Dear Colleagues --
We have just received a memo from Peter and Trish (below) regarding the transmittal of the President's budget to Congress. With respect to FDA, the attached memo notes key points. Of particular significance is the budget request for authority to require mandatory label registration for dietary supplements (listing). As noted, this topic was broached by Commissioner Gottlieb in mid-February but now is formalized through the White House budget request to Congress. This now formalizes FDA's position on mandatory product listing, and we believe it lays the foundation for FDA's formal request for legislative action on this and several other DSHEA amendments
We are finalizing a memorandum that lays out our views on what FDA is likely to seek in its DSHEA amendments proposal to Congress.
As you recall, the commissioner announced his resignation effective April 4. The question arose whether the DSHEA amendments' views were being led by the commissioner, or are they institutionalized within FDA? The answer clearly is that FDA's interest to amend DSHEA is an institutional view; therefore, the acting commissioner and any new confirmed commissioner will carry this forward as a significant FDA initiative.
---------- Forwarded message ---------
From: Peter Reinecke <email@example.com>
Date: Mon, Mar 18, 2019 at 4:35 PM
Subject: Budget Details released this afternoon
To: Loren Israelsen <firstname.lastname@example.org>, Patricia Knight <email@example.com>, Frank Lampe <firstname.lastname@example.org>, Larisa Pavlick <email@example.com>
MEMO FOR UNPA MEMBERS:
FROM: Trisha and Peter
Today the President transmitted to Congress the details of his budget, and there are a few of things of note to the dietary supplement community. 1) The budget requests authority to require mandatory label registration – which they call “listing”; 2) they want to cut DS research at FDA; and 3) they highlight their enforcement activities. In the case of 1), Congress would have to pass legislation to authorize and design such a program; and for 2) appropriators would have to agree to this cut, but it is now “sanctioned” by the agency since it is part of the budget. The request for language to support a new listing program makes it much more likely that action could occur on Capitol Hill. As you recall, Commissioner Gottlieb mentioned it recently, but that was thought to be a trial balloon. It is now an official Administration request.
Here is the actual language from the budget justification submitted to Congress today):
In the 25 years since the Dietary Supplement Health and Education Act of 1994 (DSHEA) was enacted, the dietary supplement market in the U.S. has grown from approximately 4,000 products to somewhere between 50,000 and 80,000 products. Under current law, FDA is not clearly authorized to require listing of individual dietary supplement products on the market, and the Agency has no convenient mechanism for compiling basic information about those products. This proposal would require all products marketed as “dietary supplements” to be listed with FDA and give FDA authority to act against non-compliant products and the manufacturers and/or distributors of such products. This would allow FDA to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products, and improve transparency and promote risk-based regulation.
The net increase to the Foods program is $25.3m. The overall increase to the Foods Program funding reflects -$1.8m of base funding based on the proposals laid out in the House report for FY 2019. This includes increasing FDA’s biotechnology education and outreach efforts by $1.5m from FY 2018’s levels and decreasing spending on fish decomposition research and dietary supplement research by $2.8m and $500k from the FY 2018 levels, respectively
“Encouraged the Safe Production of Dietary Supplements
In FY 2018, FDA field investigators completed inspections of both domestic and foreign firms to enforce dietary supplement regulations, including current Good Manufacturing Practices (cGMPs) and labeling requirements. These inspections resulted in:
• 75 warning letters
• 3 untitled letters
• 180 detentions
• 4 injunctions (filed).
Additionally, FDA initiated several regulatory actions aimed at protecting consumers from fraudulent and/or products that were marketed as dietary supplements. These include products marketed as dietary supplements that made unlawful claims about treating opioid use disorder and other products that made unproven claims about protecting consumers from the harms that come from sun exposure without meeting the FDA’s standards for safety and effectiveness.
Premarket notification of new dietary ingredients (NDIs) is FDA’s only opportunity to identify potentially unsafe supplements before they are available to consumers. In FY 2018, FDA responded to 38 NDI notifications. Of the notifications submitted, 10 were deemed incomplete or determined to not pertain to an ingredient intended to be used in a dietary supplement. Of the remaining 28 notifications, FDA acknowledged 17 with no objection and raised safety or identity concerns with 11.
In FY 2017, FDA received more than 2,700 adverse event reports (AERs) related to dietary supplements. The reports are evaluated by clinical reviewers in the Center for Food Safety and Applied Nutrition (CFSAN) to monitor the safety of consumer products. FDA is undergoing a modernization of the CFSAN Adverse Event Reporting System (CAERS) to track when and how an AER is evaluated. In addition, FDA is working on a solution for linking AER data to data on compliance and other FDA actions through the use of a high-end analytics platform tailored for big data. This platform will merge and link multiple internal and external data sets and will be able to track products and adverse events throughout the signal’s lifecycle, including regulatory actions recommended or taken.
FDA Steps Up Efforts to Stop Illegal Sale of Highly Concentrated Caffeine
Products consisting of or containing pure or highly concentrated caffeine have been linked to at least two deaths in the United States in the last few years and continue to present a significant public health threat. Many products that consist of primarily or highly concentrated caffeine are sold as dietary supplements.
In April 2018, FDA issued guidance to industry on highly concentrated caffeine in dietary supplements. This document is intended to provide guidance to firms that manufacture, market, or distribute dietary supplement products that contain pure or highly concentrated caffeine, or are considering doing so.
In June 2018, FDA issued warning letters to parties illegally selling certain highly concentrated caffeine products. These letters build on our efforts to stop illegal sale of highly concentrated forms of life-threatening dose.”