FDA seizes ephedrine ingredients
SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. marshals on Tuesday seized raw materials imported by Infinity Marketing Group containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics that have been banned by the FDA for use in dietary supplements since 2004.
The seizure took place in Rancho Dominguez, Calif. Through this action, FDA removed more than $70,000 worth of dietary supplement ingredients from the market.
"Working in close coordination with our federal colleagues in U.S. Customs and Border Protection, Immigration and Customs Enforcement and the Drug Enforcement Administration, the FDA helped identify and remove these potentially dangerous products from the marketplace," said Dara Corrigan, FDA associate commissioner for regulatory affairs. "We will continue to take enforcement action that prevents potentially harmful products from reaching consumers and endangering their health."
Ephedrine alkaloids are adrenaline-like stimulants that potentially can have dangerous effects on the heart. Prior to 2004, dietary supplements containing ephedrine alkaloids extensively had been promoted for aiding weight control and boosting sports performance and energy. But available data showed little evidence of the compound’s effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raised blood pressure and otherwise stressed the circulatory system. These effects were linked to significant adverse health outcomes, including heart attack, stroke and death.
FDA’s chemical analysis confirmed the presence of these alkaloids in the shipment, but the shipping drums carried no labels indicating that the material contained the banned ephedrine alkaloids.
Dietary supplement industry bands together to challenge NDI reporting requirements
WASHINGTON — Five trade associations representing the dietary supplement industry on Tuesday collectively called for an overhaul of the Food and Drug Administration’s draft guidance regarding new dietary ingredient reporting requirements.
"The [NDI] draft guidance issued by FDA in July, if implemented and enforced by FDA, would burden industry, placing unreasonable requirements on business, especially smaller firms, and create unreasonable barriers of entry for newer market entrants, without any related benefits for consumers," the trade associations stated. While the groups submitted separate comments to reflect their own membership priorities, the five associations stressed that FDA should focus on the common themes in their respective submissions. “We are all committed to seeing a substantial overhaul of the draft guidance and are united in our common belief that the document is overreaching and contravenes [the Dietary Supplement Health and Education Act]."
Common key issues include:
Requiring submission of a notification for virtually every product that contains an NDI from every manufacturer;
A shift in the burden of proof that an ingredient is not an NDI from the FDA to individual companies;
FDA’s claim that there are no authoritative lists of “grandfathered” ingredients that can be used to establish that a dietary ingredient is an Old Dietary Ingredient, which dismisses the relevance of “grandfathered” lists submitted by the trade associations in 1996-1998 for establishing that dietary ingredients are pre-DSHEA ingredients;
Redefining the meaning of the term ‘‘chemically altered’’ in such a way that significantly expands the category of ingredients that would constitute an NDI;
Stating that human synthesized constituents of botanical ingredients are different from those synthesized by the plant; and
Imposing a level of data necessary to demonstrate the safety of an NDI similar to what is required for food additives, a standard already rejected by Congress and the courts.
The trade associations include the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance.
BodyArmor SuperDrink earns BevNet award
SANTA MONICA, Calif. — BodyArmor SuperDrink was named "best functional drink" at the 9th Annual Best of BevNet 2011 Awards ceremony, which was held during the BevNet Live 2011 Winter Conference this week.
Launched in May, the BodyArmor SuperDrink product line includes four flavors and two teas. Each flavor features proprietary SuperBlends — consisting of polyphenols, vitamins A, C, B complex, electrolytes and amino acids — along with coconut water fortified with additional electrolytes.
"BevNet’s recognition of our efforts in such an exciting and competitive time in the beverage industry is an amazing honor, and I’m both thankful and invigorated to be receiving this award from the BevNet community," company founder and CEO Lance Collins said. "The functionality of BodyArmor SuperDrink is core to our mission and with this award, we renew our commitment to putting the full force of our people and resources to drive innovation and multifunctionality in all our products."