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.
Perrigo may have advantage over patent cliff
ALLEGAN, Mich. Most people know Perrigo Co. as a leading provider of OTC medications and nutritional products, but it also has a sizeable prescription drug business. With the approach of the patent cliff, when the number of blockbuster prescription drugs losing patent protection will decline, some factors may give Perrigo an advantage.
Because Perrigo focuses its prescription drug business on topical medications, vice president for investor relations and communication Arthur Shannon said the complexity of the business insulated it from the effects of the patent cliff.
“The impending patent cliff doesn’t really apply to our business,” he said.
IMS Health vice president for industry relations Doug Long said there could be a competitive advantage for companies that market topical medications.
“I don’t think there is much difference in patent expirations, but the topical market is less competitive than oral solids,” he said. “There are more generic players in oral solids than in topicals probably because topicals are harder to make.”
Shannon also said the company’s OTC business would help it adapt.
“As we look ahead to the foreseeable future, we see good opportunities present for new product opportunities in our OTC business,” he said.
Shannon said the $25 million purchase of Diba, which will add almost $15 million to Perrigo’s annual sales, would make it the leading manufacturer of private-label medicines in Mexico, though Diba also makes prescription drugs, including antibiotics, hormonal and ophthalmic drugs. Perrigo does not plan to market its products in Mexico through Diba, or vice versa.
Nevertheless, that might not be needed.
“We are very comfortable with the future of our generic business,” Shannon said. “Being focused on topicals, we believe we are well-positioned to continue our growth.”
Olympian Michael Phelps launches PureSport athletic drinks
CHICAGO Michael Phelps, winner of eight gold medals during this year’s summer Olympics, officially launched his PureSport brand of performance beverages here on Saturday.
PureSport features an optimal carbohydrate-to-protein ratio of 2:67-to-1 that was created by University of Texas’ John Ivy. The two PureSport formulations include, PureSport Workout, which is used prior to and during exercise to improve endurance and reduce muscle tissue damage, and PureSport Recovery, which is used within 30 minutes of completing a workout to speed the storage of muscle and liver glycogen and promote muscle tissue repair.
More than 1,500 fans turned out to meet Phelps and learn more about the sports beverage that was a big part of his success, according to Phelps.
Among the athletes who have incorporated PureSport into their training regimens are world-class swimmers Michael Phelps, Brendan Hansen, Ian Crocker and Aaron Peirsol, as well as Gold medal gymnast, Nastia Liukin.