Letter to FDA Commissioner Dr. Martin A. Makary RE: regulation of laboratory developed tests

We write to you regarding the District Court for the Eastern District of Texas’s March 31 decision in an industry-initiated lawsuit challenging FDA’s authority to regulate Laboratory Developed Tests (LDTs). As you know, the court ruled, in its primary finding, that LDTs are services, not devices, thereby setting aside a final rule that had been in the works at FDA for years. We expect the Agency is concerned about an opinion that removes authority from FDA over an important subset of medical products and erodes the Agency’s authority to ensure safe and effective diagnostics are on the market. View the resource below to keep reading.

Government Accountability

CSPI urges removal of ineffective oral decongestant phenylephrine from market

Government AccountabilityMay 6, 2025

Docket No. FDA-2024-N-4734-0001: Amending Over-the-Counter Monograph M012

The undersigned individuals write in strong support of the Food and Drug Administration’s November 8, 2024, proposed order to remove the oral decongestant phenylephrine as a nasal decongestant active ingredient from OTC Monograph M012. Data provided to the agency and summarized in the FDA’s Briefing Document for the Nonprescription Drug Advisory Committee meeting on September 11-12, 2023, confirm that oral PE is barely absorbed into the bloodstream and that the best conducted clinical trials provide no evidence of efficacy on relevant clinical outcomes. View the resource below to keep reading.

Government Accountability

CSPI letter of support for CA SB646

The Center for Science in the Public Interest is pleased to support SB 646 (Weber Pierson), which strengthens maternal and fetal health protections by requiring manufacturers to test and publicly disclose the levels of four toxic heavy metals—arsenic, cadmium, mercury, and lead—in all prenatal vitamins sold or distributed in California. View the resource below to keep reading.

Industry Accountability

multicolored popcorn colored with synthetic food dyes

FDA's 'plan' to remove food dyes: Industry 'understanding'

FDA announced a 'plan' to phase out synthetic food dyes, then revealed that it is entirely voluntary and requires 'understanding' from food manufacturers.

Food AdditivesApril 22, 2025Zachary Goldstein, MS

A spoonful of artificially colored cereal

FDA signals intent to phase out synthetic dyes from food supply

Food AdditivesApril 21, 2025Peter Lurie, MD, MPH

FDA floats chaotic reorganization as staff purges continue

Government AccountabilityApril 7, 2025Peter Lurie, MD, MPH

Closeup of grocery store worker increasing prices on cooking oil from $5.29 to $6.29. Rising food costs concept.

Trump’s tariffs and trade wars threaten our food security

The full tariffs Trump threatened on 90 countries' imports take effect April 5-9, 2025. Here’s what to know about tariffs, our food system and grocery prices.

Government AccountabilityApril 4, 2025Christina Lin, Adrienne Crezo

RFK's cuts to FDA are a threat to public health and safety

Government AccountabilityApril 1, 2025Sarah Sorscher, JD, MPH

Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.

RFK Jr.’s gutting of the FDA will undermine food, medical product safety, innovation

Statement by Dr Peter Lurie, CSPI President

Government AccountabilityApril 1, 2025Peter Lurie, MD, MPH