Inspections, Compliance, Enforcement, and Criminal Investigations

D&K Foods 9/15/16

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UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
BUREAU OF CONSUMER PROTECTION
WASHINGTON, D.C. 20580
DEPARTMENT OF HEALTH 
AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
SILVER SPRING, MD 20993

 

WARNING LETTER
SEPT 15, 2016 
 
VIA EXPRESS MAIL
 
Mr. Martin Silver
Side Effect Solutions Corporation dba NoBetes Corporation
13428 Maxella Ave
Suite 631
Marina del Rey, CA 90292
RE: 499092 
 
Dear Mr. Silver:                                                                                
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.nobetes.com in June 2016 and has determined that you take orders there for the product NoBetes. The claims on your website establish that this 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. In addition, the Federal Trade Commission reviewed your website for potential violations of Sections 5 and 12 of the FTC Act, 15 U.S.C §§ 45(a) and 52.
 
Your website contains numerous personal testimonials providing evidence that your product is intended for use as a drug. These testimonials recommend or describe the use of NoBetes for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
On your home page, in a YouTube video titled “NoBetes Commercial”:
  • “I’m a type 1 diabetic meaning I’m insulin dependent… when I started taking NoBetes my blood sugar levels were up to 285… after only 1 day of taking NoBetes, my blood sugar dropped to 115.” (00:58 – 1:09)
  • “I used to be a 240, now it’s at 161, this is less than a week. [N]oBetes something you should definitely look into if you’re a type 2 diabetic.” (01:35 – 01:49)
  • “NoBetes took me from 280 to 130 within a week.” (01:58 – 02:03)
  • “I’m a type 1 diabetic and I start taking NoBetes and I notice right when I took NoBetes, the numbers dropped down shortly … My numbers were 400 … and now it’s 125.” (02:36 – 03:05)
  • “I went down from 549 on blood sugar count to 88 and a half with using NoBetes, an all-natural supplement. I can tell you it’s worked better than any prescribed medicine I’ve taken.” (03:08 – 03:21)
  • “My sugar levels were 227 to 85 in less than 10 days. At nighttime I had tingling in my arms, and dry mouth, and even blurry vision. This has all gone away just by taking a pill, NoBetes is a natural product...I got off my other medications” (03:36 – 04:01)
  • “Are you a diabetic with blood sugar that ranges from 200 to 550 or more? … Attack the problem now and naturally with NoBetes, a natural supplement” (05:18 – 05:37)
  • “My blood sugar had gotten itself up there to 9.5 on the A1C so again I went back to 3 pills a day, backed off a little on the candy, not a lot, little little. And I’m down to 6.2 now.” (09:12 – 09:29)
  • “I dropped my A1C from the high 7s to low 6s” (13:19 – 13:22) 
Some of these claims are repeated in your other videos titled, “Bob Corder – Blood Sugar Went from 549 to 88.5 – NoBetes Testimonial,” “Eddie J’s Blood Sugar Goes From 280 to 130 in 5 to 7 Days – NoBetes Testimonial,” “Lance Tepper – Blood Sugar Went From 225 to 85 in 1 week – NoBetes Testimonial,” and “Kyrsten’s Blood Sugar Goes 285 to 115.”
 
 On the “Testimonials” page:
  • “I’m a type 2 diabetic and my blood sugar was 225 and in less than a week it went down to 85, but I had to take 4 pills.”
  • “I was at 549 and now I’m down to 88 and a half.”
  • “I would highly recommend this great product to anybody that has diabetes type 2. As of a week after taking the NoBetes my blood sugar came down to the 2 digit reading. When I first started taking it it was 198. Now my blood readings are no higher than 120.”
  • “I’m a type 1 diabetic. When taking NoBetes, my blood sugar dropped from 295 to 115 in just 1 day. And when I take NoBetes, my blood sugar levels remain stable and I feel great.”
  • “NoBetes, my number went from 280 down to 130 within 5 to 7 days.”
  • “My blood sugar dropped from 378 to 198 in two weeks.”
  • “My blood sugar dropped from 420 to 180 in 2 days while using NoBetes”
Moreover, claims made on your Facebook page, https://www.facebook.com/NoBetes-129088870556782, which has links to your website at https://www.nobetes.com, where your product can be purchased directly, provide further evidence that your product is intended for use as a drug.
 
On the “Timeline” section of your Facebook page you provide links to several YouTube videos that are also embedded on your website https://www.nobetes.com:
  • “Bob Corder – Blood Sugar Went from 549 to 88.5 – NoBetes Testimonial”
  • “Kyrsten’s Blood Sugar Goes 285 to 115”
  • “Eddie J’s Blood Sugar Goes From 280 to 130 in 5 to 7 Days – NoBetes Testimonial” 
On the “About” section of your Facebook page:
  • “NoBetes … is designed to help manage diabetics side effects. This product also contains natural ingredients that have been shown in studies to help your body’s ability to control blood sugar levels”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” 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 (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 product NoBetes is intended for treatment of one or more diseases that are not amenable to self-diagnosis and 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, NoBetes 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)].
 
Unsubstantiated Advertising
 
In addition, 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 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.  See POM Wonderful LLC v. FTC, 777 F.3d 478, 504-05 (D.C. Cir. 2015), reh’g denied, 2015 U.S. App. LEXIS 8946 (D.C. Cir. 2015) (en banc); 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 In re Daniel Chapter One, No. 9239, 2009 WL 516000 at *17-19 (F.T.C. Dec. 24, 2009), aff'd, 405 Fed. Appx. 505 (D.C. Cir. 2010).
 
The FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence.  Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order.  An order also may require that you pay back money to consumers.
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your product. 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 and 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/or injunction. 
 
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. If you have any questions regarding compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088. With regard to the FDA-related violations described in this letter, please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen working days, please explain the reason for the delay and state the date by which you will make the correction.
 
If you need additional information or have questions concerning any products distributed through your website, please contact FDA. You may respond in writing to Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, College Park, MD 20740, Attention: Anam Drumheller. If you have any questions concerning this letter, please contact Anam Drumheller at 240-402-1563.
 
Sincerely,
/S/ 
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission 
 
/S/                                              
William A. Correll
Director
Office of Compliance
Center for Food Safety
And Applied Nutrition
Food and Drug Administration
 
 
cc:
NoBetes Corporation
Attn: Jeffrey Fleitman
424 South Beverly Drive
Beverly Hills, CA 90212

 

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