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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Glytain 7/15/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770 

 

VIA UPS
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-13-25
July 15, 2013
 
Mr. Greg Grant
Internal Remedies, Inc. dba Glytain
5620 Dewey St.
Hollywood, FL 33023
 
Cc:      Glytain
           14359 Miramar Pkwy., Suite 118
           Miramar, FL 33027
 
Dear Mr. Grant:
 
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.glytain.com in January 2013 and has determined that your product “Glytain” is being promoted for the prevention and treatment of diabetes. The label of “Glytain” makes similar claims that the product is useful in preventing and treating diabetes. The claims on your product label and your website establish that this product is a drug as defined in 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. The marketing of your product with these claims violates the Act. You can find the Act and implementing regulations through links on FDA’s Internet home page at http://www.fda.gov.
 
Examples of the claims on your “Glytain” product label include the following:
 
  • “Control your Diabetes Naturally”
  • “Glytain is an all natural treatment for diabetes that…can help to naturally reduce blood sugar levels.”
  • “Glytain is effective because it works naturally affecting the body at a cellular level to reduce insulin resistance and assist glucose regulation.”
  • “In addition to combating high blood sugar levels, Glytain is also a natural source of antioxidants, detoxifiers, hormone modifiers, and cell regulators.”
 
Examples of the claims on your www.glytain.com website include the following:
 
On the home page, under “Natural treatment for Type 1 Diabetes, Type 2 Diabetes, and Pre-Diabetes”:
 
  • “Glytain is an all natural dietary supplement that works with your body to lower your blood sugar naturally.”
 
Claims for ingredients and nutrients in Glytain on the home page, under “Natural ingredients are used to lower blood sugar”:
 
  • “The ingredients in Glytain have been used for thousands of years and have also proven to be effective on lowering blood sugar levels in numerous clinical studies.”
  • “Vitamins B1, 2, 3 {lowers cholesterol, lowers dangerous effects of high blood sugar]”
  • “Vitamin B12 – works with folic acid to reduce the risk of stroke and cancer”
  • “Potassium – to prevent impaired glucose tolerance and insulin secretion”
 
On the home page, under “Naturally control and maintain your blood glucose levels”:
 
  • “Glytain is effective because it works naturally affecting the body at a cellular level to reduce insulin resistance and assist with glucose regulation.”
 
On the webpage titled, “Type 2 Diabetes”
 
  • “[I]f you start now and help your body by taking Glytain…you have an [sic] very good chance at avoiding the possibility of your Type 2 Diabetes progressing into Type 1 Diabetes.”
 
On the webpage titled, “Type 1 Diabetes”
 
§ “The main for for [sic] people with Type 1 Diabetes is to keep their blood sugar level/blood glucose level as close to normal as possible. Glytain can help with this and make it easier for you to manage with the form of diabetes.”
 
Under the tab “FAQ”:
 
  • “Within the first 10-14 days of starting Glytain you notice a drop in your blood sugar levels, and by the end of the first 30 days you will notice a significant drop in your blood sugar levels.”
  • [B]oth Type 1 and Type 2 customers have achieved great success while taking Glytain.”
  • “Glytain can help you drop your blood sugar level as much as 60 points.”
  • “While most people see substantial drops in their blood sugar levels within the first month, we recommend following our program for a minimum period of 4-6 months in order to give your pancreas and body a good chance to recover…”
 
Under the tab “Testimonials”:
 
  • “[I] looked over the proof they offer in the clinical studies showing that their ingredients are proved to be effective so I decided to give this company a try. To my surprise (and relief) the Glytain actually worked and lowered my blood sugar levels an average of 54 points.”
  • “For years my blood sugar was in the 190-200 point range, after taking your product it is now averaging in the 140-155 point range.”
 
Moreover, when scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of publications that are used to market your product for diabetes treatment and prevention on your website and are thus evidence of your product’s intended use as a drug:
 
  • Frani-Munari AC., et al., Hypoglycemic action of different doses of nopal (Opuntia streptacantha Lemaire) in patients with type II diabetes mellitus. Arch Invest Med (Mex) 1989 Apr-Jun;20(2):197-201.
  • Román-Ramos R., et al., Experimental study of the hypoglycemic effect of some anti-diabetic plants. Arch Invest Med (Mex). 1991 Jan-Mar;22(1):87-93. 
  • Meckes-Lozyoa M., et al., Opuntia streptacantha: a coadjutor in the treatment of diabetes mellitus. Am J Chin Med. 1986;14(3-4):116-8.
 
The claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches. Examples of metatags targeted to consumers who are looking for products to prevent or treat diabetes include “Natural diabetes treatment,” “alternative diabetes treatment,” “lower blood sugar,” and “lower blood glucose, Type 1 Diabetes, Type 2 Diabetes, and juvenile diabetes.”
 
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 marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
Furthermore, your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, your product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of 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 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 assure that your firm complies with all requirements of federal law and 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 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 working days, state the reason for the delay and the time within which you will complete the correction.
 
Please send your reply to the attention of Andrea H. Norwood, Compliance Officer, Food and Drug Administration, Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding this letter, please contact Ms. Norwood at 407-475-24.
                                                           
Sincerely,
/S/ 
Emma R. Singleton
Director, Florida District