons. The first reason was to authorize "good manufacturing practice" and other regulations tailored to specifically to address the manufacture and marketing of dietary supplements. The second reason was to correct FDA's prior misuse of its authority (describe by one United States Court as "Alice-In-Wonderland" thinking) to keep supplements off the market,

In the early 1990s, Congress took notice of FDA's misuse of its authority. FDA's restrictive policy on dietary supplements led to a strong effort to gain legislative relief, culminating in the Dietary Supplement Health and Education Act of 1994 (DSHEA). This new legislation added new provisions to the law to make certain that FDA did not misuse the authority granted in the FDC Act in a way that was contrary to the intent of Congress and detrimental to the public health.

THE DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT (DSHEA)

DSHEA reaffirms the Federal Food, Drug, and Cosmetic Act and provides FDA with substantial and sufficient authority to protect the public's health and well-being. FDA's authority to remove any product that is deemed to be dangerous from the market is clear. FDA can remove products from the market for the following reasons:

Poses A Significant and Unreasonable Risk ‚ FDA does not have to prove that a product actually harmed anyone, but simply that it presents a "significant or unreasonable risk" of illness or injury. Statistics regarding Ephedra's consumption in this country and the scientific evidence on the safety and efficacy of Ephedra dietary supplements demonstrate that they do not pose a significant or unreasonable risk.

Contains Poisonous or Deleterious Substances ‚ FDA does not have to prove that a Ephedra product has a substance that will injure, but simply that it MAY render injury under the recommended or suggested conditions indicated on a product's label. Science and the history of use of Ephedra in this country show that Ephedra dietary supplements, when used according to industry standards, which have been adopted as law in several states, are safe.

Is Unfit For Food ‚ FDA has authority to stop the marketing of any dietary supplement that the agency believes is not fit for human consumption. There is no evidence whatsoever that Ephedra is unfit for human consumption. In fact, it has been safely consumed by humans for over 5000 years.

Makes Drug Claims ‚ If a dietary supplement's label indicates that the product can diagnose, cure, mitigate, treat or prevent a disease, then it is clearly being represented as a "drug" and is no longer considered a dietary supplement. Responsible manufacturers have labels, warnings, and directions for use for their products and are careful not to represent their products as drugs.

Lacks Truthful and Informative Labeling ‚ By law, all dietary supplement products must contain extensive informative labeling, including detailed information about the nutrients in the product, such as name and quantity of all ingredients in the product and the name and place of business of the company, for example. Industry supports enforcement efforts of this provision. Recently the Secretary of Health and Human Services announced enforcement efforts to remove products that were marketed to minors and for illicit purposes. Industry has consistently urged FDA to use its enforcement powers to remove such products from the marketplace.

A dietary supplement that is "adulterated" or "misbranded," or that bears an unauthorized drug claim is subject to seizure, condemnation and destruction. DSHEA included additional safety requirements regarding the introduction of new dietary ingredients. The law clarified that dietary supplement ingredients marketed prior to October 15, 1994 do not require pre-market approval. However, manufacturers marketing a new dietary supplement ingredient after this date must submit safety information on the new dietary ingredient to FDA.

Finally, DSHEA provides the Secretary of Health and Human Services with the authority to remove ANY dietary supplement or dietary supplement ingredient that poses an "imminent hazard." If the HHS Secretary makes this decision, the government must conduct an administrative review of the case and the product cannot be sold to the public. THIS IS A POWER THAT THE GOVERNMENT HAS OVER NO OTHER FOOD.

For a more information, you can read "FDA Has Substantial and Sufficient Authority To Regulate Dietary Supplements" in the Food and Drug Law Journal, Volume 57, Number 1, 2002.

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The History Of FDA's Opposition To Ephedra

I. FDA PROPOSES EPHEDRA REGULATIONS
On June 4, 1997, the FDA proposed severe limits on the manufacture and use of Ephedra that would have rendered Ephedra products useless for their intended purposes. The proposal prohibited claims that Ephedra products are useful for weight loss, thereby essentially banning Ephedra.

Despite billions of servings consumed (see industry survey), the FDA based its decision regarding Ephedra on some 800 adverse event reports (AERs) received by the agency between 1993 and 1997. An AER is a report made to the FDA by a consumer or health care professional. These reports contain information of widely varying degrees of quality concerning adverse events that may be related to the ingestion of a product. While widely reported as a basis for concern, the FDA itself admits that these reports are subjective, do not represent scientific data, cannot be used as a basis for scientific regulation, and ordinarily cannot be used to determine if the adverse event was caused by the product in question.

Despite its own conclusion that AERs are unreliable, the FDA chose to base its proposal to regulate Ephedra on these reports. Congressional inquiry into the FDA's decision revealed another big problem ‚ that FDA never reviewed the Ephedra-related adverse event reports to attempt to determine whether there was any possible link between the adverse event and the consumption of Ephedra. In fact, research shows that in its final decision on Ephedra, the FDA cited a number of AERs that had no relation to Ephedra products. These reports remain in FDA's system as "associated with" Ephedra consumption even though FDA has never reviewed them and most, on their face, could not possibly have been caused by Ephedra.

In addition, in the proposal, the FDA rejected successful clinical studies showing that ephedrine was safe to use in the treatment of obesity. FDA argued that obese individuals may be less sensitive to ephedrine, which is why, the agency believed, that they are not adversely affected. The FDA cited no studies and had no scientific basis to support this theory.

II. CONGRESS AND OTHER U.S. GOVERNMENT AGENCIES QUESTION THE FDA'S EPHEDRA DECISION

A. SMALL BUSINESS ADMINISTRATION (SBA) QUESTIONS

The SBA examined the FDA's proposed rule and sent a letter urging its withdrawal on March 17, 2000 because of a lack of valid scientific evidence. In the letter, the SBA raised serious questions about the FDA's cost/benefit analysis and FDA's underestimation of the number of small businesses that would be impacted. Click here to read the letter.

B. CONGRESSIONAL CONCERN

The SBA comments were instrumental in activating congressional involvement with FDA's Ephedra proposal. The House Committee on Science requested the Government Accounting Office (GAO) to conduct an audit of FDA's scientific basis for the proposed serving limits and duration limit. The Committee on Science also required that the GAO examine the quality of the cost/benefit analysis FDA had included to justify the need for a regulation.

C. GENERAL ACCOUNTING OFFICE INQUIRY

The GAO concluded that FDA did not have a sufficient scientific basis for the serving and duration limits that the agency proposed and that the cost/benefit analysis was deficient in several important ways. Regarding FDA's reliance on just 13 AERs to establish a serving limit, GAO stated that "[o]ur review of these 13 AERs found numerous problems that raise questions about the causal relationship between ingestion of the implicated product and the adverse events observed."

The GAO revealed its findings in the August 1999 report titled "Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids."

III. THE FDA CONCEDES ITS ERRORS

Increased criticism by policy-makers and the general public following the GAO report, and the recognition that the agency could not move forward with a proposed rule that had no scientific basis, forced the FDA to withdraw significant portions of its proposed rule that would have effectively banned Ephedra products.

IV. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC MEETING ON EPHEDRA SAFETY

On August 8-9, 2000, the Department of Health and Human Services (HHS) Office on Women's Health (OWH) sponsored a public meeting to discuss the safety of dietary supplements containing ephedrine alkaloids. This meeting stemmed from the criticisms contained in the July 1999 GAO report and FDA's withdrawal of the substantive portions of its proposed rule.

Click here to read a summary of the meeting.

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The Ephedra Industry Wants A National Standard To Ensure The Safe Use Of Ephedra Products

I. SCIENCE-BASED NATIONAL STANDARD FOR RESPONSIBLE EPHEDRA USE

The Ephedra industry strongly supports a national standard for Ephedra products. The industry has already created guidelines for its members and introduced and supported legislation in several states to establish legal requirements for a national standard. Those states include Ohio, Washington, Hawaii, Nebraska and Michigan.

II. THE FDA'S RESPONSE TO INDUSTRY'S REQUEST FOR A NATIONAL EPHEDRA STANDARD

In October 2000 the major trade associations representing the dietary supplement industry petitioned the FDA to adopt these national standards and to take action against any company that violates them. FDA has failed to respond in a meaningful way and has only said, "we have not been able to reach a decision on [the] petition within 180 days . . . because of the complexity and public health significance of the issues . . ." Although it has been over a year, FDA has still failed to respond or comment on Industry's petition.

To read industry's petition, click the link here

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