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Supplement Regulation Evolves Gradually: IADSA Executive Director

IADSA, the International Alliance of Dietary/Food Supplement Associations, has hailed the progress made in developing effective food supplement regulations worldwide over the past two decades and pledged to maintain the same momentum in the coming years.

This year is IADSA’s 20th anniversary, a milestone that was celebrated at its 2018 Annual Meeting in London. Addressing attendees, IADSA Executive Director Simon Pettman said that regulation of the health supplements industry had been a “stepwise process, not a Big Bang.”

He illustrated the gradual evolution of regulation along a similar pattern across the world using examples of regional developments in ASEAN, the EU, Latin America, and the U.S., as well as global developments in Codex Alimentarius. “Codex has played a key role to help guide this process,” he told the meeting.

“All these things take time and we have a long way to go,” he said. “But in broad terms, across the world, over the past 20 years since IADSA was formed, we have always moved forward.”

Mr. Pettman said IADSA would continue to work for better integration of food supplementation in policy, harnessing partnerships with government and the scientific community. He added: “We are now at the point where we need to look more closely at where this category can fit more widely into policy. Policymakers are asking us that question and we are further investing in the information and data we need to respond.”

The meeting was attended by more than 100 representatives from IADSA’s trade association and company members, as well as regulatory bodies. During the course of the event IADSA elected a new management board to support its ongoing global program of work.

Michelle Stout, previously treasurer, was elected as chair of the IADSA board, succeeding Ric Hobby. Ms. Stout has worked in regulatory affairs for over 20 years and is currently regulatory policy director at Amway.

Steve Mister was elected to the position of vice-chair. He is president and CEO of the Council for Responsible Nutrition (CRN). IADSA’s new treasurer is Dr. Gerhard Gans, who is vice president, regulatory affairs/quality management at DSM Nutritional Products.

Ms. Stout commented: “It is an honor and privilege to be elected chair of IADSA and I look forward to continuing the excellent work of my predecessor. These are exciting times, with evidence growing of the positive impact supplements can have on people’s well-being and the well-being of society at large.”

She continued: “IADSA is committed to working with regulators and other stakeholders to ensure the global health supplements sector continues to thrive all over the world. I look forward to working alongside my fellow new board members, and the wider IADSA membership, to build on the progress we have already made in this area.”

Attendees at the annual meeting also saw the IADSA Leadership Award presented to Dr. BH Lim in recognition of his outstanding work over many years to support development of the ASEAN health supplement agreement.

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FDA Approves CBD Medicine, Signals Enforcement Priorities Against Unapproved Products

FDA on Monday announced approval of a cannabidiol (CBD)-based drug derived from marijuana, and its top official signaled where the agency will focus its enforcement priorities against companies marketing unapproved CBD products.

Epidiolex, the medicine developed by GW Pharmaceuticals plc, was approved by FDA to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients at least two years old. Many parents who have children suffering from certain forms of epilepsy have turned to CBD, but the federal government has largely considered CBD a Schedule I controlled substance, or marijuana derivative, with no acceptable medical use—until now.

Justin Gover, GW’s chief executive officer, described FDA approval of Epidiolex as “a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.”

“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine,” he said in a press release. “These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

During a conference call with reporters, Douglas Throckmorton, M.D, an FDA official, confirmed the Drug Enforcement Administration (DEA) will need to reschedule CBD into one of the schedules other than Schedule I under the Controlled Substances Act. Barbara Carreno, an DEA spokeswoman, did not immediately respond to a request for comment on the process and timing for such action, though Throckmorton said FDA wanted to get Epidiolex available to patients “as quickly as we possibly can.”

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb, M.D., said in a news release. “And, the FDA is committed to this kind of careful scientific research and drug development. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.”

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