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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Birkdale Medicinals LLC 3/20/13

  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Sulie 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

 

 
WARNING LETTER
2013-DET-09
 
March 20, 2013
 
VIA UPS
 
 
Birkdale Medicinals LLC
Attention: Anthony Peters
250 N. Newman Road
Lake Orion, MI 48362
 
Dear Mr. Peters:
 
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://birkmeds.com in January 2013 and has determined that your products Immune Response 247, Cholestat, Silymarin 81, and LevelStat are promoted for conditions that cause the products to be 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)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. The marketing of these products with these claims violates the Act. You can find the Act and implementing regulations through links on FDA's Internet home page: http://www.fda.gov.
 
Examples of some of the claims observed on your website include:
 
Immune Response 247   
                                                                                     
  • “Studies have shown that medicinal mushrooms [an ingredient in your product] contain … properties that … offer help … individuals with cancer, asthma, and other chronic illnesses."
 
From an article entitled "The Health Benefits of Medicinal Mushrooms” accessed by clicking the link entitled “Articles” from the homepage:
 
  • “Here is a list of the key benefits associated with medicinal mushrooms [an ingredient in your product]:Reduces inflammation
  • Prevents the growth of tumor cells”
 
Your web site also contains disease claims in the form of personal testimonials for this product, including:
 
From the webpage “Read Stan Johnson’s Testimonial” accessible from a link on the Immune Response 247 product webpage:
 
  • “In 2000 I checked them (triglycerides) and they were 1625! … I began to do all the natural herbs and supplements to get them down coupled with exercise. The lowest I could get them down to was 350 … I found Immune Response 247 on the internet and after 30 days of use my triglycerides were down to 112!”
  • “If you have a cholesterol triglycerides problem give this [Immune Response 247] a try.”
 
Cholestat
 
  • “Cholestat contains scientifically-proven ingredients which work … to help control cholesterol build-up … preventing cholesterol transportation to the arteries, and reducing inflammation which increases plaque build-up.”
  • “Cholestat also … help[s] control oxidation of LDL and therefore reduce plaque formation on the arteries.”
 
Silymarin 81
 
  • The Silymarin in milk thistle has shown positive effects in treating many forms of liver ailments, including hepatitis, necroses, and cirrhosis”
 
LevelStat
 
From an article entitled “LevelStat Naturally Helps Maintain Normal Blood Sugar Levels” accessed by clicking the link entitled “For more information on LevelStat ingredients click here” located on the LevelStat product webpage:
 
  • “Studies have shown the antioxidant activity of ALA [Alpha Lipoic Acid, an ingredient in your product] … reduces cardiovascular complications of diabetes…slows down the effects of diabetic neuropathy cardiovascular complications of diabetes …”
  • “Bitter Melon has been used as an antidiabetic remedy …”
  • “[R]esearchers demonstrated the effect of cinnamon extract [an ingredient in your product] in a double-blind study. A significant reduction in fasting blood glucose levels was seen in patients with Type 2 diabetes. In addition to lowering blood sugar levels, a USDA study also showed cinnamon reduced cholesterol and decreased triglycerides in patients with Type 2 diabetes …”
  • “Supplementation with chromium [an ingredient in your product] in patients with a high‐risk of Type 2 diabetes (moderately obese and a family history of diabetes) was shown to reduce insulin resistance by 40 percent …”
 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the United States 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. The introduction of  unapproved new drugs into interstate commerce is a violation of section 301(d) of the Act [21 U.S.C. § 331(d)].
 
Furthermore, your products are misbranded within the meaning of section 502(f))(1) of the Act [21 U.S.C. § 352(f)(1)] in that they are 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 these drugs safely for their intended purposes. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. 
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.
 
Please send your reply to the attention of CDR Kimberly Martin, Compliance Officer, Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207-4291. If you have any questions regarding any issue in this letter, please contact CDR Martin at 317-226-6500 extension 116.
           
Sincerely,                                                                   
/S/ 
Glenn T. Bass
District Director
Detroit District Office