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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Emu Products and Management, Inc. (EPMI) 11/19/12

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

 

 

November 19, 2012 
 
2013-DAL-WL-012
 
WARNING LETTER
 
 
UPS OVERNIGHT
 
Tony L. Anderson, President
Emu Products & Management, Inc.
1202 Ben Rd.
Marlow, OK 73055
 
Dear Mr. Anderson:
 
This is to advise you that the U. S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.EPMI.net in July 2012. Based on our review, your Multi-Omega Gel Caps, Recovery Gel Caps, ARP Gel Caps, Extreme Cryo Gel, F.A.C.E. Doctor, Skin Doctor, and Pure Emu Oil products appear to beare  promoted for uses that cause these products to be drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §321(g)(1)(B) and § 321(g)(1)(C)]. The claims on your website indicate establish that these products are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act. The marketing of these products with these claims evidencing these intended uses violates the Act. You may find the Act and the FDA’s regulations through links on FDA’s home page at www.fda.gov.
 
Examples of some of the claims include:
 
  • Multi-Omega Gel Caps:
    • “Multi-Omega will … lower cholesterol… and counteracts the dreaded Syndrome X (high blood pressure, diabetes, fatigue, cardiovascular disease, weight gain and obesity).”
  • Recovery Gel Caps:
    • “This gel cap will help reduce LDL (bad cholesterol) and triglycerides…” 
  • ARP Gel Caps:
    • “ARP Emu Oil Gel Caps will help alleviate aches and pains due to the anti-inflammatory properties. ARP will not only relieve arthritis pain but will also reduce joint inflammation, relieve swelling and reduce muscle soreness.”
  • Extreme Cryo Gel:
    • “Fast acting Extreme Cryo Gel is a unique blend of Essential Oils and natural herbs to alleviate pain associated with arthritis…”
  • In a video on your website for your Extreme Cryo Gel:
    •  “Does arthritis keep you from doing simple chores? Do your muscles and joints constantly hurt? You need extreme relief today. Extreme Cryo Gel with MSM, glucosamine, and emu oil will help ease the pain, guaranteed.”
  • F.A.C.E. Doctor:
    • “Face Doctor is an alternative treatment to acne…Face Doctor was developed for people with unresolved acne problems….”.
  • Skin Doctor:
    • “Skin Doctor is a Unique formula for major skin conditions such as psoriasis, eczema or itchy skin disorders …”
  • Pure Emu Oil product:
    • “Emu Oil is a natural substance that offers the benefits of pain relief without the harsh side effects of prescription drugs. It is said to . . . reduce the pain and swelling of arthritis. . . ”.
 
Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, these products are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)], a new drug may not be legally marketed in the U.S. without prior approval from FDA in the form of a New Drug Application (NDA).  A description of the new drug approval process can be found on FDA's internet website at

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
HowDrugsareDevelopedandApproved/ApprovalApplications/
NewDrugApplicationNDA/default.htm.
 
Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
 
Furthermore, your Multi-Omega Gel Caps, Recovery Gel Caps, and Skin Doctor products 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, your Multi-Omega Gel Caps, Recovery Gel Caps, and Skin Doctor products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these products 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)].
 
(b)(3)(a) 
 
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
 
(b)(3)(a)
  
This letter is not an all-inclusive statement of violations associated with your products or their labeling.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
 
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, including identifying violations and making corrections to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days state the reason for the delay and the time frame in which the corrections will be implemented.    
 
Please direct your written response to Seri L. Essary, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Ms. Essary at (214)253-5335. 
                                                                       
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director