Pregnancy-Related Structure/Function Claims Could DisruptFDA's New Structure/Function Regulation

Pregnancy-Related Structure/Function Claims Could DisruptFDA's New Structure/Function Regulation
by Anthony Young

In the preamble to the Food and Drug Administration's (FDA) Jan. 6, 2000,structure/function claim regulations, FDA takes the position that claims torelieve "ordinary morning sickness associated with pregnancy" orordinary "leg edema associated with pregnancy" are not disease claims.This position evolved from the agency's determination that "conditionsassociated with a stage of life or a normal physiological process [will] beconsidered common if they occur in more than one-half of those experiencing thatstage or process."

Not unexpectedly, Dr. Sidney Wolfe of the Public Citizen Health ResearchGroup [founded by consumer activist, Ralph Nader] was on national televisionsoon after the FDA's Jan. 6 notice was released. Wolfe protested that theregulation endangers the unborn and risks a Thalidomide disaster here in theUnited States--a country that boasts it has the most advanced pharmaceuticalsafety and efficacy review system in the world. Not surprisingly, the media,which generally has a conditioned skepticism about dietary supplements, jumpedon the issue immediately. Those stories were repeated on Feb. 4 when Wolfe andformer CDCP Birth Defect Director Dr. Godfrey Oakley asked FDA to reconsiderthis aspect of its final rule and to reclassify pregnancy-related conditions asdiseases.

Ironically, no one in the dietary supplement industry proposed that FDAclassify conditions of pregnancy as common conditions of a natural state.Indeed, FDA noted at its August 1999 public meeting that no one had commentedthat toxemia of pregnancy was not a disease. And FDA takes the position thatclaims to treat benign prostatic hypertrophy (BPH), or enlarged prostate, evenif it were considered a direct consequence of aging [which the NationalInstitute of Aging says it is], are disease claims because failure to obtaineffective treatment can cause significant or permanent harm. Wolfe and Oakleytake the same position with pregnancy-related edema and morning sickness,arguing they could be precursors to serious conditions that might endanger bothmother and child. Why didn't FDA take this position with respect to pregnancy?

Who would argue with these advocates for maternal and fetal health? It isestablished that natural substances like caffeine and alcohol pose a risk to thefetus. Wolfe tells FDA in his comments that Vitamin A and ephedrine are on theFDA's risk-of-use-in-pregnancy category and that these ingredients sometimes,but not always, bear pregnancy warnings. One-third of the botanicals evaluatedin the American Herbal Products Association's (AHPA) Botanical Safety Handbookare listed as not for use in pregnancy. Even ginger, with its long history ofuse as a palliative for minor, transient upset stomach, bears pregnancy warningsas do Echinacea purpurea, ginseng, kava kava and senna. Again, why did FDA leapinto this controversial area?

When the Dietary Supplement Health and Education Act of 1994 (DSHEA) waspassed unanimously by both the Senate and the House and signed into law byPresident Clinton, FDA made only a technical resistance. At the time, FDA wasfocused on the tobacco rulemaking that has now reached the Supreme Court whereit has been argued and awaits the Court's decision. Since DSHEA was enacted, FDAhas focused its attention on issuing regulations which, as they evolve, willcover all aspects of dietary supplement production and labeling. At the sametime, however, FDA and the press have created and perpetuated the mantra thatthe dietary supplement industry is "unregulated." Their definition ofthis term, however, is not precise. What they mean is that the safety of mostdietary supplement ingredients is not reviewed by the FDA prior to marketing.This article will not debate the "regulated/unregulated" point.Suffice it to say that the dietary supplement industry has not been able toconvince the media that "unregulated" is simply wrong.

Also in the recent past, FDA has tried to reinvent itself as a science-basedhealth protection agency and, in the process, shed its prior image of food anddrug cop and national nay-saying nanny. An example of this image change occurredat FDA's August 1999 hearing on the structure/function claim proposal. FDA madea substantial effort to engage the dietary supplement industry, the governmenthealth community and specific disease and condition oriented professional groupson how to best address the common conditions of life that are not generallyrecognized as diseases. At the hearing, as well as at feedback hearings heldearlier in the San Francisco area, there was substantial discussion on the needto substantiate the safety and the effectiveness of dietary supplements. Therewas never a call for supplements to treat ordinary edema or morning sickness ofpregnancy.

So why would a science-based agency with a historical concern about maternaland fetal health [evolving from its successful blocking of Thalidomide from theU.S. market] open the door for dietary supplements to enter a sensitive marketthat no one has asked to enter? FDA may have done so to create a forum fordebate about DSHEA and where DSHEA leads--if it is read strictly or expansively.If that was FDA's intent, it may have worked. The debate is on.

Of course, any company that seeks to market a product for edema or morningsickness of pregnancy should exercise the most extreme caution--not because FDAwill closely scrutinize such products, but because our society protects mothersand infants. Insurers, courts and juries are intolerant of products formothers-to-be that have not been adequately tested for safety and effectivenessprior to marketing. Moreover, FDA reiterated in the structure/functionregulation that dietary supplement labeling must include all information that ismaterial in light of consequences that may result from use of the product orrepresentations made about it. This concept of delivering material informationto consumers has been central to our food and drug laws since 1938. The conceptdovetails with the fact that DSHEA was enacted in part to increase the amount ofinformation available to consumers regarding dietary supplements.

The controversy surrounding FDA's decision to allow dietary supplements tobear structure/function claims for the relief of ordinary edema or morningsickness of pregnancy has only begun. A conditioned industry response would beto defend the FDA's position simply because it has expanded the dietarysupplement claim base. But a more thoughtful response is required. The industryreaction to the controversy should start with the fact that FDA, not theindustry, put this issue on the table. The industry needs to carefully examinewhether it has any interest in going into a market that FDA has led it to.

Anthony Young is a partner in Piper & Marbury of Washington, D.C. andcounsel to the American Herbal Products Association.

Two days after this article was received, the FDA issued a statementasking dietary supplement manufacturers to refrain from making claims related topregnancy on their products. According to the FDA, that measure will"ensure that careful consideration is given to concerns recently raisedregarding how the structure/function rule relates to pregnancy." See storyon the cover for more information.