NBTY signs celebrity skateboarder Tony Hawk to promote vitamins
RONKONKAMA, N.Y. NBTY recently partnered with skateboarding athlete Tony Hawk on a new line of branded gummi-vitamins—the Tony Hawk HuckJam—that ought to appeal to Hawk’s half-piping fans, or boys between the ages of 8 and 16.
The chewy “gummy” vitamins, shaped like miniature skateboard decks, skateboard wheels and Tony’s signature hawk skull, provide a good source of 11 vitamins and minerals, including Vitamin C and Vitamin B-12.
NBTY has rolled out the vitamins nationally, the company reported. There are two sizes available—a 60-count bottle and a 180-count bottle. Both will contain three flavors: orange, cherry and grape.
CRN announces webinar to help guide producers through FDA ingredient regulations
WASHINGTON The Council for Responsible Nutrition and Virgo Publishing last week announced plans for a new webinar—“Bringing New Ingredients to Market: FDA Guidance and Developments in the New Dietary Ingredient Notification Process”—to be held Dec. 10.
The Food and Drug Administration’s Bill Frankos, director of the Division of Dietary Supplement Programs, is one of the featured speakers and will provide the agency’s perspective on what kind of data is required to file a successful new dietary ingredient notification, as well as offer insight into other expectations from the agency.
Frankos will be joined by regulatory experts, including George Burdock, president of the Burdock Group; Claudia Lewis-Eng, a partner at Venable; Andrew Shao, vice president, scientific and regulatory affairs, CRN; and Debbie Trinker, vice president of regulatory affairs, Kemin Health.
The webinar will provide a historical analysis of the NDI notification process since its inception by the Dietary Supplement Health and Education Act, and will include a legal review of the process as well as offering practical, actionable approaches for bringing new dietary ingredients to market.
“There are still a lot of questions surrounding this process including what steps companies should take in order to make sure they are meeting FDA’s expectations,” stated Shao. “While not everything can be answered in this two hour webinar, it is our goal to provide clarity along with substantive guidance and help companies feel they are up-to-date and well-informed about this process, particularly as we anticipate FDA will soon publish a guidance document on this topic.”
This is the third webinar produced by CRN and Virgo. The first webinar centered on the general aspects of the final good manufacturing practices rule. The second webinar focused on the specific tools for managing the supply chain and practical approaches to help address safety concerns and ensure GMP compliance.
CRN backs Bayer combination products as functional health supplements
WASHINGTON The Council for Responsible Nutrition last week spoke out against warning letters issued to Bayer Consumer Healthcare by the Food and Drug Administration regarding its dietary supplement/over-the-counter combination products Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin Plus Calcium.
“CRN continues to believe that combination dietary supplement-OTC drug products have a useful and important role to play in integrated health care and wellness,” Steve Mister, president and chief executive officer of CRN said. “Our hope is that the FDA will assist companies attempting to maneuver the regulatory challenges of developing products that combine these ingredients and meet the labeling and formulation requirements of both drugs and dietary supplements, as required by the law.”
CRN noted that the FDA in 1994 stated in the Federal Register that the “FDA does not believe that it would be appropriate to preclude such claims [health claims and OTC drug labeling] under all circumstances. Such claims may be permissible if a firm can demonstrate that dual claims can be made in a manner that will neither misbrand the product nor create a safety problem.” Since then, the FDA has issued a few warning letters addressing specific combinations of supplement and OTC drug ingredients, but has never publicly reversed its view that combination products with dual labeling can be developed that would satisfy the agency’s appropriate concerns for safety.
In its warning letters issued Oct. 28, the FDA charged that the products are unapproved new drugs requiring an approved application for the company to market them. “The FDA considers these products new drugs, and thus, they must undergo the FDA’s drug approval process,” FDA acting associate commissioner for regulatory affairs Mike Chappell said in a statement. “The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process.”