GeroNova Research Inc.
FDA issued a warning letter to GeroNova Research Inc. (President Karyn Young) in November 2021 after reviewing the company's Amazon store, Facebook, Twitter, and website for products including CARNITINE PLUS Vegcaps, GeroNova Beauté Infinie Elixir, R-Lipoic Acid Vegcaps 300 mg, and R-Lipoic Acid Vegcaps 100 mg. The agency found that marketing claims on these platforms — including references to treating diabetes, cardiomyopathy, Parkinson's disease, depression, neuropathy, and liver disease — rendered the products unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. FDA demanded a written response within 15 working days detailing corrective steps, and warned that failure to comply could result in seizure or injunction.
Flagged claims (12)
Improve mitochondrial function in Nonalcoholic Steatosis (liver disease) by stimulating Sirtuin-1 and Sirtuin-3 proteins
. . . slows signs of . . . cardiovascular and neurological disorders
research demonstrated that acetyl-l-carnitine [an ingredient in your CARNITINE PLUS Vegcaps] supplementation inhibited insulin resistance through AMPK stimulation… acetyl-l-carnitine administration: Restored Sirtuin-3 activity . . .
'Possess anti-diabetic and anti-obesity properties,' [footnote omitted] as it both increases insulin sensitivity through AMPK activation [footnote omitted] and a reduces insulin in pancreatic beta cells
Carnitine [an ingredient in CARNITINE PLUS Vegcaps and GeroNova Beauté Infinie Elixir] does so much in this one. #diabetes
IMPROVE BLOOD SUGAR LEVELS: Studies have shown that L-carnitine … while improving insulin resistance.*
a reduction in sirtuins was associated with aggressive disease-states such as diabetes and insulin resistance…Equally as important, a reduction in AMPK was associated with cardiomyopathy…
research demonstrated that mitochondrial dysfunction, aging, autism, cardiomyopathy, many errors in metabolism, dislipidemia, and renal disease are among just a few of the remarkable clinical areas in which the addition of carnitine supplementation demonstrated an essential role in improved outcomes.
#carnitine supplementation stabilises hyperglycaemia and increases the metabolism of pyruvate in the diabetic heart. l-carnitine provides a means to improve pyruvate metabolism in the #diabetic heart
In fascinating Parkinson's disease pre-clinical research modeling, Acetyl-L-Carnitine improved cognitive function, extended neuronal survival and modulated key imbalances between cytokines.
supplemental Acetyl-L-Carnitine: 'significantly decreases depressive symptoms compared with placebo/no intervention, while offering a comparable effect with that of established antidepressant agents with fewer adverse effects.'
#lipoicacid [an ingredient in your R-Lipoic Acid Vegcaps 300 mg and R-Lipoic Acid Vegcaps 100 mg] model treats autonomic neuropathy… @geronova is the best! I've tried it.
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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