Supplement industry may challenge FDA rules on ad claims
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www.sltrib.com/business/ci_3298188
By Linda Fantin
The Salt Lake Tribune
It's the morning after the morning-after pill mess and the reputation of the Food and Drug Administration is in shambles.
The agency is supposed to promote and protect the public's health, and 2005 offered evidence of failure on both fronts - from the Vioxx fiasco to the Ephedra entanglement to the embroglio over silicone breast implants to allegations that pro-life politics scuttled over-the-counter sales of the "Plan B" contraception before the scientific review was complete.
Of course, the dietary supplement industry didn't need Plan B to highlight the prickly relationship between politics and science at the FDA.
It's been 12 years since Congress passed the Dietary Supplement Health Education Act, or DSHEA, concluding that consumers should be able to make choices about their health care "based on data from scientific studies of health benefits related to particular dietary supplements."
And for just as long, the FDA has successfully blocked the sellers of vitamins and minerals and herbal remedies from informing consumers about those health benefits by preventing claims that supplements prevent, treat or cure disease.
That's why some in the industry are backing a new bill that would force the FDA to approve such health claims even when there is scant scientific research to support them. The so-called Health Freedom Protection Act also would restrict the Federal Trade Commission's authority to police false and misleading advertising claims.
Even so, the supplement industry is hardly united behind the bill, and supporters acknowledge some aspects of it constitute an overcorrection of sorts, designed to awaken federal regulators. They already have the attention of lawmakers; the bill has 14 co-sponsors, including Utah congressional Republicans Rob Bishop and Chris Cannon.
It is not the first time supplement makers have tattled to Congress, nor is it the first time since 1994 that Congress has tried to neuter the FDA. But in politics and pregnancy, timing is everything, and thanks in large part to the Plan B controversy, the industry's long-time nemesis is weaker and more distracted than ever.
"This is not the first effort, but it is one of the more serious efforts," says Marc Ullman, a New York City attorney who specializes in food, drug and cosmetic law. "There is a political vulnerability there, and FDA has only itself to blame."
That was also was true in the 1980s, when Kellogg launched an advertising campaign that boasted its high-fiber breakfast cereals lowered the risk of colon cancer. Back then such claims were called health "messages" and they were only allowed by drug companies. But there was disagreement among the nation's food cops about whether the FDA had the authority to intervene. So it didn't, says Betty Campbell, a 35-year veteran of the FDA who now advises food and supplement makers about compliance. "It was very controversial."
The FDA's response - or lack thereof - also opened the market to a flood of other health claims, prompting Congress to pass the Nutrition Labeling and Education Act of 1990. The law allowed disease statements - such as "fiber reduces the risk of colon cancer" and "calcium prevents osteoporosis" - on food and supplement labels but only if the FDA approved and only if there was significant scientific agreement that the claim was not misleading.
And then the agency proceeded to deny almost all claims as not backed by science, argues Jonathan Emord, a Washington D.C. attorney and principle architect of the Health Freedom Protection Act.
Emord has sued the FDA on behalf of several supplement companies, including Park City-based Nutraceutical Corp. In that case, Emord persuaded U.S. District Judge Tena Campbell that the federal ban on ephedra, and amphetamine-like herb linked to dozens of deaths, was flawed. Campbell said the FDA could not stop Nutraceutical from selling low-dose ephedra products because it lacked the science to prove that daily doses of 10 milligrams or less posed an unreasonable risk of injury or illness.
The FDA, which has appealed Campbell's ruling, insists the ban remains in effect and the FDA is free to enforce it nationwide - except as to low-dose products sold by Nutraceutical. The Utah ruling, and the FDA's reaction to it, helped trigger the current legislation, Emord said.
But the real catalyst was another Emord lawsuit, Pearson v. Shalala, decided in January 1999 in the District of Columbia Circuit Court. The case involved four health claims denied by the FDA because the evidence was inconclusive: antioxidant
vitamins may reduce the risk of certain cancers; fiber may reduce the risk of colorectal cancer; Omega-3 fatty acids may reduce the risk of coronary heart disease; and .8 milligrams of folic acid in a dietary supplement is more effective in lowering the risk of neural tube defects (like spina bifida) than a lower amount in common foods.
The court ruled the FDA's disease-claim standard too broad, instructing the FDA to say what "significant scientific agreement" means or, at a minimum, what it does not mean. The court also said the FDA cannot ban a health claim because the evidence is inconclusive. Rather, the agency must permit disclaimers that describe the degree of scientific support.
"The FDA read that and went, 'Gulp,' " says Campbell, a former top official in the FDA's food safety division.
Since then there have been task forces and more lawsuits, and still the industry waits. Says Emord: "These unelected and unaccountable bureaucrats are still at their posts without so much as even a reprimand from Congress."
For its part, the FDA does not comment on legislation or litigation. But in defense of the agency, says Campbell, it has a comparatively small budget and huge responsibilities.
The FDA has taken a stab at some disclaimers, such as this recently released statement for green tea. "Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer."
But the FDA announced recently it was retooling the method for developing disclaimers. It seems the FDA's research showed that the harsher the statement, the more likely consumers are to believe the health claim. The rationale: Any company willing to acknowledge discrepancies in the science only enhances its credibility.
"It confounded the FDA," says Loren Israelsen, executive director of the Utah Natural Product Alliance, a trade group representing several Utah supplement makers.
That's why the Health Freedom Protection Act would require all health claims with some scientific support to be approved.
Israelsen, for one, worries that approach will "pop the flood gates open" and erode the industry's credibility. He for one doesn't believe the bill will pass in its current form - regardless of the FDA's current turmoil.
"They're vulnerable," he says. "But it's important for consumers to have confidence in the products they buy and there needs to be discipline and consistency in the approval of these health products. It's not nail polish we're talking about. This is very serious stuff."
The Health Freedom Protection Act would force the FDA to:
* Allow disease treatment claims for foods and dietary supplements, claims currently reserved for FDA-approved drugs.
Permit such claims unless FDA proves no scientific evidence supports the claims.
Limit FDA disclaimers on health claims to no more than three concise sentences.
Stop waiving conflicts of interest in its food advisory panels considering health claims.
Approve or disapprove health-claim petitions within 100 days or the claims will be allowed.
Allow food and supplement companies to send consumers government reports and publications on nutrient-disease associations.
Allow structure-function claims that include terms that refer to signs or symptoms of disease so long as the disease itself is not mentioned.
Reverse its denial or restriction of the following nutrient-disease association claims: (a) saw palmetto treating benign prostatic hyperplasia; (b) omega-3 fatty acids and coronary heart disease; (c) omega-3 fatty acids and sudden death heart attacks; (d) glucosamine and chondroitin sulfate treating osteoarthritis; and (e) calcium reducing the risk of bone fractures.
