WARNING LETTER
Reddy Naturals
MARCS-CMS 609906 —
December 18, 2020
Delivery Method:
United Parcel Service
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Nagari K. Reddy
Recipient Title
Owner
Reddy Naturals
1300 Cobb International Dr. NW Suite A
Kennesaw
,
GA
30152
United States
Issuing Office:
Division of Human and Animal Food Operations East III
United States
December 18, 2020
Reference: CMS Case 609906
WARNING LETTER
Dear Mr. Reddy:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.reddynaturals.com in December 2020 and has determined that you take orders there for the products “Glycostasis,” “Glucosamine Curcumin,” “Turmeric 50,” “Turmeric Curcumin,” “Cetyl Curcumin,” “Ashwagandha,” “Huruli,” “Black Seed Oil,” “Curcumin Turmerone,” and “Ashwagandha Honey.” We have also reviewed your social media website at www.facebook.com/ReddyNaturals; this website directs consumers to your website www.reddynaturals.com to purchase your products. The claims on your 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. 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:
On your product webpage for “
Glycostasis
” (https://reddynaturals.com/product/glycostasis/):
• “Reddy Naturals Glycostasis aids in reducing blood sugar levels and so much more.”
• Tags: “anti-inflammatory . . . body pain, . . . inflammation, joint pain, . . . pain . . .”
• “Anti-Inflammatory”
• “Reduces joint pain, swelling, and fatigue”
• “Helps reduces [sic] likelihood of and treats Alzheimer’s”
• “Reduces Heart disease risk”
• “Anti-fungal, Anti-viral, and Anti-bacterial”
On your product webpage for “
Glucosamine Curcumin
” (https://reddynaturals.com/product/glucosamine-curcumin/):
• “Reddy Naturals … Glucosamine Curcumin …- Natural Anti Inflammatory … Reduces Joint, Body Pain….”
• Tags: “anti-inflammatory, body pain, . . . inflammation, joint pain, . . . pain . . .”
• “Anti-Inflammatory”
• “Reduces joint pain, swelling, and fatigue”
• “Helps reduces [sic] likelihood of and treats Alzheimer’s”
• “Reduces Heart disease risk”
• “Anti-fungal, Anti-viral, and Anti-bacterial”
On your product webpage for “
Turmeric Curcumin
” (https://reddynaturals.com/product/turmeric_curcumin/):
• “Our honey flavored Reddy Naturals Turmeric Curcumin with black pepper aids in reducing inflammation, joint and body pains, ….”
• “Anti-Inflammatory”
• “Reduces joint pain, swelling, and fatigue”
• “Helps reduces [sic] likelihood of and treats Alzheimer’s”
• “Reduces Heart disease risk”
• “Anti-fungal, Anti-viral, and Anti-bacterial”
On your product webpage for “
Cetyl Curcumin
” (https://reddynaturals.com/product/cetyl-curcumin/):
• “Reddy Naturals Cetyl Curcumin is an all natural anti-inflammatory sweet supplement that helps offer relief for joint and body pains.”
• Tags: “anti-inflammatory, body pain, . . . inflammation, joint pain, . . . pain . . .”
• “Anti-Inflammatory”
• “Helps relieve rheumatoid arthritis acting as a joint lubricant.”
• “Reduces joint pain, swelling, and fatigue”
• “Anti-fungal, Anti-viral, and Anti-bacterial”
• “Cetyl is known to help relieve reheumatiod [sic] arthritis symptoms by acting as a joint lubricant and anti-inflammatory agent. Curcumin also works great as an anti-inflammatory and for joint and body pains.”
On your product webpage for “
Curcumin Turmerone
” (https://reddynaturals.com/product/curcumin-turmerone/):
• “Reddy Naturals Curcumin Turmerone aids in reducing inflammation, joint and body pains, and so much more.”
• Tags: “anti-inflammatory, body pain, . . . inflammation, joint pain, . . . pain . . .”
• “Anti-Inflammatory”
• “Reduces joint pain, swelling, and fatigue”
• “Helps reduces [sic] likelihood of and treats Alzheimer’s”
• “Reduces Heart disease risk”
• “Anti-fungal, Anti-viral, and Anti-bacterial”
On your product webpage for “
Turmeric 50
” (https://reddynaturals.com/product/turmeric_curcumin_50/):
• “This one bottle will give you health benefits to…reduce allergies, reduce pain & inflammation, and so much more!”
• Tags: “allergies, . . . inflammation, joint pain, pain”
• “Anti-Inflammatory”
• “Reduces joint pain, swelling, and fatigue”
• “Helps reduces [sic] likelihood of and treats Alzheimer’s”
• “Reduces Heart disease risk”
• “Anti-fungal, Anti-viral, and Anti-bacterial”
On your product webpage for “
Ashwagandha
” (https://reddynaturals.com/product/ashwagandha):
• “Relieves . . . depression . . .”
• “Stabilizes blood sugar”
• “Lowers cholesterol levels”
• “Provides relief from inflammation and pain”
• “Effective in controlling bacterial infections”
• “Reduces brain cell degeneration”
On your product webpage for “
Ashwagandha Honey
” (https://reddynaturals.com/product/ashwagandha-honey/):
• “Relieves . . . depression . . .”
• “Stabilizes blood sugar”
• “Lowers cholesterol levels”
• “Provides relief from inflammation and pain”
• “Effective in controlling bacterial infections”
• “Reduces brain cell degeneration”
On your product webpage for “
Huruli
” (https://reddynaturals.com/product/huruli/):
• “Helps reduce blood glucose level”
• “Helps to expel small kidney stones”
• “Relieves common cold, cough, fever, bronchitis, and asthma”
• “Cures indigestion and relieves constipation”
On your product webpage for “
Black Seed Oil
” (https://reddynaturals.com/product/organic_blackseed_oil/):
• “Fights fungal infections – has anti-fungal and anti-bacterial properties”
• “Works great as a . . . sunscreen
• “Reduces allergies/sinus infections due to strong anti-bacterial and anti-inflammatory properties”
• “Reduces flu, fever, cough, and asthma”
• “Cures boils”
• “Helps reduce high blood pressure”
• “May aid in rheumatoid arthritis”
• “May help reduce blood sugar and cholesterol levels”
Claims displayed on your Facebook website www.facebook.com/ReddyNaturals:
April 22 Facebook post (which links to product webpage for “
Turmeric Curcumin
”):
• “SURPRISING BENEFITS OF TURMERIC”
• “ANTI-INFLAMMATORY - The Pigment in turmeric comes from curcumin, and curcumin is a powerful anti-inflammatory comparable even to prescribed pain medication or NSAIDs.”
• “HEART DISEASE & CHOLESTEROL - Curcumin works in a number of different ways to help with heart disease. It works as an antioxidant to prevent the oxidation of LDL cholesterol and increases LDL receptors to give LDL cholesterol more places to go and do its job, preventing it from spending too long in our bloodstream and oxidizing.”
• “ARTHRITIS -A recent study showed that the effects of curcumin on rheumatoid arthritis were comparable to those of a medical anti-inflammatory when dealing with morning stiffness and joint swelling.”
May 4 Facebook post (which links to product webpage for “
Ashwagandha Honey
”):
• “8 HEALTHY BENEFITS OF ASHWAGANDHA”
• “Combats neurodegenerative diseases - Protective effects against B-amyloid-induced plaques in Alzheimer’s Disease.”
• Stabilises [sic] blood sugar - Stabilise [sic] blood sugar levels, reducing blood sugar when it’s too high or increasing it if too low.”
• “It is also helpful for . . . those with fatigue-related conditions.”
• “[A]nti-inflammatory”
• “Ashwagandha may mitigate memory and brain function problems caused by injury or disease.”
July 2 Facebook post for “
Glucosamine Curcumin
”:
• “Glucosamine Curcumin from ReddyNaturals helps relieve joint and knee pain associated with osteoarthritis. It helps protect against cartilage deterioration, ease pain, …. #inflammation #sore #bodypains … #antiviral”
• “Anti-Inflammatory”
• “Reduces Joint Pain & Swelling”
• “Antimicrobial”
July 13 Facebook post for “
Cetyl Curcumin
”:
• “Anti-Inflammatory”
• “Reduces Joint Pain & Swelling”
• “Antimicrobial”
September 18 Facebook post for “
Turmeric 50
”:
• “Reduces Joint & Body Pains”
• “Anti-inflammatory”
Your “Glycostasis,” “Glucosamine Curcumin,” “Turmeric 50,” “Turmeric Curcumin,” “Cetyl Curcumin,” “Ashwagandha,” “Huruli,” “Black Seed Oil,” “Curcumin Turmerone,” and “Ashwagandha Honey” 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)]. 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. (See 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 products, “Glycostasis,” “Glucosamine Curcumin,” “Turmeric 50,” “Turmeric Curcumin,” “Cetyl Curcumin,” “Ashwagandha,” “Huruli,” “Black Seed Oil,” “Curcumin Turmerone,” and “Ashwagandha Honey” 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, “Glycostasis,” “Glucosamine Curcumin,” “Turmeric 50,” “Turmeric Curcumin,” “Cetyl Curcumin,” “Ashwagandha,” “Huruli,” “Black Seed Oil,” “Curcumin Turmerone,” and “Ashwagandha Honey” 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)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
If you have questions regarding the content of this letter you may contact Patricia F. Hudson, Compliance Officer at
(404) 253-2221
, or via email at patricia.hudson@fda.hhs.gov.
Sincerely,
/S/
Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Foods Operations-East 3
Content current as of:
01/05/2021
Regulated Product(s)
Drugs
Food & Beverages