Synaptent, LLC
FDA issued a warning letter to Synaptent, LLC (operating liftmode.com) in November 2021 for marketing numerous dietary supplement products—including Phenibut, Berberine HCL, Curcumin, and others—with disease treatment and drug-effect claims that rendered them unapproved new drugs under the FD&C Act. The agency cited claims such as anti-inflammatory, anxiolytic, blood pressure reduction, and erectile dysfunction uses as evidence of drug intent without FDA approval. Several products were also cited as misbranded drugs for lacking adequate directions for use, and four products were cited as misbranded dietary supplements for incomplete labeling. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (24)
Dihydromyricetin . . . is used for anti-inflammatory, anti-hangover . . . benefits.
Plants with high levels of dihydromyricetin are commonly incorporated into traditional Chinese medicine (TCM) and traditional japanese [sic] medicine (Kampo) for fevers, jaundice and other inflammatory illnesses.
The resin extracted from Boswellia serrata is an extremely powerful anti-inflammatory due to its ability to prevent the biosynthesis of leukotrienes, which has been found to be a major source of inflammation in the body.
Honokiol and Magnolol have numerous protective health benefits based on their . . . antibacterial, antineoplastic . . . effects.
It is also taken anecdotally for blood pressure control due to its potential diuretic activity and general cardioprotective activity
It . . . was once used as a treatment for diarrhea in diabetics.
Boswellia serrata . . . has been used . . . as a remedy for diarrhoea [sic] and inflammation.
Powerful Anti-inflammatory
Tongkat Ali (Eurycoma longifolia) . . . has long been traditionally used as a medicinal plant in a variety of folk medicine preparations for ailments which range from malaria to erectile dysfunction.
Boost Your Mood [] Reduce Your Stress
Boswellia serrata . . . is taken . . . for its perceived effect in reducing joint pain . . .
Fisetin is a potent anti-inflammatory agent and directly inhibits the activity pro-inflammatory cytokines such as TNFα, NF-κB, and IL6.
Studies have highlighted the role of garlic in preventing and managing bacterial and fungal infections.
Milk Thistle has been shown to exhibit anti-inflammatory. . . properties . . .
Lion's Mane contains polysaccharides such as heteroglucans which protect the nervous system by improving neurite outgrowth in the brain – meaning they increase the growth of new axons and dendrites, components of brain cells, which may reduce inflammation in the brain and protect it from cell degeneration.
The Silymarin content within Milk Thistle extract has been found to . . . reduce insulin resistance . . ..
It is taken commonly to help reduce the symptoms of hangover and protect the liver against inflammation, especially caused by alcohol use.
Phenibut or β-Phenyl-γ-aminobutyric Acid is a nootropic compound with GABA-B agonist and α2δ subunit-containing voltage-dependent Ca2+ channel blocker activity, that has neuroprotective and anxiolytic properties.
Studies indicate that Honokiol can be used as a powerful . . . anti-inflammatory, and antimicrobial . . .
It is especially beneficial for use by diabetics and people with high cholesterol, who are at risk of developing diabetes.
Baicalein also acts as a strong anti-inflammatory . . .
Clinical trials also suggest that garlic may improve heart health by reducing blood pressure. Most clinical trials support the role of garlic supplementation in lowering blood pressure.
Curcumin is an extremely powerful anti-inflammatory . . .
Anti-inflammatory
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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