Boiron Anthrax Disclaimer Added To Homeopathic Product Packaging

Boiron USA has added a disclaimer to the packaging of its Anthracinum homeopathic remedy notifying consumers the product is not intended to treat or prevent anthrax.

The disclaimer states Anthracinum "is labeled for relief of symptoms of acne and boils. Please note that the literature does not support, nor is the product labeled for, use as either prevention of or treatment of infections caused by anthrax. If you believe that you... [have] Bacillus anthracis, please see a licensed health care provider immediately."

Newtown Square, Penn.-based Boiron began shipping the product with a disclaimer in mid-October, after noticing a significant increase in sales coinciding with the national anthrax scare. Sales have begun to return to normal levels since the disclaimer was added, the company said.

The product name, which could still cause consumer confusion, refers to the fact it contains inactivated Bacillus anthracis. Boiron noted "the strain is deactivated prior to use in manufacturing...and presents no risk to patients."

Trade groups representing the homeopathic industry issued a statement Nov. 1 notifying consumers their products should not be taken for the prevention or treatment of anthrax.

"There is no homeopathic literature nor clinical trials which support any homeopathic drug and more specifically Anthracinum for use as either prophylaxis for or treatment of, infections caused by anthrax," the statement reads.

"Web sites and marketers selling homeopathic medicines as OTC products for epidemic and infectious diseases may be in violation of Federal laws," the trade groups continue.

The statement was developed by the American Association of Homeopathic Pharmacists in conjunction with the American Institute of Homeopathy, the National Center for Homeopathy and the Homeopathic Pharmacopoeia of the United States.

The warnings follow a joint statement recently released by the American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition, National Nutritional Foods Association and Utah Natural Products Alliance that notes the associations "strongly believe there are no dietary supplements that have been proven to treat or prevent anthrax."

The dietary supplement trade groups' position was further emphasized in 40 email warnings the Federal Trade Commission sent Nov. 19 to Web sites promoting products intended to "prevent, treat or cure anthrax, smallpox, and other health hazards."

Although the warnings were sent to only 40 sites, FTC said it has uncovered over 200. The "additional sites are being evaluated for possible warning letters," the commission added.

Recipients of the letters have been given seven days to remove the fraudulent claims from their Web sites or risk legal action by FTC, the warnings note. Factors determining what action the commission will take include the claims' aggressiveness, the possibility of settlement and the size of the company, FTC said.

Continued violations of the FTC Act could result in "a federal district court injunction...or an administrative cease and desist order, enforceable through civil penalties of up to $11,000 per violation. Sellers could also be ordered to make consumer refunds," the commission warns.

The letters are part of an initiative undertaken by FTC, FDA, 30 state Attorneys General and the California Department of Health Services, among other organizations (¹ (Also see "FDA, FTC, 30 State AGs Join Forces To Combat Fraudulent Anthrax Products" - Pink Sheet, 5 Nov, 2001.), p. 3).

The products being sold on the targeted Web sites include dietary supplements and homeopathic remedies, as well as gas masks and protective suits.

FTC's email warning notes the agency is "aware of no scientific basis for...claims" supplements are "effective in the treatment or cure of anthrax, smallpox, or another disease or health hazard that may be associated with recent reports about threats of terrorism."

The help ensure the Web sites comply and remove the unsubstantiated claims, the email warnings also note "FTC investigators have copied and preserved the pages of your online promotional materials and will be revisiting your Web site soon."

The warnings conclude by stating, "without competent and reliable scientific evidence to substantiate these claims, the claims are illegal...and must be discontinued immediately."