November 20, 2013

Through mid-November, a national registry of over-the-counter drugs considered chemical precursors to methamphetamine prevented more than 16,700 boxes of the drugs from being sold illegally.

November 19, 2013

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, the agency announced Monday.

“This company has a responsibility to ensure its products are safe for distribution and human consumption,” stated Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system.”

The retail value of the seized products is more than $2 million, the agency estimated.

A complaint filed in the U.S. District Court for the Northern District of Georgia alleged that the products were adulterated according to the Federal Food, Drug, and Cosmetic Act because they contain DMAA, an unapproved food additive that is deemed unsafe under the law.

The FDA is urging consumers not to buy or use supplements containing DMAA, which can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine. Consumers should check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The FDA has warned consumers about the health risks of DMAA on its web site.

On Nov. 12, 2013, U.S. Marshals seized more than 1,500 cases of finished goods and more than 1,200 pounds of in-process/raw material goods from the Hi-Tech Pharmaceuticals facility.

During the FDA’s inspection of Hi-Tech Pharmaceuticals, which began in October, investigators identified 11 products that were labeled as containing DMAA or its chemical equivalent. These products included Black Widow, ECA Xtreme, Fastin, Fastin-XR, Lipodrene, Lipodrene Hardcore, Lipodrene XR, Lipodrene Xtreme, Lipotherm, Stimerex-ES, and Yellow Scorpion. The investigators also observed bulk DMAA raw ingredients at the facility. Prior to the seizure, on Nov. 1, 2013, the FDA issued an administrative detention, temporarily holding the products until they were seized.

Dietary supplements containing DMAA are illegal and the FDA is using all available tools at its disposal to remove these products from the market. In 2012, the FDA issued warning letters to companies notifying them that products containing DMAA need to be taken off the market or reformulated to remove this substance.

November 19, 2013

A pair of Congress leaders — Reps. Doug Collins, R-Ga., and Martha Roby, R-Ala. — on Tuesday advocated for community pharmacy with letters addressed to the leaders of the House Energy and Commerce Committee and Ways and Means Committee.

November 18, 2013

Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

November 18, 2013

The Consumer Healthcare Products Association on Friday submitted a letter to U.S. Treasury Secretary Jacob Lew, thanking the Administration for its recent efforts to enhance flexible savings arrangements’ benefits, the association announced.

November 18, 2013

The Environmental Protection Agency has recognized Ahold USA for its efforts to reduce food waste, the agency said.

November 18, 2013

URAC has granted accreditation to Parkway Pharmacy, a specialty pharmacy based in New Jersey.

November 18, 2013

A bill that would implement federal tracking and tracing of drugs and strengthen federal regulations on pharmacy compounding has passed in the Senate and will go to President Barack Obama for his signature.

November 15, 2013

A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

November 15, 2013

The Food and Drug Administration has approved a new drug for fungal infections of the skin made by Valeant Pharmaceuticals International, the drug maker said Friday.

November 15, 2013

The Food and Drug Administration has approved an OTC personal lubricant that helps couples conceive more easily.

November 15, 2013

The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

November 15, 2013

The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.

November 15, 2013

New cardiovascular health guidelines released this week could dampen the potential popularity of an up-and-coming class of cholesterol drugs, according to published reports.

November 14, 2013

The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert.

November 14, 2013

New legislation signed into law Wednesday encourages states to adopt laws allowing schools to maintain a supply of emergency treatments for life-threatening allergy attacks.

November 14, 2013

Domestic violence has devastating effects on families, but new research also links it to chronic disease in women and calls on healthcare professionals to do more to determine whether there may be a link between the two in patients.

November 13, 2013

As cold and flu season kicks into high gear, the Acetaminophen Awareness Coalition on Tuesday issued a nationwide safety message urging consumers to double-check their medicine labels so they don’t double-up on medicines that contain acetaminophen when treating winter illnesses.

November 13, 2013

The Food and Drug Administration has approved a new drug for treating a rare and aggressive type of blood cancer, the agency said Wednesday.

November 13, 2013

The Food and Drug Administration has given special designation to a drug under development by Mast Therapeutics for a rare disease that restricts the flow of blood to the limbs.

November 13, 2013

Greater use of statins in reducing the risk of high cholesterol is among the long-awaited new guidelines for treating lipid and weight disorders.

November 13, 2013

The chairman of the Senate Health, Education, Labor and Pensions Committee highlighted the human tragedy wrought by last year's fungal meningitis outbreak linked to contaminated injectable steroids as he spoke in favor of a new law that would regulate compounding pharmacies and also implement federal track-and-trace policies for drugs during a recent speech.

November 12, 2013

According to an article published in Annals of Internal Medicine Monday, a systematic review of published studies found insufficient evidence that vitamin and mineral supplements are effective for preventing cardiovascular disease, cancer or mortality from those diseases in healthy adults.

November 11, 2013

Customers of Amazon living in New York and Los Angeles can get their packages delivered on Sundays, courtesy of the U.S. Postal Service.