The company, called Saffron Health Sciences, is based in East Brunswick, NJ. It markets three products based on crocin, a bioactive carotenoid constituent of saffron.
Saffron is the spice derived from Crocus sativus, a species of crocus of uncertain origin that is now cultivated in many parts of the world. The spice consists of the vivid red threadlike stigmas of the flower, which are removed and dried. It is often considered the most expensive spice by weight.
When used as a spice the threads are dried and powdered. Medicinal constituents have been extracted from the saffron threads for centuries. Those consituents include crocetin and saffranal in addition to crocin.
Saffron constituents are reputed to have anti inflammatory and antioxidant properties. More recently ingredient manufacturers have studied it for its potential in mood support and cognition.
More recently, a study done in Iran suggested crocin might be beneficial in reducing cholesterol.
Products claimed to have effects on many conditions
In the warning letter, which was the result of a review of the company’s website and social media accounts and did not involve an inspection, FDA cited numerous disease claims the company was making on the ingredient. Despite the research backing the ingredient, the marketer seemed to have cast a very wide net for the ingredient’s effects.
According the warning letter, the company claimed its products as “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.”
Legal experts contacted by NutraIngredients-USA have observed in the past that claiming to ‘improve conditions’ and mentioning specific diseases in the same breath is likely to provoke a strong response from FDA. However, the warning letter also contained some observations of a less inflammatory nature, such as:
“Published study results have revealed multi-target effects of crocin in modulating … inflammatory cytokines ….”
As with other warning letters of this sort FDA has given the company 15 days to respond. The letter was posted yesterday but was dated Nov. 18. As of this writing of this article, some of the blog pages and other postings mentioning the disease claims were still up on the company’s site.
Saffron Health Sciences did not respond in time for publication to a request for comment.