Content about Regulatory and Washington

SILVER SPRING, Md. — Due to the public concern related to the nuclear incident in Japan, there has been an increased demand for such drugs as potassium iodide (KI), used to prevent and treat the harmful effects of radiation, according to a Food and Drug Administration Web page updated Thursday.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Thursday recommended that Peak Life modify its advertising to clearly convey the message that claimed sleep benefits associated with its Somnapure dietary supplement are achieved from a regular, consistent program of supplementation with these ingredients, and not with one-time use.

WASHINGTON — Menthol-flavored cigarettes are the latest target for tobacco opponents, according to published reports.

Reuters reported Friday that a committee of advisers to the Food and Drug Administration said in a report that banning mentholated cigarettes would benefit public health. Under legislation adopted in 2009, most flavored cigarettes already are banned.

NEW YORK — Drug makers Gilead Sciences and Roche are suing Indian drug maker Natco Pharma concerning a generic version of an influenza treatment, according to published reports.

Bloomberg reported that Gilead and Roche were accusing Natco of patent infringement due to its efforts to gain approval from the Food and Drug Administration for a generic version of Tamiflu (oseltamivir phosphate). Natco became the first company to file for approval of a generic version in February.

WASHINGTON — The Natural Products Association on Wednesday outlined five key industry issues for the U.S. Department of Commerce and the Office of the United States Trade Representative for the U.S.-China Joint Commission on Commerce and Trade.

The NPA focused on removing barriers for trade to China with recommendations on increasing transparency, clarifying and reforming regulations, and enhancing export opportunities.

NEW YORK — Pfizer is recalling a painkiller drug it acquired when it bought King Pharmaceuticals due to problems with a chemical used to deter drug abuse, according to a published report.

Reuters reported that Pfizer had recalled supplies of Embeda (morphine sulfate and naltrexone hydrochloride) because the chemical that prevents the drug from being ground up or dissolved by drug abusers — naltrexone — had deteriorated in samples of the drug that Pfizer had tested.

The drug has sales of less than $70 million per year, according to Reuters.

WASHINGTON — The National Retail Federation said legislation introduced Tuesday to delay swipe fee reform, which is scheduled to go into effect this summer, would block retailers from giving discounts to consumers who use debit cards and would cost merchants and the public more than $1 billion per month.

WASHINGTON — Atico International USA issued a voluntary recall of 57,000 holiday rattle baby slippers amid a choking hazard, according to the Consumer Product Safety Commission.

The CPSC reported that the soft shoes with built-in rattles were imported from China by Atico International USA of Fort Lauderdale, Fla., and sold nationwide at Walgreens stores from October 2010 through January 2011 for about $5.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday outlined a new campaign attacking fraudulent weight-loss products marketed as dietary supplements, especially those companies that proffer a “magic pill” that almost immediately achieves weight loss.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Monday referred advertising for the dietary supplement Trigosamine Fast Acting (Trigo FA) to the Federal Trade Commission for further review following Patent Health’s failure to modify claims.

NEW YORK — "Fake drugs are a big threat and an exploding threat," Kumar Kibble, deputy director of Immigration and Customs Enforcement, told the news program "60 Minutes" in a segment that appeared Sunday night.

FORT WASHINGTON, Pa. — McNeil last week finalized the terms of a consent decree of permanent injunction with the Food and Drug Administration for manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, Puerto Rico; Fort Washington, Pa.; and Lancaster, Pa.

The consent decree is subject to approval by the U.S. District Court for the Eastern District of Pennsylvania.