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EPH Warned On Opioid Treatment Claim For Enzyme, Amino, Peptide Blend

 
• By Malcolm Spicer

EPH Technologies apparently heeds FDA's warning, which also noted violative drug and disease claims for nasal sprays. EPH continued selling other supplements on 2 December, but the three that FDAcited in 18 November warning were not available.

Sinoplex Nasal flush label
EPH Technologies' Sinoplex nasal spray is labeled as containing "Xtremoplex (proprietary blend of all natural proteins, enzymes, amino acids, minerals and peptides)."

Cannabidiol isn't the only ingredient in products marketed as dietary supplements that US regulators say shouldn't be offered as treatment for opioid addiction. The Food and Drug Administration also recently warned EPH Technologies Inc. about opioid withdrawal treatment claims for its Detoxoplex supplement.

The Aztec, NM, firm apparently heeded the FDA's 18 November warning, which also noted violative drug and disease claims for its Sinoplex and Migrenza nasal sprays. EPH continued selling other supplements on its website 2 December, but the three that the Center for Drug Evaluation and Research's Office of Unapproved Drugs and Labeling Compliance cited in the

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More from Compliance

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

 
• By Malcolm Spicer

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.

Accelerating Natural Options Among US FDA’s Steps For Removing Petroleum-Based Food Dyes

 
• By Malcolm Spicer

HHS Secretary Kennedy commends food companies for cooperating, but also says, “We have them on the run now and we are going to win this battle. And four years from now, we're going to have most of these products off the market.”

Deleting Self-Affirmed GRAS Option Could Stretch FDA’s Already Thin Food Safety Resources

 
• By Malcolm Spicer

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.

Traceability Rule Compliance Extended For Providers Of Herbals, Other Food Ingredients

 
• By Malcolm Spicer

FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”

More from Policy & Regulation

Accelerating Natural Options Among US FDA’s Steps For Removing Petroleum-Based Food Dyes

 
• By Malcolm Spicer

HHS Secretary Kennedy commends food companies for cooperating, but also says, “We have them on the run now and we are going to win this battle. And four years from now, we're going to have most of these products off the market.”

US Plans End To Petroleum-Based Dyes In Food

 
• By Malcolm Spicer

HHS Secretary Robet F. Kennedy Jr. and FDA Commissioner Marty Makary to announce planned changes as “a major step forward” as part of Kennedy’s “Make America Healthy Again” campaign President Trump has adopted for his administration.

Deleting Self-Affirmed GRAS Option Could Stretch FDA’s Already Thin Food Safety Resources

 
• By Malcolm Spicer

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.