FDA releases FY23 budget request and summary documents
March 31, 2022
This week, the U.S. Food and Drug Administration (FDA) released its FY23 budget request and summary documents, outlining many matters of significant interest to the American Herbal Products Association (AHPA) and its members.
Requests in the budget proposal include:
Budget increase: Increasing the FDA's budget to a total of $8.4 billion, a nearly 34% ($2.1 billion) increase over the agency's FY22 budget.
Mandatory product listing (MPL) and prohibited act revisions: Amending the Dietary Supplement Health and Education Act of 1994 (DSHEA) to “require annual listing with FDA of individual dietary supplement products, including basic information about each unique product” and “clarify FDA's authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products.”
Cosmetics legislation: Calling on Congress to enact legislation that requires domestic and foreign cosmetic manufacturers to register their facilities, list their products, and report serious adverse events to FDA, in addition to granting FDA mandatory cosmetics recall authority and authorizing the agency to collect registration fees from the cosmetics industry.
Expanded authority over remote regulatory assessments: Granting FDA the authority to require "records or other information in advance of or in lieu of inspections" for all regulated product categories. This includes authority to use online tech to conduct these activities, such as screen sharing and teleconferences.
Company-funded destruction of refused items: Revising section 801 of the Food, Drug, and Cosmetic Act to give FDA authority to require the importer to destroy FDA-regulated products that have been refused and present a "significant public health concern" in the agency's evaluation.
Enhanced contamination limit establishment authority: Granting FDA authority to establish binding contamination limits in foods – including “those consumed by infants and young children” – via the administrative order process. FDA is also asking for toxic element testing requirements for foods labeled for consumption by infants and young children.
State information sharing of non-public commodity information: Amending the Food, Drug, and Cosmetic act to allow disclosure of non-public information to state, local, and territorial governments by preempting state, local, or territorial disclosure laws to preserve the confidentiality of non-public information provided by FDA.
This is not the first time FDA has included MPL language in an administration's budget request. For example, FDA previously expressed support for enactment of MPL legislation to provide the agency with this authority in the FY20 budget proposal.
“There remain many unaddressed concerns about MPL proposals – including that any MPL requirement could destabilize the balance that DSHEA struck between informed consumer access and appropriate FDA authority,” said AHPA President Michael McGuffin. “With the goal of modernizing regulation while retaining this balance, AHPA advocates for the removal of obstacles to the dissemination of truthful and not misleading information to consumers. AHPA similarly advocates for amendments to the prior drug exclusion provision to establish a more-reasonable pathway to market for all natural products, even if that means that certain ingredients would eventually exist in both the pharmaceutical and dietary supplement markets.”
The FY23 budget request is available in full on the FDA website.