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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ad-Med Biotechnology, LLC 8/12/14

  

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

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

 

WARNING LETTER
2014-DET-15
 
August 12, 2014
 
 
VIA UPS
 
Mr. Frederic J. Jouhet
President and CEO
Ad-Med Biotechnology, LLC
A.M.S. Bioteck, LLC
280 N. Old Woodward Avenue, Suite 107
Birmingham, MI 48009
 
Dear Mr. Jouhet:
 
The U.S. Food and Drug Administration (FDA) reviewed the label for your “Immune Active Adult Formula” product.  In addition, the FDA reviewed your websites at www.immuneactive.com, www.admedbiotech, www.amsbiotek.com and www.mkactive.com in June 2014. Your websites at www.admedbiotech.com and www.mkactive.com contain links to your www.immuneactive.com website, which automatically redirects to your website at www.amsbiotek.com where “Immune Active Adult Formula” and “Immune Active Children’s Formula” can be purchased directly.  We have determined that your websites and the product label for your “Immune Active Adult Formula” product promote your “Immune Active Adult Formula” and “Immune Active Children’s Formula” products for conditions that cause the products to be drugs within the meaning of 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 websites and product label for your “Immune Active Adult Formula” establish that the products are drugs 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.
 
Further, “Immune Active Adult Formula” and “Immune Active Children’s Formula” are misbranded under section 403 of the Act [21 U.S.C. § 343] as explained below.
You can find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
Unapproved New Drugs
 
Examples of some of the claims on your product label that provide evidence that your product “Immune Active Adult Formula” is intended for use as a drug include:
 
  • “Joint Pain Relief & Inflammatory Disorders…Compound FJ1 [an ingredient in your product] inhibits inflammatory mediators TNF-A, IL-1 beta and IL-10. These mediators promote inflammatory response associated with rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, plaque psoriasis and asthma.”
  • “Compound FJ1 is clinically shown to be a power antiviral, antibacterial and antifungal.”
  • “Anti Microbial”
 
Examples of some of the website claims that provide evidence that your products “Immune Active Adult Formula” and “Immune Active Children’s Formula” are intended for use as drugs include:
 
On the website www.amsbiotek.com, under the “our Online Store” link (from the downloadable “Immune Active” brochure)
 
  • “Components in Compound FJ1 fight numerous virus infections.”
 
“Laboratory studies have proven the efficacy against viral infections due to herpes virus ( HPV, HSV) and influenza virus (including H1N1, H5N1 and subtypes).”
 
“[C]ompound FJ1 has in vitro and in vivo efficacy for both the prevention, as well as, the treatment of Dengue Fever on Rhesus Macaque Monkeys.”
 
  • “Independent tests indicate that Terpinen-4-ol, the predominate active component of Compound FJ-1, inhibits the inflammatory mediators; tumor necrosis factor alpha (TNF-A), IL-1 Beta, and IL-10. These inflammatory mediators, if left unchecked can cause inflammatory responses associated with many autoimmune disorders.”
  • “ANTI MICROBIAL”
  • “We have indentified the components compounds and quantified the antibacterial and antifungal activities against a number of common microbial pathogens such as Bacillus Agtrophaeus, Legionella, Listeria, Salmonella and several types of Stapylococcus.”
 
On the website www.amsbiotek.com, under the “Science” link
 
  • “The Science…[t]he table below shows the test results for the determination of the minimum inhibitory concentrations (MIC) between standard TTO and Compound FJ1 against a number of common bacteria and fungi.”
 
 
Strain
Tween 60
MP10/190 complete
CFJ1
Actinomyces naeslundii
Growth
2,5%
1,25%
Bacillus atrophaeus
Growth
0,31%
0,16%
Bacillus cereus
Growth
0,31%
0,31%
Clostridium perfringens
Growth
-
-
Escherichia coli
Growth
0,31%
0,16%
Fusobacterium nucleatum
Growth
0,31%
0,635%
Legionella pneumophila
Growth
-
1,25%
Listeria monocytogenes
Growth
0,6355
0,31%
Propionibacterium acnes
Growth
2.50%
1.25%
Pseudomonas aeruginosa
Growth
1,25%
2,5%
Salmonella enterica serovar typhimurium
Growth
0,04%
0,04%
Staphylococcus aureus
Growth
0,31%
0,16%
Staphylococcus epidermis
Growth
0,31%
0,16%
Streptococcus mutans
Growth
0,31%
2,5%
Streptococcus oralis
Growth
0,635%
0,16%
Veillonella dispar
Growth
1,25%
1,25%
Vibrio splendidus
Growth
2,5%
2,5%
Vibrio cholera
Growth
0,08%
0,08%
Yersinia enterolytica
Growth
0,08%
0,04%
Aspergillus niger
Growth
0,31%
0,635%
Candida albicans
Growth
1,25%
1,25%
Malassesia furfur
Growth
1,25%
0,635%
 
 
  • “The process of refining crude TTO and transforming it into Compound FJ1 actually increases its efficacy against many harmful human pathogens.”
 
On the website www.amsbiotek.com, under the “Science” link and sub-link “Anti-Inflammatory”
 
  • “While controlled inflammation is normally beneficial, in excess it can be harmful. It has been implicated in the spread and proliferation of cancer, obesity, diabetes, atherosclerosis, and a many other chronic diseases. Compound FJ1 works in concert with numerous biochemical pathways responsible for inhibiting and reducing inflammation. Independent tests indicate that Terpinen-4-ol, the predominate active component of Compound FJ-1, inhibits the inflammatory mediators; tumor necrosis factor alpha (TNF-A), IL-1 Beta, and IL-10. Theses inflammatory mediators, if left unchecked can cause inflammatory responses associated with autoimmune disorders such as rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, plaque psoriasis and asthma. In comparison, pharmaceutical drugs such as Enbrel, Humira, and Remecade also suppress tumor necrosis factor. However, the acknowledged side effects include reduced immune system, cancer and possible death.”
 
On the websites www.admedbiotech.com and www.mkactive.com
 
  • “Our premier offering, “IMMUNE ACTIVE”, is an immune system boosting supplement based on our scientifically developed Compund FJ1. Compound FJ1 is a proprietary derivative of Tea Tree Oil…possesses anti-inflammatory, anti-bacterial, anti-fungal and anti-viral capabilities.”
 
Your 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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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. 
 
Further, your products “Immune Active Adult Formula” and “Immune Active Children’s Formula” 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. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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)].
 
Misbranded Dietary Supplements
 
Even if your products “Immune Active Adult Formula” and “Immune Active Children’s Formula” were not unapproved new drugs, they would still be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343].
 
Your “Immune Active Adult Formula” and “Immune Active Children’s Formula” products are misbranded within the meaning of section 403(a)(1) of the Act, [21 U.S.C. § 343(a)(1)], because your product label for “Immune Active Adult Formula” and your website at www.amsbiotek.com, under the “Science” link, “Immune Active Supplement Facts” for “Immune Active Children’s Formula” state the following:
 
  • "Melaleuca Alternifolia is FDA GRAS-designated as safe.”
 
This statement is false or misleading because FDA has not designated Melaleuca Alternifolia as generally recognized as safe (GRAS). FDA regulates the use of Melaleuca leucadendron L. and other Melaleuca species as food additives under 21 CFR 172.510.  The use of Melaleuca Alternifolia in your product does not fall under this regulation.  21 CFR 172.510 is limited to food additives that are natural flavoring substances and natural substances used in conjunction with flavors.  Your use of Melaleuca Alternifolia as a dietary ingredient under section 201(ff)(1) of the Act, [21 U.S.C. § 321(ff)(1)],  is not covered by 21 CFR 172.510.  Therefore, the labeling for your “Immune Active Adult Formula” and “Immune Active Children’s Formula” dietary supplement products is false and misleading.
 
Your "Immune Active Adult Formula” dietary supplement product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. 403(s)(2)(B)] because the label fails to identify the products using the term “dietary supplement” as required by 21 CFR 101.3(g).
  
Your “Immune Active Adult Formula” product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the net quantity of contents in terms of weight, measure, or numerical count is not listed on the principal display panel of the label as required by 21 CFR 101.105.
 
Your “Immune Active Adult Formula” product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the serving size is incorrect. The terms serving or serving size for a dietary supplement are defined in 21 CFR 101.9(b) and 101.12, Table 2, as the maximum amount recommended on the label for consumption per eating occasion. For example, the label for “Immune Active Adult Formula” recommends 2 softgels daily, and therefore, the serving size should be 2 softgels.
 
Your “Immune Active Adult Formula” dietary supplement products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. 343(s)(2)(C)] because the label fail to identify the part of the plant (e.g., root, leaves) from which the dietary ingredient Melaleuca Alternaifolia is derived as required by 21 CFR 101.4(h)(1).
 
This letter is not an all-inclusive list of violations that exist in connection with your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for all of your products marketed by your firm to ensure that the claims you make do not cause them to violate the Act. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to promptly correct the violations may result in legal action without further notice, such as seizure or injunction. 
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations. Include any documentation that would assist us in evaluating your corrections. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
 
Your response should be directed to: Cicely Vaughn, Compliance Officer, U.S. Food and Drug Administration, Detroit District Office 300 River Place, Suite 5900, Detroit, MI 48207-4291. If you have any questions, you may contact Cicely Vaughn at (313) 393-8297 or via email at Cicely.Vaughn@fda.hhs.gov.
 
 
Sincerely yours,                                                           
/S/ 
Steven Barber
Acting District Director
Detroit District Office