Rick Collins Featured in Two Natural Products Insider Articles

Rick Provides Critical Information for Supplement Companies in Bylined Article ““Launching a New Dietary Supplement Product”; Offers Insight on Two Recent Studies

Rick Collins is featured in two recent articles in Natural Products Insider, providing important information for supplement companies on the issues and latest regulations affecting the industry today. The articles offer insight into how supplement companies today can best comply with the law regarding dietary supplements and new dietary ingredients – as well as offer commentary on two recent studies published in Clinical Toxicology and the Journal of the American Medical Association.

In his article “Launching a New Dietary Supplement Product” (Natural Products Insider, December 4th) Rick provides supplement companies with a valuable overview of FDA’s revised August 2016 Draft Guidance on the process of evaluating a new dietary supplement product in order to ensure compliance with FDA guidelines. With many supplement companies and manufacturers today receiving FDA warning letters and facing possible product recalls due to issues surrounding New Dietary Ingredients (NDIs) – and with the 102 page August Draft Guidance from the FDA overwhelming to many companies, Rick offers a streamlined summary of the most important issues that supplement companies/manufacturers need to address before launching a new product in today’s regulatory environment. The article provides an important list of questions that marketers need to ask themselves prior to launching a product. Rick offers insight into the latest legal information — and FDA guidelines — that must be considered in preparation for a product’s launch.

Specific questions Rick addresses (and provides critical insight on) in his article surrounding what supplement companies/manufacturers need to ask themselves prior to launching a new dietary supplement product include:

  • Whether the product meets the definitional criteria of a dietary supplement;
  • Whether the product contains one or more dietary ingredients;
  • Whether the dietary ingredient was marketed in the United States for use in dietary supplements prior to October 15, 1994, which was the year DSHEA was enacted. If the ingredient was not marketed in the US as a dietary supplement ingredient prior to Oct. 15, 1994 then it is considered an NDI.

Rick’s article goes on to address different categories of NDIs and the difference between NDIs requiring pre-market notification to FDA and those that are exempt from the notification requirement – and what supplement companies need to know and do regarding NDIs in each category. The article also addresses NDIs that are an herb or botanical, and the FDA’s current position on this issue.

In addition to his published article in NPI, Rick was also recently quoted in Steve Myers’ NPI article addressing a new study concerning “products marketed for controversial novel sports ingredients that often don’t contain what’s on the label or contained unlabeled, unapproved drugs.” The article focuses on Dr. Pieter Cohen’s published paper in Clinical Toxicology (reporting that controversial stimulants were found in sports supplements, and that lab tests revealed some of the stimulants found were not what was listed on the labels) and the November 20th 2017 JAMA study looking at products labeled as containing SARMs. Rick makes clear that “SARMs should not be sold as dietary supplement ingredients as they are not compliant with DSHEA. However, he also points out that the “illegal sale of SARMs to bodybuilders under the ruse of ‘research chemicals’ [which] has been the subject of Department of Justice prosecutions and convictions” is a “separate issue and outside the dietary supplement market.”

Both articles offer important information for dietary supplement companies and manufacturers, and address some of the most timely issues facing the industry today. In addition, for more specific information about launching a new dietary supplement product in today’s regulatory environment and how to ensure FDA compliance surrounding NDIs, and for any additional questions surrounding SARMs and other ingredients, you can contact Rick directly at rcollins@supplementcounsel.com, or call him at 516-294-0300. Rick and his team can provide the legal guidance needed to launch compliant products in today’s supplement industry, and can answer any questions you may have before it is possibly too late.

To read Rick’s full article “Launching a New Dietary Supplement Product” in Natural Products Insider, click here.

To read the NPI article “FDA, Industry Struggle to Deal with SARMs, DMAA and Other Controversial Ingredients, click here.