Herbals making therapeutic claims should be Rx or OTC drugs, CSPI tells commission.

HERBALS MAKING THERAPEUTIC CLAIMS SHOULD BE Rx OR OTC DRUGS, CSPI suggests in Aug. 4 comments responding to the President's Commission on Dietary Supplement Labels draft report on dietary supplement labeling, claims and safety. "We urge the commission to recommend that the FDA categorize herbal products making therapeutic claims as either prescription or over-the-counter drugs, depending upon whether such products can be used safely without medical supervision," the Center for Science in the Public Interest says. The draft report was issued June 4 ("The Tan Sheet" June 30, pp. 17-25). CSPI is a non-profit consumer group with 1 mil. members.

"We are pleased that the commission has recognized that many herbal supplements are being sold as alternatives to drugs and should be regulated as drugs," CSPI says. "While we agree that an OTC review of herbal products is appropriate, we believe it should also be made clear that some herbal products may be safe only when they are available by prescription use. For example," the consumer advocacy group argues, "it is well-known that many of the most widely used prescription drugs are of botanical origin -- the heart drug digitalis comes from foxglove, codeine comes from the opium poppy, the cancer drug taxol comes from the bark of the yew tree."

"Thus, botanic origin alone should not determine whether a product is regulated merely as an OTC drug," CSPI states. "The conditions for which the product is being used, the potential adverse effects associated with the use of the product, and the risks associated with using a particular product when another conventional treatment is available are all factors that should be considered when deciding whether to treat a botanical product as a prescription or an OTC drug." The group suggests that the commission final report recommend that "botanicals used to treat serious conditions, such as heart problems, or those that pose serious risks for misuse, should only be available for use under medical supervision."

The commission should urge FDA to "take the lead" in forming the expert advisory panels recommended in the report to establish significant scientific agreement for health claims and to review safety and labeling, CSPI suggests, adding that the cost of the advisory panels should be offset by user fees from dietary supplement manufacturers and retailers.

CSPI argues against the use of industry-sponsored panels and third-party authorities to review safety and labeling matters. "These functions are the responsibility of the FDA and must not be delegated to private parties who may hold a vested interest in the outcome of such proceedings," CSPI states. "Dietary supplement trade associations, foundations and institutes are particularly inappropriate organizations to conduct such work."

Health claims for supplements should meet the same scientific standards as those for conventional foods, CSPI agrees. However, the group is worried the commission "may be unintentionally weakening this policy" with its recommendation that "the standard of scientific agreement should not be so strictly interpreted as to require unanimous or near-unanimous support....Although the legislative history of the provision requiring `significant scientific approval' specifically states that unanimity is not required," CSPI notes, "it also specifies that `the standard is intended to be a strong one.'"

"FDA needs to provide more guidance on the differences between structure/function claims and health claims," CSPI declares. "We support the commission's attempt to provide guidance on what constitutes a permissible structure/function claim and how such claims can be distinguished from health claims or drug claims," the group says.

CSPI suggests that, upon receipt of structure/function claim notifications required by the Dietary Supplement Health & Education Act, FDA should issue acknowledgment letters to manufacturers stating whether their claims are appropriate. FDA did send notification letters when companies first began filing claims but quickly decided to stop due to the large volume of claims and limited agency resources.

The commission also should urge FDA to develop more specific guidelines outlining the amount and quality of scientific evidence necessary to back up structure/function claims, CSPI states. The group takes issue with the proposed consumer substantiation summaries, noting that if they are released to consumers before FDA has reviewed them, "the potential exists for manufacturers to provide consumers with summaries of `substantiation' for claims that should not have been made in the first place."