Ephedra Marketing, Availability Debated At Government Reform Hearing

FDA's Center for Food Safety & Applied Nutrition has reached a standoff with industry over how best to regulate ephedrine alkaloid-containing dietary supplements, CFSAN Director Joseph Levitt stated during a House Government Reform Committee hearing on supplement regulation March 20.

Committee Chairman Dan Burton (R-Ind.) had questioned Levitt about the steps FDA has taken to resolve the outstanding issues on ephedra, specifically asking whether the agency's dialogue with industry has proven useful.

Levitt responded that FDA and industry have "reach[ed] an impasse," noting when FDA meets with industry, "we tend to ask what scientific studies do you have to support what you are proposing. And they ask us what evidence we have to prevent what they are proposing."

The center director explained the public meeting held by the HHS Office of Women's Health in August to hear evidence on the safety and efficacy of ephedra-containing dietary supplements was meant both to help FDA's dialogue with industry and to "be even-handed" (¹ (Also see "Ephedrine Alkaloid Serious AEs Consistent With Background Levels - Industry" - Pink Sheet, 14 Aug, 2000.)).

Levitt added CFSAN is working with the National Institutes of Health's Office of Dietary Supplements and National Center for Complementary & Alternative Medicine "on what research they might be able to fund that could help provide the answers to these questions."

The topic of ephedra arose throughout the hearing, as Burton questioned each of the witnesses about their views on the botanical.

Samuel Benjamin, MD, chairman of InVite Health, said he "cannot support the use of ephedra" for weight loss, noting the herbal is not used in China for that purpose but rather for acute bronchitis or asthma.

Karl Riedel, CEO of Nature's Life and member of the U.S. delegation to Codex, noted his company does not sell ephedra products, but suggested FDA would better address ephedra by defining the term "energy" to help clarify the herbal's primary use as a thermogenic dietary supplement.

Internationally, Codex recognizes "energy" only as a caloric value and energy claims must be based on caloric value, Riedel explained.

"It is in the best interest of consumers to have the term defined" in order to distinguish the caloric value of macronutrients such as carbohydrates from the stimulating effects of substances such as ephedra and caffeine, he maintained.

Other industry representatives disagreed. Utah Natural Products Alliance Executive Director Loren Israelson proposed a trade association-drafted guidance on the appropriate marketing of ephedra supplements "be reconsidered by the agency."

"The single most important issue [is] the dosage amounts of ephedra permitted per dose and per day," he stated.

However, Public Citizen Health Research Group Director Sidney Wolfe, MD, compared the herbal to phenylpropanolamine and said ephedra "should come off the market."

"The fact that ephedra is regulated, or not able to be as well regulated because it falls under DSHEA, as PPA did falling under the [FD&C] Act, it should not be a variable in the face of all the evidence in taking it off the market," he asserted.

In November, FDA recommended manufacturers of cough/cold products containing PPA withdraw the items from the market due to research linking the ingredient to an increased risk of hemorrhagic stroke (² (Also see "PPA AER Underreporting Probable, NDAC Says In Vote Against GRAS Status" - Pink Sheet, 23 Oct, 2000.)).

Wolfe further suggested legislation be proposed "to rapidly lessen the damage being done by" the Dietary Supplement Health & Education Act.

The legislation could require supplement manufacturers to report adverse events to FDA and list potential health risks on product labeling, Wolfe suggested.

"Identification of the raw ingredients and the source, by country, for each of the ingredients in each product," also could be mandated, he said.

The measure partly is necessary, Wolfe maintained, "to ensure that BSE-contaminated recycled cow organs do not appear on the shelves in this country as dietary supplements."

Wolfe also suggested FDA "be appropriated...funds to purchase the entire dietary supplement database of the American Association of Poison Control Centers. At the present, only the ephedra alkaloid cases have been contracted for by the FDA."

However, Levitt noted CFSAN has "little latitude" to shift appropriated funds toward supplement activities due to limitations created by its budget.

"In recent years, the budget has become increasingly earmarked" for food safety, Levitt said. "Our monies are increasingly restricted and not...flexible and there are very strict rules about to what extent the agency is able to move money between programs."

At a National Nutritional Foods Association seminar in Washington, D.C. March 19, CFSAN Office of Nutritional Products, Labeling & Dietary Supplements Director Christine Lewis, PhD, reiterated additional funding is needed to oversee the supplement market.

"In order to implement the dietary supplement strategic plan, we need more help in the field, we need more research dollars for NIH, we need more money for Office of Chief Counsel lawyers," she said.

Levitt pointed out CFSAN's request for $2.5 mil. to modernize its dietary supplement adverse event monitoring system has been denied the past two years.

"We very much want to move and modernize our system...and we are hopeful that one of these years, the funding will come through for what we have requested," he stated.

Levitt agreed with Burton's assessment that Congress "is putting fences around your money" and needs to appropriate additional funds specifically for dietary supplements to remedy the situation.

Burton scheduled the hearing on dietary supplements as the first in what could become a series of hearings during the 107th Congress.