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news October 21, 2024

New FDA Guidance on Use of Electronic Systems, Records and Signatures in Clinical Investigations

This month, the U.S. Food and Drug Administration (FDA) issued a new broad-reaching guidance document for clinical investigation sponsors, clinical investigators, institutional review boards (IRB), contract research organizations (CRO), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations. See FDA guidance document entitled “Electronic Systems, Electronic […]

news October 16, 2024

The New Negative Option Rule is Here!

The FTC has finalized its updated Negative Option Rule, also known as the “Click to Cancel” Rule.

news October 5, 2024

Ivan Wasserman Quoted in “Bill Would Make Big Change to GRAS System”

Ivan Wasserman discussed a new bill before Congress that would change how companies bring new ingredients to market in the Oct. 4 issue of SupplySide Supplement Journal.

news October 2, 2024

If You Are Offering Customers an Automatic Renewal or Membership Service, Be Advised: California’s New Law Takes Effect July 1, 2025

Last week, California Governor Gavin Newsom signed Assembly Bill 2863, which amended California’s automatic renewal/continuous service law. There are some important changes to the law that go into effect on July 1, 2025.

news September 16, 2024

New Jersey Law Establishing THC Limits and Age Restrictions Signed Into Law

On Thursday, Sept. 12, New Jersey’s Governor signed into law legislation that prohibits the sale or distribution of a product intended for human consumption that contains THC in any detectable amount to those under 21 years of age. The bill also defines “hemp product” as a product with not more than 0.5 mg of total […]

news September 11, 2024

California Emergency Regulation Prohibiting THC in Hemp Products

On Sept. 6, 2024, the California Dept. of Public Health issued a notice of intent to file an emergency regulatory action that would prohibit the manufacture, warehousing, distribution, offer, advertising, marketing, or sale of any hemp product intended for human consumption containing “detectable” THC, including foods, beverages, and dietary supplements.

news September 9, 2024

Former Walmart Lead E-Commerce Counsel Char Pagar Joins Amin Wasserman Gurnani

Char Pagar has joined the firm’s Washington, DC office as Counsel in the firm’s Regulatory Group. She was formerly lead e-commerce counsel at Walmart, senior marketing counsel at Sears, and an attorney in the Bureau of Consumer Protection at the Federal Trade Commission.

news July 26, 2024

Bob Durkin Quoted in “AHPA Supports Sen. Durbin Bill to Create Separate Federal Food Agency”

Senior Editor Hank Schultz, Natural Products Insider, turned to Bob Durkin for perspective on a new bill that would create two new agencies: the Federal Drug Administration and the Federal Food Administration.

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Ivan Wasserman Quoted in “RFK, Jr. Seeking to Eliminate Self-Affirmed GRAS”

Ivan Wasserman commented on Health and Human Services Secretary Robert F. Kennedy, Jr.’s directing acting FDA Commissioner to explore eliminating the self-affirmed GRAS pathway for ingredients for NutraIngredients USA.

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