Supplement Labeling Toll-Free AER Number Provision Included In House Bill

Ephedrine alkaloid-containing dietary supplements would be prohibited from sale to people under 18 and limited to "behind-the-counter" distribution under a bill introduced by freshman Rep. Susan Davis (D-Calif.) Oct. 9.

The "Ephedra Alkaloid Consumer Protection Act" (HR 3066) also would require ephedra products to carry a warning detailing contraindications and risks, cautioning against taking ephedra with caffeine or other stimulants, listing the amount of "ephedrine group alkaloids per serving" and citing a toll-free number and Web site address where consumers could report adverse events to FDA.

The bill would apply to "all prerecorded or scripted radio or television advertising," and would require that they include the notice: "This product contains ephedrine group alkaloids and may cause serious adverse health effects. Read the label and follow directions."

HR 3066 follows earlier efforts by Davis to pass similar legislation on the state level. In February 2000, while in the California Assembly, she introduced AB 2294, which would have banned the sale of ephedra products not carrying a warning like the one in HR 3066. The measure was vetoed by Gov. Gray Davis (D) last September (¹ (Also see "California Ephedrine Alkaloid Supplement Labeling Bill Veto Unexpected" - Pink Sheet, 9 Oct, 2000.)).

Another bill introduced by Davis on Oct. 9 would make reporting of dietary supplement adverse events to FDA mandatory.

Under the "Dietary Supplement Information Act" (HR 3065), any supplement manufacturer, packer or distributor would have to notify FDA of "any information received on serious adverse experiences regarding the supplement...in no case later than 15 calendar days after the initial receipt of the information."

Written procedures regarding the handling of such information, "including procedures for surveillance, receipt and evaluation of information on such experiences," would have to be established by supplement firms as well.

FDA would be responsible for creating a system to receive, store and retrieve the AERs, "and carry out such other administrative functions" as necessary, according to the bill. FDA currently operates the Special Nutritionals Adverse Event Monitoring System, which has been widely criticized for its lack of effectiveness.

In terms of AER follow-up, the involved dietary supplement firm would be required to investigate the experience and submit its findings - as well as its investigation protocol - to FDA, which would then "conduct a clinical evaluation."

If FDA determines a supplement's use or expected use poses a "reasonable risk" of serious adverse events, the bill would permit the agency to order a period of post-marketing surveillance of up to 36 months.

"Serious" is defined in the bill as an event that results in death, hospitalization, "a persistent or significant disability or incapacity, or a congenital anomaly, birth defect or other effect regarding pregnancy." Reports of adverse events deemed nonserious would be required on an annual basis.

Owners and operators of supplement manufacturing, packaging, distributing or importing firms also would have to annually register their names, the names of their establishments and their places of business with FDA, as well as provide the agency with labeling for all the firms' dietary supplements.

Davis' office said there are no plans to hold a hearing until next session. Although no companion legislation has been drafted, recruitment of cosponsors for the House bill has begun.

The Consumer Healthcare Products Association and Council for Responsible Nutrition expressed doubts as to the usefulness of either bill, saying the Dietary Supplement Health & Education Act is sufficient. FDA release of supplement GMPs, improvement of its AER system and creation of uniform warning labels for ephedra products "would render these legislative proposals unnecessary," CRN said.

FDA's FY 2002 budget requests $1 mil. for its AER system; the agency has been denied previous requests of $2.5 mil. (² (Also see "Public Outreach To Consumers, Physicians Could Improve AE Reporting - OIG" - Pink Sheet, 23 Apr, 2001.)).

However, nine consumer advocate and research organizations, including the American Cancer Society, American Heart Association and Center for Science in the Public Interest, called the Davis bills "an important first step towards evaluating the safety of dietary supplements on the market" in an Oct. 9 letter.