RE: FDA draft guidance on Substantial Evidence of Effectiveness for Human Drug and Biological Products

The Center for Science in the Public Interest respectfully submits these comments regarding the Food and Drug Administration’s draft guidance titled “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.” We appreciate the agency issuing a draft guidance to clarify, in part, how drug developers “can rely on one scientifically rigorous adequate and well-controlled clinical investigation with confirmatory evidence to satisfy the statutory substantial evidence of effectiveness standard.” The new draft guidance explains that the substantial evidence standard can be met either with one adequate and well-controlled trial plus confirmatory evidence or with more than one adequate and well-controlled trial. The draft guidance then lays out two ways of meeting approval standards with only a single trial: 1) “evidence from an adequate and well-controlled trial plus a source of strong confirmatory evidence,” and 2) “evidence from a highly persuasive adequate and well-controlled trial plus early-phase confirmatory evidence.” View the resource below to keep reading.

CSPI urges Senate not to confirm Overton as FDA Commissioner

CSPI urges the Senate to block Heidi Overton’s FDA nomination amid concerns about vaccine misinformation and anti-reproductive health stances.

Nicotine is back—but is it really a wellness hack?

Modern day nicotine marketing echoes old Big Tobacco tactics, promoting pouches, gums, and mints with focus or performance claims—while health risks persist.

Newsom urged to sign AB2030 supplement restriction for minors

California AB-2030 bans selling weight-loss and muscle-building supplements to minors; CSPI urges Gov. Newsom to sign to shield children from unsafe products.

Letter to Gavin Newsom RE: AB 2030 (Lowenthal)

"Dear Governor Newsom, The Center for Science in the Public Interest proudly sponsors AB 2030, which would prohibit the sale of over-the-counter diet pills and weight-loss or muscle-building dietary supplements to minors. As the bill passed the legislature on August 27, 2026, we respectfully request you sign the AB 2030 into law." View the resource below to keep reading.

Non-UPF labels: Useful new tool or cause for confusion?

New labels assure you that the product you’re buying is not an ultraprocessed food. But what does that even mean?

RFK Jr. leaves GRAS loophole ajar

Senators introduce legislation to promote transparent food labels

Comments RE: Pharmacy Compounding Advisory Committee meeting on bulk drug substances nominated for inclusion on the Section 503A bulk drug substance list

"The Center for Science in the Public Interest, an advocacy group that accepts no funding from industry, opposes the proposed inclusion of the seven bulk peptide drug substances (BPC-157, KPV, TB-500, MOTs-C, emideltide, semax, and epitalon) in the 503A Bulks List, allowing them to be compounded, because this action is inconsistent with the FDA’s own standards for pharmacy compounding, poses dangers to consumers, and removes incentives for developing new pharmaceutical products through the standard drug approval process.   Agency scientists recently reviewed the available data for these seven bulk drug substances in detail and recommended that all seven “NOT be included in the 503A Bulks List” (emphasis in the original) because of the overall lack of data to characterize the substances’ historical use, physical and chemical properties, safety profile, and effectiveness. We support the career scientists’ determinations and urge the committee and subsequently the agency itself to follow the recommendations of the FDA’s own subject matter experts. " View the resource below to keep reading.

How fixing food date labels could reduce waste and confusion

Confusion around food date labels leads 88% of consumers to discard food that's still good to eat. Standardizing date labels could lead to lower food waste.