WASHINGTON, D.C. — The U.S. Food and Drug Administration is rolling out a sweeping set of initiatives aimed at reshaping the nation’s drug and food systems, launching a new pilot to onshore pharmaceutical manufacturing, loosening rules to speed the shift away from petroleum-based food dyes, and warning companies marketing non-approved weight-loss drugs that enforcement is coming.
On February 1, the FDA began accepting applications for its new FDA PreCheck pilot program, an effort designed to strengthen the domestic pharmaceutical supply chain by giving manufacturers earlier and more predictable regulatory engagement. The program is intended to encourage companies to build drug manufacturing facilities in the United States and shorten the path from construction to production.
Under PreCheck, the FDA will select an initial group of new pharmaceutical manufacturing sites to participate in 2026. Facilities will be evaluated based on alignment with national priorities, including the types of drugs they plan to produce, how close they are to becoming operational, how quickly they can supply the U.S. market, and whether they are manufacturing critical medications.
The program is divided into two phases. In the first, FDA staff will work with manufacturers during facility development, providing early technical advice and conducting pre-operational reviews before a plant is fully up and running. In the second phase, the agency and applicants will coordinate through pre-submission meetings and inspections to speed reviews tied to specific drug applications.
The FDA said the pilot was shaped by extensive industry feedback gathered during a public meeting on onshoring drug and biological product manufacturing held in September 2025, as well as comments submitted through the Federal Register.
Days later, on February 5, the agency announced additional steps to help transition the nation’s food supply away from artificial petroleum-based colors. Under the new approach, companies will be allowed to label products as containing “no artificial colors” if they avoid petroleum-based dyes, even if they use colors derived from natural sources. Previously, such claims were generally limited to products with no added color at all.
The FDA said it will exercise enforcement discretion for these voluntary labeling claims and has notified industry of the change. The agency also approved beetroot red as a new color additive and expanded approved uses of spirulina extract, both derived from natural sources. Those actions bring the total number of new food color options approved under the current administration to six.
The FDA and the Department of Health and Human Services have been tracking industry commitments to remove petroleum-based dyes from food products, with progress posted online at https://www.fda.gov/food/color-additives-information-consumers/tracking-food-industry-pledges-remove-petroleum-based-food-dyes.
On February 6, the agency added a tougher enforcement message, announcing plans to restrict the use of GLP-1 active pharmaceutical ingredients in non-FDA-approved compounded drugs that are being mass-marketed as alternatives to approved treatments. The FDA said it cannot verify the safety, quality, or effectiveness of those compounded products and warned that companies making unsubstantiated claims could face legal action.
The agency said it is also intensifying scrutiny of direct-to-consumer advertising after warning letters sent in late 2025, reminding companies they cannot claim compounded products are equivalent to FDA-approved drugs or are clinically proven to deliver the same results.
Together, the moves signal a more aggressive posture by the FDA, combining incentives to bring drug manufacturing back to U.S. soil, regulatory changes aimed at reshaping food labeling, and stepped-up enforcement against what the agency says are misleading and potentially dangerous pharmaceutical practices.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.