Supplement/Disease Claim Continuum Suggested By CHPA

FDA acceptance of disease-treatment health claims and subsequent revision of the term "nutritive value" to reflect a dietary supplement ingredient's ability to restore normal/proper function is urged by the Consumer Healthcare Products Association.

"Diet/disease treatment relationships can be a logical health-based extension of dietary supplement function," CHPA says in written comments. Under the January 1999 D.C. federal appeals court ruling in Pearson v. Shalala, truthful claims are allowable, thus "it would be sound policy to amend the health claim regulations to permit such claims," CHPA maintains.

"FDA should redefine nutritive value, so as to recognize that the processes by which a dietary constituent promotes health, maintains proper bodily functioning, protects the body from the development of chronic disease or other health related conditions, and facilitates and/or restores healthy functioning are, in and of themselves, characteristic of 'nutritive value,' thereby creating a more logically flexible approach to health claims," the association suggests.

The question of whether health claims for dietary supplements should go beyond prevention of disease to include claims about treatment or mitigation was posed by FDA during one of three panel discussions held at an April 4 public meeting to discuss the results and implications of the Pearson decision.

Speaking at the meeting, CHPA Senior VP and Director of Science & Technology William Soller, PhD, suggested FDA establish specific criteria to define a "disease treatment-related health claim," whereby factors such as safety information on an ingredient-disease relationship and necessary labeling content could be provided by the agency.

Soller called for a "continuum of claims," whereby the "truthfulness of the claim, as opposed to the validity of the relationship," is taken into account. CHPA favored such an approach in recent comments on FDA's "significant scientific agreement" guidance (¹ (Also see "SSA Standard Should Focus On Claim Truthfulness, CHPA Says" - Pink Sheet, 13 Mar, 2000.)).

Specifically, Soller characterized different supplements as having varying degrees of effectiveness and varying risk profiles. For example, he noted, using calcium to support the healing of fractured bones would raise little question regarding safety and efficacy.

A supplement/disease claim in the middle of the spectrum may be a product such as red yeast rice, he added, which could augment therapy for high cholesterol, while at the far end could be the use of St. John's wort for "severe depression," which could present a specific risk to certain populations.

A "range" of claims appropriate for each class of nutrient/disease relationships along the continuum could be developed, Soller asserted, "keeping in mind there should not be an unreasonable risk" associated with any product used to treat disease.

Center for Drug Evaluation & Research Office of Medical Policy Deputy Director Rachel Behrman, MD, asked how one could communicate to the consumer the differing effectiveness and standards for drugs and dietary supplements. "I think if you thought it was important from a safety standpoint...[to] communicate that, you might put it into a qualifier," Soller replied.

Providing a different perspective on the issue, American Urological Association Health Policy Council Chair Logan Holtgrewe, MD, opined that supplements "should be under the control of FDA just as are other pharmacological products advocated and marketed to treat disease. If you are treating disease, it should be a level playing field."

Holtgrewe stressed the need for more research on supplements, focusing primarily on the use of saw palmetto in treating lower urinary tract ailments and benign prostatic hyperplasia (BPH).

The researcher warned of the "irreparable harm" older men may be inflicting on themselves by using saw palmetto as a treatment for lower urinary tract conditions. He characterized prostate and bladder ailments as "always" arising from disease, and noted the use of saw palmetto might mask serious health problems.

"If you're going to have a disclaimer on products marketed to treat lower urinary tract symptoms, there should be in big bold letters 'You may have cancer, and it may kill you.' But anything short of that I think is inadequate," the researcher maintained, calling for properly controlled, randomized clinical trials showing efficacy and safety of supplements.

A Phase IIb study on saw palmetto and BPH from ingredient maker PharmaPrint was completed last year with positive results. The National Institute on Aging and National Institute of Diabetes & Digestive & Kidney Diseases, along with the National Center for Complementary & Alternative Medicine, are sponsoring a similar study.