Saffron Health Sciences
FDA issued a warning letter to Saffron Health Sciences (Dr. Song Gao, E Brunswick, NJ) in November 2021 regarding three dietary supplement products — Crocin Rich, Crocin Rich II, and Crocin Rich Plus — marketed with disease-treatment claims covering Alzheimer's, COVID-19, multiple sclerosis, stroke, depression, macular degeneration, and other conditions. The agency determined these claims caused the products to be classified as unapproved new drugs under the FD&C Act, and also found them misbranded for lacking adequate directions for use. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (18)
Crocin, the unique water-soluble carotenoid with potent … anti-inflammation effects, could be a promising natural agent to boost immune system and body defense against COVID-19.
Dozens of clinical and hundreds of preclinical studies in recent years revealed crocin/saffron having significant effects to improve conditions in patients with Alzheimer's, mild cognitive impairments, vascular dementia, age-related macular degenerative (AMD), stroke, depression, multiple sclerosis, and a few other diseases.
Crocin was found to prevent generation of toxic amyloid peptides through inhibiting two key enzymes in Alzheimer Disease Neuronal Cell Culture Models ….
Protective effects of crocin on clotting: Crocin has been reported in series of recent studies to suppress plasminogen activator inhibitor-1 (PAI-1) activity to ameliorate thrombosis …, inhibit atheromatous plaque formation … and inhibits [sic] platelet aggregation …. These findings indicate effects of crocin could potentially prevent and reduce the impacts of COVID-19.
Human studies in recent years further indicated that the antidepressant-like properties of saffron are primarily due to crocin. In a 4-week study, crocin (30mg/day) effects on depression were compared with a serotonin reuptake inhibitor drug (fluoxetine, sertraline, and citalopram) in a randomized, double-blind, placebo-controlled, pilot clinical trial. Results of this human study showed crocin significantly improved scores on BDI, BAI, and GHQ compared to the placebo group. The authors concluded crocin could be administered as an adjunctive treatment in major depressive disorder patients.
[C]rocin has been shown in at least 20 animal studies to improve memory deficits induced by amyloid and other drugs or toxins … Therefore, Crocin is considered as an effective option … against Alzheimer's.
[W]e identified crocin, the most important active constituent of saffron, as the best natural … anti-inflammatory agent .…
CROCIN RICH plus Is Good For … Help recovery of nerve and traumatic injury
Without a vaccine and cure available for coronavirus (COVID-19), an alternative for the prevention and mitigation of the impact of COVID-19 could come from unique natural products with multi-target and immune system boosting effects.
Clinical studies of saffron and its main active constituent crocin in recent years suggested that supplementation with crocin or saffron may have positive effects on various vision-related parameters in adults with age-related macular degeneration (AMD), glaucoma, diabetic maculopathy, and Stargardt macular dystrophy.
CROCIN RICH II Is Good For … Help recovery of nerve and traumatic injury
Crocin supplements are designed for … Alzheimer's … Macular degeneration (AMD), diabetic maculopathy
Clinical findings indicate crocin/saffron supplementation is superior and provide markable eye health benefits in comparative studies to AREDS 2 formula.
Protective effects of crocin on lungs: Lungs are initially believed to be the main organ affected by COVID-19. Crocin was recently reported to attenuate lung inflammation, pulmonary vascular dysfunction and associated pulmonary fibrosis, as well as alleviate acute respiratory distress syndrome in animal studies ….
Crocin Supplements for Healthy Aging and Quality of Life: A natural multi-target approach for Alzheimer's and age-related diseases
A Natural Composition with Multi-Target Neuroprotective Effects for Alzheimer's.
[C]rocin as a natural neuroprotective agent could help reduce risk of stroke and improve recovery.
The results suggest crocin as a promising therapeutic agent in prevention of progressive injury during MS.
Required actions (3)
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.
We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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