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DIETARY SUPPLEMENT REGULATION "BALANCE" URGED BY REP. DURBIN

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT REGULATION "BALANCE" URGED BY REP. DURBIN in his opening statement at an Oct. 18 hearing before the Illinois Democrat's House Appropriations/agriculture subcommittee, which appropriates funds for FDA. Rep. Richard Durbin called on the agency and the dietary supplement industry to work for a "balance between ensuring the safety and accurate labeling of dietary supplements while protecting the American consumer's right to choose." Durbin asserted that "many of the [dietary supplement] products sold are at the cutting edge of modem thinking on the health and quality of our life" while other supplement products on the market "are worthless and dangerous." He also suggested that "there have been excesses by [FDA] and there have certainly been excesses by the dietary supplement industry as they have lobbied Capitol Hill." Durbin said his subcommittee would be "looking for a balance -- not a consensus -- but a balance of viewpoints in this emotional issue." Durbin and six other subcommittee members who stayed for the entire six-and-a-half-hour hearing -- Reps. Joe Skeen (R-N.M.), John Myers (R-Ind.), James Walsh (R-N.Y.), Rosa DeLauro (D-Conn.), Ed Pastor (D-Ariz.) and Pete Peterson (D-Fla.) -- heard from dietary supplement bill sponsors Sen. Orrin Hatch (R-Utah) and Reps. Bill Richardson (D-N.M.) and Elton Gallegly (R-Calif); FDA Commissioner David Kessler; and industry reps from the Council for Responsible Nutrition, the National Nutritional Foods Association, the Utah Natural Products Alliance and the National Health Alliance. The subcommittee also heard from victims of L-tryptophan- induced eosinophilia myalgia syndrome and various consumer groups including the American Association of Retired Persons, the Consumers Union and the Consumer Coalition for Health Choices. FDA Commissioner David Kessler suggested to Durbin that "a sensible middle ground" would be to "provide access" to dietary supplements, but "don't allow [health] claims that are not substantiated." For example, "if someone wants to go put sawdust in a bottle and sell it for $ 14, it's okay with me as long as they don't make a claim that can't be supported," such as that it is "useful to treat or prevent cancer, heart disease, diabetes [or] arthritis," Kessler remarked. "That's where I draw the line, when supplements are really being sold as drugs in disguised." The commissioner asserted that the "dietary supplement industry is essentially unregulated today," adding that the "marketplace is awash in unsubstantiated claims." Kessler explained that "for every unsubstantiated claim for a serious disease that we catch, there are many more unfortunately that we simply don't have the resources to do anything about," and "for every dietary supplement on the market that has some value, unfortunately, there's 100 or even more out there that are worthless." There is "an issue of credibility here, and the dietary supplement industry I believe ought to be concerned about it," the FDA commissioner pronounced. Kessler called the subcommittee's attention to brochures disseminated by certain industry groups that say: "Don't let FDA take your vitamins away." Using the hearing as a podium, Kessler declared: "Let me say absolutely [and] unequivocally that those statements are false. FDA is not out to deny anyone access to vitamins and minerals -- please tell your constituents that." Kessler also spoke out against allegations that FDA is "trying to put the health food industry out of business." Later during the hearing, CRN President J. B. Cordaro questioned Kessler's statement that it is permissible to market a product as long as no health claims are made. "I think that that's backwards," Cordaro asserted. "The manufacturer ought to be allowed to tell the consumer what the value of that product is and they need to be held accountable for being able to substantiate what is on that label." He also challenged Kessler's assertion that the industry is unregulated, maintaining that CRN members follow a "rigorous code of ethics," adhere to food good manufacturing practices and are working with USP to develop dissolution standards. During the hearing, Durbin pointed out several times that the Hatch and Richardson bills would put the burden on FDA to prove whether dietary supplement labels carry misleading claims. Noting that this "is a big change and it's one that we shouldn't look at lightly," Durbin asked the FDA commissioner to comment on this provision of the bill. Congress "could not appropriate enough money for us to be able to go and make the case against each and every company," Kessler replied. "It's an enormous burden you're talking about," including "enormous investigation costs" that would ultimately "be placed on the taxpayer." Gesturing to a row of dietary supplement products he had placed on the dais, Durbin asked Kessler whether those products making unsubstantiated health claims had been taken off the market. Kessler said that some but not all had been withdrawn, adding: "You could sit there, Mr. Chairman, and rightfully say that FDA is not doing enough" to remove hazardous and misleading products from circulation. Durbin also questioned Hatch, Richardson and Gallegly about the burden their bills would place on FDA to prove that supplement health claims are unsubstantiated. Referring to a "health enhancer" made by Nature's Source, Durbin noted that an accompanying circular "suggests that everyone of us ought to rush out and buy it because . . . it will inhibit reproduction of herpes, measles and the HFV virus in vitro" and will "inhibit the growth of cancer." Under "your bill," Durbin asked, is this the type of product that "could be put on the market and then it would be the FDA's responsibility to prove" that "it does not, in fact, inhibit cancer?" Hatch maintained that "if that product is not what it says it is, the FDA has plenty of authority to take it off the marketplace." He also questioned the appropriateness of putting the "burden of proof" on manufacturers "rather than the FDA, which is supposed to be a scientific agency." Richardson defended the industry's integrity, but acknowledged it has "some bad apples." Returning to the Nature's Source aloe vera product claims during the industry panel, Durbin said he was troubled by the Hatch/Richardson bill's mechanism for regulating health claims. "Under the bill you support," Durbin stated, a company "could put this on the market, send the notice to the FDA 30 days before it hits the market, and then it's up to the FDA to prove them wrong." Moreover, Durbin argued, "if there's somebody out there in your industry that has anything near a cure or palliative for . . . HIV, my guess is that they would have made their move a long time ago" in pursuing FDA approval. "There are pharmaceutical companies across this country investing millions of dollars in an effort to find [a treatment for HIV], realizing if they are successful, there is a vast opportunity for them." To suggest that "aloe vera just might hold the key, I think holds up the kind of false hope that bothers people like me," he charged. "If this is true, for goodness' sake, do something about it through the organized channels; don't tantalize people with these kinds of brochures," Durbin declared. Among other suggestions expressed at the hearing was one by Rep. Peterson, who said that "in looking for the balance . . . perhaps we can look for [separate] categories" of dietary supplements "and treat them differently." Sen. Hatch responded that "we would argue against that because we believe that these products are basically safe."
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