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WARNING LETTER

Saffron Health Sciences MARCS-CMS 615429 —

Delivery Method:
VIA UPS
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Dr. Song Gao
Saffron Health Sciences

13 Dexter Rd
E Brunswick, NJ 08816-2873
United States

Issuing Office:
Division of Human and Animal Food Operations East II

United States

WARNING LETTER
CMS #615429

November 18, 2021

Dear Dr. Gao;

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the internet address https://saffronhealthsci.com in November 2021 and determined that you take orders there for the products Crocin Rich, Crocin Rich II, and Crocin Rich Plus. We have also reviewed your social media website www.facebook.com/saffronhealthsci/, which directs customers to https://saffronhealthsci.com to purchase your products, and your firm’s store at www.amazon.com. The claims on these websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease, including COVID-19 in people1. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violated the Act. You may find the Act and FDA regulations through links on FDA’s homepage at www.fda.gov.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

On your website homepage (https://saffronhealthsci.com):

  • “Crocin Supplements for Healthy Aging and Quality of Life: A natural multi-target approach for Alzheimer’s and age-related diseases”
  • “Crocin supplements are designed for … Alzheimer’s … Macular degeneration (AMD), diabetic maculopathy”
  • “[W]e identified crocin, the most important active constituent of saffron, as the best natural … anti-inflammatory agent .…”
  • “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.”

From the blog section of your webpage titled “Can Crocin Protect as an Antioxidant and Anti-inflammatory Agent Against Coronavirus (COVID-19)? A combination of the ancient wisdom of natural healing with current research.” (https://saffronhealthsci.com/blogs/general-knowledge/is-crocin-the-active-constituent-of-saffron-crocus-sativus-a-potential-antioxidant-and-anti-inflammation-agent-against-coronavirus-covid-19-a-combination-of-ancient-wisdom-in-natural-healing-with-current-research):

  • “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.”
  • “Published study results have revealed multi-target effects of crocin in modulating … inflammatory cytokines ….”
  • “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 ….”
  • “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.”
  • “Protective effects of crocin on the heart: … Crocin attenuates … inflammation, arrhythmias, injuries, and hemodynamic parameters from myocardial infraction and ischemic-reperfusion … [C]rocin is also revealed to attenuate myocardial fibrosis ….”
  • “A recent systemic review of meta-analysis of clinical evidence of saffron and crocin on cardiovascular risk factors has looked into 11 randomized clinical trials … Among these 11 trials of saffron and crocin, 6 evaluated effects of crocin (15-100mg/day) and demonstrate its significant effects on patients with Schizophrenia, diabetic macular edema, metabolic syndrome …, and coronary artery disease ….”

From the blog section of your webpage titled “Crocin as a Neuroprotective Agent Against Stroke.” (https://saffronhealthsci.com/blogs/general-knowledge/crocin-as-a-natural-neuroprotective-agent-forstroke):

  • “The neuroprotective effects of crocin against stroke is the focus of this article.”
  • “A number of studies have demonstrated that crocin provides neuroprotective … anti-inflammatory, edema suppressive, and brain injury protective effects ….”
  • “[C]rocin as a natural neuroprotective agent could help reduce risk of stroke and improve recovery.”

From the blog section of your webpage titled “Human Study Indicates Crocin Benefits Multiple Sclerosis Patients.” (https://saffronhealthsci.com/blogs/general-knowledge/human-study-indicates-crocin-benefits-multiple-sclerosis-patients):

  • “A 4-week double-blind, randomized, and placebo-controlled trial of crocin in multiple sclerosis patients … [resulted in the following] [h]ightlights of the study.”

    o “Findings revealed a significant decrease in the level of important pathogenic factors in MS, including lipid peroxidation, DNA damage, tumor necrosis factor-alpha (TNFa), and interleukin 17 (IL-17) … in the serum of patients treated with crocin (30mg/day) compared with the placebo group.”
    o “Treatment of crocin in MS patients provided protection against oxidative and inflammation damage biomarkers during the disease process.”
    o “The results suggest crocin as a promising therapeutic agent in prevention of progressive injury during MS.”

From the blog section of your webpage titled “Crocin Improves Sleep Quality and Removes Amyloid, Quality Sleep Washes Out Alzheimer’s Toxins and Amyloid.” (https://saffronhealthsci.com/blogs/generalknowledge/quality-sleep-washes-out-alzheimer-s-toxins-and-amyloid-natural-crocin-improves-sleepquality-and-removes-amyloid):

  • “[C]rocin was found significantly improved… depression, anxiety, … in patients … who were under Methadone maintenance treatment.”
  • “Crocin was found to prevent generation of toxic amyloid peptides through inhibiting two key enzymes in Alzheimer Disease Neuronal Cell Culture Models ….”
  • “[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.”

From the blog section of your webpage titled “Crocin and Saffron Are Good for Age-Related Eye Diseases.” (https://saffronhealthsci.com/blogs/general-knowledge/crocin-saffron-is-good-for-age-related-eye-diseases):

  • “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 (15 mg/day) significantly decreased central macula thickness and improved best corrected visual acuity (BCVA) or eyesight, in patients with diabetic macular edema after three months treatment. The crocin treatment also resulted in significant improvements in levels of fasting blood glucose and glycated haemoglobin A1c.”
  • “[C]rocin and saffron were also found to have inhibitory effects on cataract ....”

From the blog section of your webpage titled “How can Saffron and Crocin Help Depression?” (https://saffronhealthsci.com/blogs/general-knowledge/how-can-saffron-and-crocin-help-depression):

  • “[S]everal preclinical studies have confirmed the antidepressant effects of crocin. Crocin was also demonstrated in animal studies to improve anxiety and obsessive-compulsive disorder and reduce stress-induced anorexia ....”
  • “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.”
  • “Yet in another 8-week randomized double-blind controlled clinical study, saffron aqueous extract (30mg/day) and crocin (30mg/day) was compared against placebo on health-related quality of life, depression, and sexual desire in coronary artery disease patients. Both saffron and crocin significantly improved depression and quality of life in these patients with CAD ....”
  • “Crocin also significantly improved International Index of Erectile Functions ....”
  • “[C]urcumin [an ingredient in the Crocin Rich Plus product] was reported to have the potential to ameliorate depressive symptoms”

On your product webpage for Crocin Rich II (https://saffronhealthsci.com/products/crocin-rich-ii):

  • “CROCIN RICH II Is Good For … Help recovery of nerve and traumatic injury”

On your product webpage for Crocin Rich Plus (https://saffronhealthsci.com/products/crocin-rich-plus):

  • “CROCIN RICH plus Is Good For … Help recovery of nerve and traumatic injury”

From the section of your webpage titled “Crocin & Saffron News” (https://saffronhealthsci.com/pages/saffron-reseach-news):

  • “Crocin is … a potent … anti-inflammatory agent.”

Examples of claims observed on your Amazon product sales page for Crocin Rich (https://www.amazon.com/Crocin-Rich-Carotenoid-Combination-Zeaxanthin/dp/B01EDCRVKC):

  • “Ten (10) recent clinical studies reported crocin/saffron supplementation support visual acuity and eye functions in patients with AMD, diabetic retinopathy, and glaucoma.”
  • “Clinical findings indicate crocin/saffron supplementation is superior and provide markable eye health benefits in comparative studies to AREDS 2 formula.”

Examples of claims observed on your Amazon product sales page for Crocin Rich II (https://www.amazon.com/Crocin-Rich-II-Carotenoid-Strength/dp/B01EDCRW4W/ref=sr_1_2?dchild=1&m=A20ZTQB2YT4EN8&marketplaceID=ATVPDKIKX0DER&qid=1628895170&s=merchant-items&sr=1-2):

  • “Crocin Rich II is good for: … Help recovery of nerve and traumatic injury … Reduce hangovers”

Examples of claims observed on your Amazon product sales page for Crocin Rich Plus (https://www.amazon.com/Provides-Concentrated-Equivalent-Saffron-Antioxidants/dp/B01EDCRWU6/ref=sr_1_1?dchild=1&m=A20ZTQB2YT4EN8&marketplaceID=ATVPDKIKX0DER&qid=1628895736&s=merchant-items&sr=1-1):

  • “Crocin Rich plus is good for: … Help recovery of nerve and traumatic injury … Reduce Hangovers”

Examples of claims observed on your social media page at https://www.facebook.com/saffronhealthsci/:

  • Posted December 1, 2020: “Don't miss knowing the recent clinical findings of Crocin … on visual acuity and eye functions in patients with AMD, glaucoma, diabetic maculopathy, etc. https://saffronhealthsci.com/.../crocin-and-eye-health”
  • Posted September 27, 2020: “A natural approach with multi-target, neuroprotective, memory and cognition improving effects could offer a safe and effective alternative for Alzheimer’s disease. … https://saffronhealthsci.com/.../a-natural-composition...” Below this is a picture of the Crocin Rich Plus product with the caption “A Natural Composition with Multi-Target Neuroprotective Effects for Alzheimer’s.”
  • Posted June 23, 2020: “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. A combination of ancient wisdom of natural remedies with the latest scientific research may offer a promising approach to battle COVID-19 effectively. https://saffronhealthsci.com/.../is-crocin-the-active...” Below this is an image of a coronavirus with the caption “Can Crocin Protect as an …Anti-inflammatory Agent Against Coronavirus…”

Your Crocin Rich, Crocin Rich II and Crocin Rich Plus are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under Section 201(p) of the Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in Sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d), 355(a)]. FDA approves new drugs on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in Section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Crocin Rich, Crocin Rich II, and Crocin Rich Plus are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Crocin Rich, Crocin Rich II, and Crocin Rich Plus fail to bear adequate directions for their intended use and, therefore, the products are misbranded under 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates Section 301(a) of the Act [21 U.S.C. § 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to the following address: U.S. Food and Drug Administration, 11155 Dolfield Boulevard, Suite 117, Owings Mills, Maryland 21117. If you should have any questions regarding any issue in this letter, please contact Andrew J. Howard, Compliance Officer, at (410) 779-5125 or by email Andrew.Howard@fda.hhs.gov. Files greater than 100 megabytes may be submitted as smaller files in separate emails.

Sincerely,
/S/

Randy F. Pack
Program Division Director
Division Director
Human & Animal Food Division II East
Baltimore District Office

___________________________

1 There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. 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.

 
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