November 19, 2018
“I don’t make jokes. I just watch the government and report the facts.”
—Will Rogers, American actor
Jan. 20, 2017, changed the outlook of the industry.
The presence of the new federal administration has generated more discussion in this industry than any other change in the past 30 years. The speculation on the “rollback” of regulations waved through the industry. What we found in the “rollback” of the regulations was not as fulfilling as hoped for. Sure, the implementation of new labeling regulations for foods and dietary supplements was delayed, but little else has affected the industry. Under the current administration, two secretaries have overseen the U.S. Department of Health and Human Services (HHS, the person at the top of FDA), and one person is in charge of FDA itself. The forestalling regulations or abolishment of others did not come to pass, nor is it likely to. The relatively unsettled nature of the many federal agencies has added to this benign neglect on the part of government agencies, including FDA. The makeup of Congress was supposed to afford the best opportunity to potentially implement change in the Federal Food, Drug and Cosmetic Act (FD&C), a “re-opening of the Dietary Supplement Health and Education Act (DSHEA).” That did not happen either, and with the midterms closing in, that prospect appears to have dimmed. The incoming Congress will be a different beast.
The reality is the federal government is populated by more than just the administration. The perspective of the administration and its effects did not change the actions of thousands of federal employees who march to individual orders. The re-organization of FDA from a division to an office that took place over a year ago had a greater effect on the overall activity of the agency than anything the current administration is likely to do.
The regulatory landscape and consequences of non-compliance are changing in a more active, sometimes punitive manner. This is also part of the federal government and it has not been slowed down by any change at the top. While the industry has had some successes, such as the opportunity to now grow hemp in the United States, the overall trajectory of regulatory activity, enforcement and change remains on the same arc it has been since the passage of DSHEA.
The real update regarding the federal Government is the same as it has been for decades. The industry has been reactive to all things regulatory and statutory. It has been ever thus. The real opportunity lies in the fact that this is a federal government that is likely to be reshaped by the year end. Preparation for that should have begun a while ago by fostering a specific agenda and generating meaningful political contacts, just like the industry should be doing in quiet times. The development of that agenda is critical. Then, the composition of the federal government must be considered as an opportunity to forward that agenda.
Lastly is the matter of the industry working in cooperation with the government. The industry must insist to the government that the industry knows itself best and thus should have the lead in determining regulations.
The industry should view the federal government in the long term, instead of the immediate. That means an agenda that makes sense, is unified and supported by all quarters of the industry. That way, when change occurs within the government, as it does on a biennial basis, the approach is toward forwarding the agenda, rather than reacting to what comes next.
As chief operating officer, Jim Lassiter oversees all consulting operations at Ingredient Identity He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma Inc., Irwin Naturals, ChromaDex, American Herbal Products Association (AHPA) and Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.
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