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Enforcement

CHPA Navigates Trump Administration’s ‘Mixed Messages,’ Ready To Traverse DSHEA Changes

Some changes the administration has proposed are a “great example of regulating by press release,” says Duffy MacKay, CHPA’s dietary supplements chief. But “after 30 years, the Dietary Supplement Health and Education Act could be modernized to serve the consumer better.”

US FDA Supplement Office Chief Eyes ‘Movement’ This Year On NDI Notifications Final Guidance

“We've made some progress and really hope to see some movement as we move forward this year,” says FDA Office of Dietary Supplement Programs director Cara Welch.

US FDA Expands Surprise Foreign Inspections

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Time’s Up For Time-Line Mitopure Supplement Marketer’s Aging Claims In NAD Review

NAD says Amazentis didn’t substantiate cellular performance and muscle function claims for its supplements containing proprietary ingredient Mitropure but provided “a sufficiently reliable and reasonable basis” for “clinically proven to revitalize mitochondria.”

NAD Asks FTC To Pull Bandage Off Firm’s Plan To Exhaust Inventory Using ‘2X Faster Healing’ Claim

After National Advertising Division attorneys, in a review prompted by a challenge by Band-Aid line marketer Kenvue, recommended ASO LLV cease use of its “up to 2x faster healing” claim, they determined the firm had not fully complied.

Supreme Court 1935 Ruling Limiting Executive Authority On Appointments ‘Unravels’ Today – DoJ

In complaint and response to motion to dismiss, Rebecca Kelly Slaughter’s and Alvaro Bedoya’s attorneys elaborate on Supreme Court ‘s 1935 decision, Humphrey’s Executor v. US. Administration attorneys, though, contend the ruling isn’t relevant to the current FTC.

OPPI’s Matai On Section 3(d) Of India’s Patent Regulations: Now’s The Time To Open Up

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.

Third-Party ‘Testing, Inspection and Certification’ Cleaning Up Amazon Supplement Market

Three FDA warnings related to supplement manufacturing, labeling or marketing submitted to Amazon or companies selling vitamin, mineral or supplement products on its e-commerce platform since April 2024.

Congress, Researchers Highlight Security Risks At DNA Testing Services

Congress launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

Third GOP Seat On Federal Trade Commission Goes To Former DoJ Attorney During Trump’s First Term

Mark Meador most recently worked as a visiting fellow at conservative think tank Heritage Foundation’s Tech Policy Center and worked during Trump’s first term as a trial attorney in the Department of Justice’s Antitrust Division. The two Democrat-appointee seats remain open while the members Trump recently fired contest his controversial decision.

Some New Tools, More Old For Supplement Sector Enforcement During Trump’s Second Term

Tariffs on imports from China and look at eliminating self-affirmed GRAS pathway introduced under Trump while DoJ Consumer Protection Branch also continues supplement sector priorities enduring across administrations.

Availability Of Counterfeit Supplements Ringing Up Impact On Brand Sales And Consumer Safety

Sales of Bioventra’s probiotic put inventory at “a critical low” as “parallel rise in unverified listings on third-party marketplaces prompted concern among” customers. DoJ and food and drug industry attorney say counterfeiting remains a problem in supplement sector.