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Supplement industry responds to Senate query on alleged GMP compliance shortcomings

BY Michael Johnsen

WASHINGTON — The dietary supplement industry recently responded to a Senate query around why the dietary supplement industry is failing to live up to Food and Drug Administration regulations.

Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., contacted three dietary supplement trade associations — the Council for Responsible Nutrition, the American Herbal Products Association and the Natural Products Association — regarding a Chicago Tribune report published last month that suggested the supplement industry was falling short of operating in compliance to good manufacturing practices. "It’s downright scary," Daniel Fabricant, head of the FDA’s division of Dietary Supplement Programs, told the Chicago Tribune in the June 30 report. "At least half of industry is failing on its face."

"An article published in the Chicago Tribune … reports that in the last four years, the Food and Drug Administration found violations of manufacturing rules in half of the nearly 450 dietary supplement firms it inspected," the senators wrote in a letter to the NPA. "Further, 1-out-of-4 dietary supplement companies inspected by FDA received a warning letter. … To ensure consumer safety, we are eager to hear of the industry’s plans for improving the successful adoption of cGMPs by companies that manufacture, package, label and distribute dietary supplements marketed in the United States."

In a letter addressing Blumenthal, NPA executive director and CEO John Shaw wrote, "NPA believes the FDA’s reckless comments in the Chicago Tribune article distort the full picture of our membership’s overall safety record. In fact, supplements have an excellent safety record, but we appreciate this opportunity to provide more information to you."

"Consumers deserve to know that, without question, their dietary supplement products are safe and made to high quality standards," commented Steve Mister, CRN president and CEO, in a separate letter to Durbin. "We will continue to support FDA in its efforts to assure compliance with the cGMPs; however, the information apparently reported by [the] FDA should also be kept in context."

CRN cautioned the senators against making premature conclusions solely based on the FDA’s report that 1-in-4 dietary supplement companies warranted a warning letter following an inspection. The FDA concentrates its enforcement efforts on companies already suspected of being in violation of cGMPs, Mister suggested. "The firms [the FDA] selects for inspections are not a random sampling of the entire supplement industry, nor are they representative of the many firms in full compliance with the GMP requirements."

In response to Fabricant’s quote that "half of industry is failing on its face," Mister responded: "The statistics the agency recently presented to industry do not bear out that statement. Based on [the] FDA data shared with the industry in June, a statement, such as, ‘at least half of those inspected (as opposed to the industry in general) produced a notation for some form of follow-up action’ would be accurate only if one were to include a category of notations for ‘voluntary action indicated.’"

VAIs, Mister noted, are minor violations that are oftentimes corrected on the spot and do no warrant subsequent regulatory action.

“We were surprised about the commentary given by the FDA to the Chicago Tribune last week, especially considering our strong ongoing relationship with the FDA to address related concerns," Shaw stated. "We look forward to working with our friends in Congress and the administration to further educate them about the multiple benefits [dietary supplement manufacturers] provide to millions of American consumers.”

For the original Chicago Tribune story (free registration required), click here.

For the letter from Sens. Durbin and Blumenthal to the NPA, click here.

For CRN’s response letter, click here.

For NPA’s response letter, click here.


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Belcastro heads to Hillshire Brands

BY Allison Cerra

DOWNERS GROVE, Ill. — A Grocery Manufacturers Association executive is taking on a new role at Hillshire Brands.

Dennis Belcastro has been named VP government and industry affairs for Hillshire Brands and will be responsible for developing and implementing the company’s engagement strategy with federal, state and local elected officials, regulatory agencies and key policy-makers, in addition to managing strategic customer and industry events. Belcastro officially steps into his new role on July 30.

Most recently, Belcastro was EVP industry affairs and collaboration at the Grocery Manufacturers Association. At GMA, he led the Industry Affairs Council, one of three key industry guidance and governance committees that represent more than 300 leading food, beverage and consumer product companies.

"Denny’s ability to facilitate relationships with all levels of government and across the industry will help Hillshire Brands navigate and respond to the regulatory environment that surrounds modern food production," Hillshire Brands CEO Sean Connolly said. "We are pleased to have him bring his knowledge of the industry and food business acumen to Hillshire Brands."

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FDA approves generic emergency contraceptive

BY Alaric DeArment

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the drug maker said Friday.

Watson announced the approval of Next Choice One Dose (levonorgestrel) tablets in the 1.5-mg strength. The drug is an emergency contraceptive used to prevent pregnancy following unprotected sex or contraceptive failure.

The drug is a generic version of Teva Women’s Health’s Plan B One-Step, which had sales of about $88 million during the 12-month period ended in March, according to IMS Health.


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