HEALTH

Dietary supplement legislation receives support from CRN, NPA

BY Michael Johnsen

WASHINGTON Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah, on Tuesday introduced the Dietary Supplement Full Implementation and Enforcement Act of 2010, a piece of legislation designed to provide the Food and Drug Administration with additional enforcement resources.

Each of the leading trade associations representing the supplement industry issued their support behind the bill.

“[The Council for Responsible Nutrition] applauds Sens. Tom Harkin and Orrin Hatch for their efforts to fully fund, implement and enforce the Dietary Supplement Health and Education Act of 1994,” stated Steve Mister, CRN president and CEO. “CRN and its member companies have long advocated for more resources to help the FDA better enforce industry regulation, and this bill is a step in the right direction to making that happen.”

John Gay, executive director and CEO of the Natural Products Association added, “While some have called for additional regulations on supplements, Sens. Harkin and Hatch understand that the real need is to fully enforce the stringent statutes already on the books, to the full extent of the law. The way to get the bad actors out of the industry is by putting more cops on the street, plain and simple.”

This legislation reinforces the authority FDA has to regulate the supplement industry under DSHEA, and ensures the agency has additional resources to more fully implement that authority. The bill would provide FDA with additional resources over a five-year period to accomplish important regulatory mandates set out by DSHEA, including:

  • Assuring that manufacturing facilities are GMP compliant through additional facility inspections;
  • Calling on FDA to issue clear guidance for new dietary ingredients and the submission of these NDI notifications, as well as the criteria for establishing a reasonable expectation of safety for these ingredients;
  • Implementing an annual registration process for supplement manufacturers, packers and distributors;
  • Requiring more dialogue between FDA and the Drug Enforcement Administration so that anabolic steroids or their analogues do not reach consumers as a mislabeled supplement; and
  • Developing appropriate consumer education initiatives that will create more informed supplement customers.

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Pharmavite names CEO

BY Michael Johnsen

NORTHRIDGE, Calif. Pharmavite on Tuesday named Doug MacLean as the company’s new CEO.

MacLean comes to Pharmavite from TalkingRain, a Seattle-based beverage company focused on health-conscious consumers, providing natural waters and functional beverages, where he most recently served as CEO.  During his tenure, he led the organization from a start-up to a successful, independent beverage company.

At Pharmavite, McLean’s strategic priorities will include accelerating the growth of new products in the United States in conjunction with Pharmavite’s parent company, Otsuka Pharmaceutical Corporation, and maintaining a continued focus on the financial health and effectiveness of Pharmavite’s overall business.

MacLean officially will join Pharmavite June 1.

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Sen. Harkin poses questions for FDA following cough-cold medicine recall

BY Michael Johnsen

WASHINGTON Sen. Tom Harkin, D-Iowa, on Monday penned a letter addressing Food and Drug Administration commissioner Margaret Hamburg following the recall of 40 varieties of children’s and infants’ formulations of Tylenol, Motrin, Zyrtec and Benadryl by Johnson & Johnson’s McNeil Consumer Healthcare.

“I commend you for FDA’s leadership in responding to this crisis, both in terms of your outreach to the public and your increased regulatory activity,” Harkin wrote.  “However, I am interested in ensuring that, as a public health agency whose mission is to protect the American public, you have sufficient authority to prevent and respond to contamination of the drug supply. I am especially concerned because so many of the drugs at issue in this recall were intended for infants and children.”

Harkin, who is chairman of the Senate health, education, labor and pensions committee that has jurisdiction over the FDA, posed questions regarding the recall, events leading up to it and consumer complaints.

Harkin was particularly interested in the voluntary recall process, asking if the FDA had initiated the request for a voluntary recall, and had they been denied that request, would the agency have had the authority to mandate a recall.

Harkin requested FDA respond to his list of questions by June 11.

For a full copy of the letter, click here.

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