UNPA / FDA FY 2019 Congressional Budget Update

Dear Colleagues,

I forward a note just received from Trish Knight and Peter Reinecke which provides an update on legislative activities with respect to FY 2019 funding for FDA.

This note also reports on other interesting points, including the McConnell hemp amendment and the appropriation committee's comments related to dietary supplement enforcement and NDI guidance.

I trust this will be of value to many.

Cordially,

LDI


On Wed, Aug 1, 2018 at 4:19 PM, Patricia Knight <PKnight@knight-cap.us> wrote:

Today, the Senate gave final, strong bipartisan approval (92-6) to a four-bill package which continues funding through FY 2019 for several agencies, including the Food and Drug Administration. The bill includes not quite $3 billion in funding for the FDA, an increase of about $160 million over the current year. The companion bill was considered by the House Committee in May, but has not seen floor action.

During floor debate, the Senate rejected an amendment authored by Senator Mike Lee (R-UT) that attempted to restrict the FDA's authority to enforce standards of identity for food products. The Lee amendment, cosponsored by New Jersey Democrat Cory Booker, was widely seen as being directed toward FDA's milk standard of identity, which strictly read would preclude labeling of products such as "Coconut Milk" or "Soy Milk". Under FDA's current standard of identity, "milk" must come from a lactating animal. Lee used this and the treatment of products such as "vegan mayonnaise" to try to paint a picture that the FDA standards were unreasonable. Only 14 Senators voted in favor of the amendment.

The bill includes the provision authored by Majority Leader Mitch McConnell that effectively removes industrial hemp products from being considered controlled substances. The industry's reading is that the McConnell amendment would NOT change FDA's current position that these products are not legally sold as DS. Nevertheless, it is an important step toward sale of non-THC-containing CBD products on a more widespread basis.

In the report accompanying the bill, the Appropriations Committee included strong language on two areas related to dietary supplements: enforcement; and the NDI guidance.

First, the Committee urged the agency to continue to invest resources into oversight and inspection of DS manufacturing plants. The Committee also urged FDA to continue collaboration with the Department of Justice to remove illegal DS from the market, and they directed unspecified increased resources toward enforcement of DSHEA, including inspection and enforcement activities.

And second, the Committee urged the FDA to issue new dietary ingredient guidance that is consistent with DSHEA, while continuing its work to use current authority to remove unsafe ingredients and products from the market. It also urged that the FDA take current industry standards and market disruption into account if it issued a new NDI guidance document.

Finally, the language directs the FDA to issue a report within 6 months that will help quantify the number of agency enforcement actions in a number of areas. The language is below:

Dietary Supplements.--More than half of Americans take at least one dietary supplement each day, with use particularly prevalent among older persons and in children. While dietary
supplements enter the market under the assumption that they are safe, the FDA has documented that some products are contaminated, either intentionally or unintentionally, with inherently unsafe ingredients, including active pharmaceutical ingredients. These products violate the Dietary Supplement Health and Education Act [DSHEA] and pose potential risks to consumers. The Committee applauds FDA's inspection of and enforcement actions against manufacturers with dietary supplement products that contain ingredients that are potentially harmful or otherwise noncompliant with the law.

FDA has indicated it conducts roughly 500 inspections a year and issues approximately 70-80 warning letters on Current Good Manufacturing Practice [CGMP] violations. In order to better detect dangerous products in the market, FDA is encouraged to continue to invest resources into oversight and inspection of manufacturing plants that produce dietary supplements.

The Committee has been pleased with the interagency collaboration and urges FDA to continue working with the Department of Justice to remove illegal dietary supplements from the market and directs increased resources toward enforcement of DSHEA, including inspection and enforcement activities.

The Committee urges the FDA to issue guidance on new dietary ingredients [NDIs) for dietary supplements that is consistent with the DSHEA while continuing to use current statutory authorities to remove unsafe ingredients and products. The Committee further encourages the FDA to take industry standards and marketplace disruption into consideration when issuing any guidance on NDIs. In addition, the Committee directs FDA to submit, not later than 180 days after enactment of this Act, a report that includes the number of enforcement actions FDA brought against dietary supplement manufacturers and marketers; the manufacturers and marketers of products claiming to be dietary supplements; the number of dietary supplement good manufacturing practice inspections FDA conducted in 2017; the number of FTEs dedicated to dietary supplement inspections; and the number of serious adverse events that were reported to FDA from 2016 to 2017.