WARNING LETTER
Saffron USA LLC
MARCS-CMS 629821 —
September 23, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
17-HAFE4-WL-07
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Farangis Sedaghat
Recipient Title
Manager
Saffron USA LLC
504 Spring Island Way
Orlando
,
FL
32828
United States
ftsedaghat@yahoo.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
WARNING LETTER
September 23, 2022
Dear Ms. Sedaghat:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at https://saffronusa.com in September 2022 and has determined that you take orders there for the products Allergy Blend, Chamomile Tea Petals, Diabetic Support Blend, Orange Blast Tea, and Saffron Loose Tea. The claims on your website establish that these 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. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
1. Product: Allergy Blend
On your product website https://saffronusa.com for Allergy Blend and under Health Benefits, your webpage shows:
- Product name “Allergy Blend”
- “A natural blend for Allergy relief”
- “Upper respiratory tract infections”
- “Coughs, Bronchitis”
- “Asthma”
2. Product: Chamomile Tea Petals
On your product website https://saffronusa.com for Chamomile Tea Petals under Health Benefits, your webpage shows:
- “Treating diabetes”
- “Slowing or preventing osteoporosis”
- “Reducing inflammation”
- “Cancer”
- “[T]reating cold symptoms”
3. Product: Diabetic Support Blend
On your product website https://saffronusa.com for Diabetic Support Blend and under Health Benefits, your webpage shows:
- Product name “Diabetic Support Blend”
- “A natural blend to help combat Diabetic”
- “Have Cancer-Fighting Properties”
- “Decrease Cholesterol Levels…”
4. Product: Orange Blast Tea
On your product website https://saffronusa.com for Orange Blast Tea under Health Benefits, your webpage shows:
- “Prevents skin damage.”
- “Keeps blood pressure under check.”
- “Lowers cholesterol.”
- “Controls blood sugar level.”
- “Lowers the risk of cancer.”
5. Product: “Saffron Loose Tea”
On your product website https://saffronusa.com for Saffron Loose Tea under Health Benefits, your webpage shows:
- “Fights Anxiety”
- “Cancer prevention”
- “Help insomnia”
Your Allergy Blend, Chamomile Tea Petals, Diabetic Support Blend, Orange Blast Tea, and Saffron Loose Tea products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 a new drug 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 Allergy Blend, Chamomile Tea Petals, Diabetic Support Blend, Orange Blast Tea, and Saffron Loose Tea products are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, 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, your Allergy Blend, Chamomile Tea Petals, Diabetic Support Blend, Orange Blast Tea, and Saffron Loose Tea products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 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. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. 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 corrective actions within 15 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 directed to the Food and Drug Administration, attention to: Mr. Ramon A. Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. You may email a copy of your response with appropriate attachments to email address: orahafeast4firmresponses@fda.hhs.gov . Please ensure your firm name, Firm Establishment Identifier (FEI) and establishment address are included in the correspondence. If you have any questions regarding this letter, please contact Ms. Gina Eng, Compliance Officer, at (561) 416-1065 ext. 1114 or via email at Gina.Eng@fda.hhs.gov.
Sincerely,
/S/
Ramon A. Hernandez
District Director | FDA San Juan District
Program Division Director
Office of Human and Animal Food
Operations
East Division 4
Content current as of:
12/06/2022
Regulated Product(s)
Food & Beverages