US Pharm. 2006;1:26.

Marketers of Bogus Avian Flu Therapies Reprimanded
FDA has issued warning letters to nine companies marketing products with claims of effectively preventing avian influenza or other flu strains. The agency did not find evidence of safety or efficacy of these products and expressed concern that the therapies could harm consumers or interfere with conventional treatments.

Of the nine companies that received FDA warning letters, eight marketed dietary supplements with claims of preventing, killing, treating, or shielding against avian flu. The companies also stated that their products were natural or safer than approved treatments or preventive medical products.

In its warning letters, FDA stated that the firms needed FDA approval for their products before marketing them, as the agency considered the products drugs due to the manufacturers' claims.



Barley Products Can Carry Health Claim
Whole-grain barley and barley-containing products can carry claims that they reduce the risk of coronary heart disease (CHD), according to a recent FDA announcement.

The health claim may appear on whole-barley and dry milled barley products such as flakes, grits, flour, and barley meal. An example of the claim is "Soluble fiber from foods such as [name of food], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies [x ] grams of the soluble fiber necessary per day to have this effect."

Food manufacturers may immediately use the health claim regarding barley and the reduced risk of CHD through the issuance of an interim final rule. To qualify for the claim, barley-containing foods must provide at least 0.75 g of soluble fiber per serving.

Condom Guidance Issued
New recommendations for labeling of latex male condoms are available in draft guidance prepared by FDA's Center for Devices and Radiological Health. The recommendations are not binding unless they are published as a final rule.

Regarding the risk of unintended pregnancy associated with condom use, FDA proposes that manufacturers specify on condom packaging that condoms reduce--but do not eliminate--the risk of pregnancy and include a table comparing pregnancy rates associated with barrier contraceptives. FDA urges the inclusion of statements on risks of transmission of HIV/AIDS and other sexually transmitted diseases (STD) associated with condoms.

FDA also proposed labeling for condoms with lubricant containing nonoxynol-9 (N-9). Although N-9 kills sperm, the agency does not know the extent of pregnancy protection contributed by the spermicide. Furthermore, FDA advises condom manufacturers to include labeling stating that N-9 does not protect against HIV/AIDS or other STDs and that it can irritate the vagina or anus, leading to increased risk of HIV/AIDS.

--Abigail Brugger

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