Own-Label Multi-Level Marketer 'Repeatedly Warned' And 'Dissolved,' But Distributed Supplements Until Shut Down

DoJ complained filed Tennessee federal court also says the firm, identified as Basic Reset and as Biogenyx in Hendersonville, TN, distributed a noncompliant device branded Energy FX, a pendant for pets and people that emits "positive healthy energy" that "overrides the negative [electromagnetic frequencies] pollution."

A Tennessee multi-level marketer disincorporated after receiving a Food and Drug Administration warning letter and additional notifications but continued distributing dietary supplements until a complaint for permanent injunction was filed in late August.

The complaint the Department of Justice filed on 26 August in US District for the Tennessee Middle District also...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

NPA On Clock To Continue Challenge To FDA ‘Drug Preclusion’ Policy For Dietary Ingredients

 

FDA rejects NPAs arguments for clarity on when it recognizes start of investigational new drug programs and what constitutes “substantial clinical investigations” for an IND. Clock starts after FDA met twice-extended deadline to provide answers to NPA’s questions in a 2023 petition.

US FDA Facility Inspections, Website Reviews Paused With FY 2026 Budget On Hold

 

Continuing work includes “for cause and certain surveillance inspections of regulated facilities” and “criminal enforcement work and certain civil investigations” as White House mulls layoffs rather than furloughs during federal government shutdown.

‘Lawful’ Marketing Not Necessary For Dietary Ingredients To Beat ‘Drug Preclusion’ Date

 

In change with potential to help supplement firms establish availability of dietary ingredients in US predates their use in drugs, FDA grants argument by NPA and CRN that marketing of ingredients dates to even when they use in supplements may be unlawful under agency regulations.

US Supplement Industry Suffers Setback From FDA In Battle Against Impediments To Innovation

 

FDA responds to trade groups' citizen petitions saying it wouldn’t change its policies for when INDs are registered, dates which could preclude subsequent introductions of dietary ingredients, and what constitutes “substantial clinical investigations” in INDs.

More from Policy & Regulation

US FDA Facility Inspections, Website Reviews Paused With FY 2026 Budget On Hold

 

Continuing work includes “for cause and certain surveillance inspections of regulated facilities” and “criminal enforcement work and certain civil investigations” as White House mulls layoffs rather than furloughs during federal government shutdown.

PAGB: UK NHS Risks Missed Opportunity If Digital Self-Care Not Urgently Prioritized

 
• By 

The NHS App should direct users to trusted, external OTC brand resources where appropriate, says PAGB in its latest report.

‘Lawful’ Marketing Not Necessary For Dietary Ingredients To Beat ‘Drug Preclusion’ Date

 

In change with potential to help supplement firms establish availability of dietary ingredients in US predates their use in drugs, FDA grants argument by NPA and CRN that marketing of ingredients dates to even when they use in supplements may be unlawful under agency regulations.