Food and Drug Administration

Botulism is uncommon in dairy products, and there is no historical precedent of commercially produced infant formula causing infant botulism, according to U.S. regulatory authorities.

ByHeart entered the infant formula market in 2022, and ByHeart products represented approximately 1% of infant formula sold in the United States as reported by the U.S. Food and Drug Administration.

Appropriations bills commonly provide funding for federal departments and areas such as the Department of Agriculture, the Food and Drug Administration, the Department of Veterans Affairs, military construction, and the legislative branch.

It is highly unusual for an FDA regulator to single out individual companies and specific products in public comments posted online.

As of 2025-11-03, the FDA's drug center reported losing more than 1,000 staffers over the prior year to layoffs or resignations.

A 2025 Gallup nationwide poll found that Americans' approval ratings for six major federal agencies—FEMA, the CIA, the CDC, the FDA, the EPA and the IRS—declined compared to 2024 and were at or near their lowest levels in Gallup records dating back to 2003.

The Food and Drug Administration published a biosimilars approval pathway in 2015 that recommends comparative studies demonstrating similar patient responses between proposed biosimilars and reference biologic drugs.

A 2010 U.S. federal health reform law directed the Food and Drug Administration (FDA) to establish an approval pathway for biosimilar drugs.

The U.S. Food and Drug Administration states that gray-market GLP-1 drugs obtained outside the legal drug supply chain are not evaluated for safety, quality, or efficacy and may be counterfeit, contaminated, or improperly compounded.

The U.S. Food and Drug Administration monitors and regulates lead levels in foods to protect public health.

The Food and Drug Administration's drug center is the largest division of the FDA and is responsible for the review, safety, and quality control of prescription and over-the-counter medicines.

FDA-approved botulinum toxin products carry a boxed warning that the medications can cause serious or life-threatening side effects; in rare cases the toxin can spread beyond the injection site and paralyze or weaken muscles needed for breathing and swallowing.

U.S. Medicare and Medicaid programs cover drugs that the U.S. Food and Drug Administration has approved for treatment of Type 2 diabetes.

Congressional appropriations are commonly structured as separate funding bills that can cover areas such as military construction and the Department of Veterans Affairs; the Department of Agriculture and the Food and Drug Administration; and operations of the legislative branch.