WARNING LETTER
Nuturna International LLC
MARCS-CMS 614577 —
September 07, 2021
Delivery Method:
Via Overnight Delivery
Product:
Dietary Supplements
Recipient:
Recipient Name
John Shields
Nuturna International LLC
390 North Orange Ave. Suite 2300
Orlando
,
FL
32801
United States
corporate@nuturna.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Federal Trade Commission
WARNING LETTER
RE: 614577
Dear Mr. John Shields:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at https://nuturna.com/ in August 2021 and has determined that you take orders there for your “Diabetic Support Formula” product. Additionally, we reviewed your product listing and your seller profile on your Amazon storefront on www.amazon.com, which you operate under the name, “Nuturna International.” You are also advised that the Federal Trade Commission reviewed your websites in August 2021.
The claims on your website and Amazon product page establish that your product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product 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.
Your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of “Diabetic Support Formula” for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
• “I have struggled for 7 years to have a normal A1C, until now. Before buying the Nuturna diabetic support I was taking 3 different supplements along with Metformin to help control my glucose levels …”
• “So far I have been taking the Nuturna support for 4 years and it gives me everything I need, plus extras to lower my sugar levels …”
• “I have been taking Nuturna Diabetic Support Supplement for more than 4 years. It has kept my blood sugar readings within a normal range …”
• “I started taking these less than 30 days ago after a visit to my doctor who recommended I use it for the blood sugar support but also because it is the only diabetic support with a complete multivitamin. took as directed. went to the doctor today and a1c was great …”
On your Amazon.com product page for “Diabetic Support Formula”:
• “Support for Lower Blood Sugar Levels”
• “Created by Diabetics for Diabetics…”
• “
Important Diabetic News
…According to a clinical trial published in the
Renowned American College of Physicians[…]Objective:
To determine the effect of a Powerful- Strength multivitamin and mineral supplement on infections and well-being in type 2 diabetics. […]
Result:
Taking a
high-quality vitamin and mineral supplement
every day dramatically reduces the incidence of infection and the number of sick days taken by patients with type 2 diabetes[…]
Taking Nuturna Is Like Taking a Flu Shoot
[sic]... Carefully Formulated to Help You Today and Tomorrow... It's WORKING Even If YOU Can't See It....Just Like A Flu Shoot [sic]...
Trusted By Diabetics Since 2009
”
Your Amazon.com product page also contains evidence of intended use in the form of personal testimonials recommending or describing the use of “Diabetic Support Formula” for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
• “I have struggled for 7 years to have a normal A1C, until now. Before buying the Nuturna diabetic support I was taking 3 different supplements along with Metformin to help control my glucose levels …”
• “So far I have been taking the Nuturna support for 4 years and it gives me everything I need, plus extras to lower my sugar levels …”
• “I have been taking Nuturna Diabetic Support Supplement for more than 4 years. It has kept my blood sugar readings within a normal range …”
Your “Diabetic Support Formula” product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 C.F.R. 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 product “Diabetic Support Formula” is intended for treatment of one or more diseases that, with certain exceptions not applicable here, 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 product safely for its intended purposes. Accordingly, your “Diabetic Support Formula” product fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug 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 reply to the above violations should be directed to Aaron Dotson with the FDA via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.
FTC Cease and Desist Demand:
In addition, the Federal Trade Commission has determined that it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess a reasonable basis consisting of competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. POM Wonderful LLC, 155 F.T.C. 1, 60-61, (2013), aff’d in relevant part, 777 F.3d 478 (D.C. Cir. 2015); Daniel Chapter One, FTC Dkt. No. 9239, 2009 WL 5160000 at *16-19 (F.T.C. Dec. 24, 2009), aff’d, 405 Fed. Appx.505 (D.C. Cir. 2010); Removatron Int'l Corp., 111 F.T.C. 206, 297-99 (1988), aff’d, 884 F.2d 1489, 1496 (1st Cir. 1989); see also, FTC v. Direct Mktg. Concepts, 569 F. Supp. 2d 285, 300, 303 (D. Mass. 2008), aff’d, 624 F.3d 1 (1st Cir. 2010); FTC v. Nat'l Urological Group, Inc., 645 F. Supp. 2d 1167, 1190, 1202 (N.D. Ga. 2008), aff’d, 356 Fed. Appx. 358 (11th Cir. 2009); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 2007-2 Trade Cas. (CCH) P75,866, 2007 U.S. Dist. LEXIS 60783, at *11-12 (C.D. Cal. Aug. 7, 2007). More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See Daniel Chapter One, WL 5160000 at *17-19.
The FTC is concerned that one or more of the efficacy claims cited above may not be substantiated by competent and reliable scientific evidence. Notice is hereby given that you must cease and desist from making any claim that a product and prevent, treat, or cure diabetes without competent and reliable scientific evidence consisting of well-controlled human clinical studies substantiating that the claims are true. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. In addition, marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of a disease may be subject to a civil penalty of up to $43,792 per violation pursuant to Section 5(m)(1)(B) of the FTC Act, 15 U.S.C. § 45(m)(1)(B), and may be required to pay refunds to consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b). With regard to the advertising claims discussed above, please notify Richard Cleland of the FTC via electronic mail at rcleland@ftc.gov within fifteen (15) working days of receipt of this letter of the specific actions you have taken to address FTC's concerns.
Sincerely,
/S/
Glenn Bass
Acting Deputy
Director Office of
Compliance
Center for Food Safety
and Applied Nutrition
Food and Drug Administration
Sincerely,
/S/
Serena Viswanathan
Associate Director
Division of Advertising Practices
Federal Trade Commission
Content current as of:
09/09/2021
Regulated Product(s)
Dietary Supplements