Natural Foods Merchandiser

FDA Releases Final Ephedra Rule

On April 12, the sale of any ephedra supplements will be against the law, although the U.S. Food and Drug Administration has urged consumers to cease using these products immediately.

The FDA?s final rule on ephedra, which was published Feb. 11, gives retailers 60 days to remove all products containing ephedra from their shelves. But in a victory for tea makers and practitioners of traditional Chinese medicine, teas and TCM products containing ephedra will be exempt from the rule, as they are generally not marketed as dietary supplements and contain low concentrations of ephedra.

The final rule, which runs 263 pages, also clarifies the framework the FDA will use in the future to determine whether a dietary supplement ingredient presents an unreasonable risk to consumers. The outright ban on all dietary supplements containing ephedra and ephedrine alkaloids marks the first instance since the 1994 passage of the Dietary Supplements Health and Education Act that the FDA has removed a previously accepted ingredient from the market.

Many manufacturers have voluntarily reformulated their products—particularly weight-loss supplements, the primary use for ephedra—with other botanicals in anticipation of the ban. David D?Arcangelo, president of Advantage Marketing Systems, which has already released ephedra-free formulations of its existing product line, said AMS ?does not anticipate that the FDA?s ... ban on ephedra will materially impact its financial condition or its expected profitability.?

The sheer volume of weight-loss supplements sales affected by the ban makes it almost certain that some manufacturers will take legal action against the FDA, said Michael McGuffin, American Herbal Products Association president.

?We anticipate it will be challenged,? said Laura Alvey, FDA spokeswoman, ?so we have to make sure that every T is crossed and every I is dotted. This is the first time FDA has taken such an action, and it will be laying the framework for all future actions.?

In the long run, perhaps more important than the specific issue of ephedra is whether the ban is the first salvo in an attack on DSHEA itself. When the impending action against ephedra was announced in December 2003, Health and Human Services Secretary Tommy Thompson expressed dissatisfaction with the ?burden of proof? provision of DSHEA. ?We have to prove scientifically that [certain supplements ingredients are] unsafe,? he said. ?Now, Congress should take a look at whether they want that to continue.?

And in a speech Jan. 20, FDA Commissioner Mark McClellan mentioned other supplements ingredients that the agency has targeted for further study. ?We are particularly concerned about the possible health risks of the growing number of ephedra alternatives now on the market,? he said, listing bitter orange (citrus aurantium), aristolochic acid and usnic acid specifically.

?I can only guess he mentioned these ingredients because they are ephedra substitutes,? said Alvey. ?It?s premature to suggest that these are the next ones in line; they?re just examples of the types of supplements we want to develop more information on.?

But AHPA?s McGuffin disagreed. ?That seems to me to be uninformed and disingenuous,? he said. He cited FDA recalls of products containing aristolochic acid within the past few years, as well as the recall of a product marketed by Lipokinetix containing usnic acid—an extract of the lichen usea—in the form of sodium usneate.

Both ingredients, McGuffin said, can cause liver damage, but neither is widely available in supplements. ?I believe the commissioner was misinformed [in characterizing these ingredients as ephedra substitutes],? he said. ?There is no ephedra-free herbal product where the replacement ingredient is aristolochia; it?s simply not true.?

?It?s not a big issue, because very few products, if any, have aristolochia in them,? said Mark Blumenthal, American Botanical Council executive director. ?The FDA will probably scrutinize these herbs, but the impact of that scrutiny will be insignificant on our industry. The ban is already de facto.?

The third item on the list, bitter orange (the main ingredient in marmalade), is widely used in the dietary supplements industry, and its active ingredient, sinephrine, is chemically similar to ephedrine.

?Citrus aurantium is a botanical people are using as an ephedra substitute, along with extract of green tea and garcinia cambogia,? said McGuffin. ?Critics have called sinephrine ephedrine?s kissing cousin. That may be true, but chemical similarity doesn?t by itself indicate biochemical similarity. Carbon dioxide and carbon monoxide are also similar; one?s pleasant, one?s deadly.?

Even among herbs that can be commonly found in supplements, it may be difficult for the FDA to clearly demonstrate that a particular ingredient is unsafe. The action against ephedra was seven years in the making, in spite of numerous adverse-event reports to support the FDA?s position.

?Millions of people have been using ephedra products safely and successfully,? Blumenthal said. ?And ephedra is not representative of other herbs. Very few have the dynamic effect of ephedra. Because of its high pharmacological activity, there is a corresponding increase in adverse events.?

What It Means to Retailers

The most pressing question for retailers who still possess a stock of ephedra-containing weight-loss products is what to do with the products between now and April 12, when the ban takes effect. ?Having worked with both retailers and manufacturers, I?m not aware of any standard industry practice,? said Michael McGuffin, president of the American Herbal Products Association. ?This is essentially an industry-wide recall that goes across a lot of brands, and it should be as efficient as possible.?

McGuffin suggested that the most efficient and least wasteful way to get the product off shelves is to do the returns on paper—that is, for the retailer to destroy or throw away the product and simply ask the manufacturer for a credit for the product destroyed. However, manufacturers may request the actual product be shipped back before credit is issued, because of liability concerns. ?A brand might want to incur the extra expense of shipping to be absolutely certain of the destruction of the product,? McGuffin said.

Starkie Sowers, director of training and development for the Riverside, Calif.-based chain Clark?s Nutritional Centers, says any leftover stock has already sold to customers anticipating the ban, but they had been prepared to return it to the manufacturers. ?We were proactive,? Sowers said. ?We were ready to [return the merchandise for cash back]. But we saw it coming, we were able to make the adjustment and we didn?t sit with anything on the shelves.?

Natural Foods Merchandiser volume XXV/number 3/p. 13, 18

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