The U.S. FDA signaled strengthening of regulation of dietary supplements in remarks by FDA Commissioner Scott Gottlieb, M.D. He notes “…In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.”
FDA “sent out 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases.”
To some of us, the promotion of nutritional supplements by some firms goes beyond that allowed by law. Further, some firms prey upon patients’ unfounded belief that “If it’s natural, it must be safe”.
In a recent editorial in EyeNet on the importance of collaboration in successful research, past-president of the American Academy of Ophthalmology, Ruth Williams, M.D. cites Dr. Novack. Dr. Novack stated “…You cannot be successful unless you realize that you do NOT know everything”. Further she states that “…major breakthroughs usually require a multi-disciplinary approach, ophthalmic researcher must recognize and woo individuals who may not currently be working on vision research”. A prime example of this is the Glaucoma Research Foundation’s “Catalyst for a Cure”.
Please see the first issue of OIS Press with updates on novel ophthalmic therapies. I provide a perspective in recent US FDA approvals (Pages 9 and 11).
Gary D. Novack, Ph.D., was selected to be a fellow of the American College of Clinical Pharmacology (ACCP). ACCP consists of a full spectrum of clinical pharmacology professionals from academia, industry, government and clinical settings who span the scope from research and drug development to patient-related care and who remain dedicated to advancing clinical pharmacology with the ultimate goal of enhancing patient care. ACCP seeks to address the educational needs of its diverse membership and all healthcare professionals, covering a range of topics that span the entire area of the interaction between drugs and humans.
Dr. Novack’s article on pharmacological prophylaxis of myopia was published in a special issue of Eye and Contact Lens. This issue (Volume 44 / Issue Number 4, July 2018) features articles on Myopia Control: Current thoughts and future research. It was edited by Drs. Penny A. Asbell and Kazuo Tsubota. The publication is based upon a symposium held in November 2017 in Tokyo at Keio University. The issue includes authors from a wide variety of perspectives. All agree – myopia is an epidemic that will continue to take medical resources to deal with the increasing number of affected patients worldwide.