Inspections, Compliance, Enforcement, and Criminal Investigations

PA Constans - Minnesota Emu 2/23/18

 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Foods - West Division 1
250 Marquette Avenue, Suite 600
Minneapolis, MN SS401
(812) 334-4100 

 
 

 

February 23, 2018
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                                        Refer to CMS 543014
 
 
Patricia A. Constans
Owner
PA Constans – Minnesota Emu
24200 Fairwood Lane
Nevis, Minnesota 56467-4218
 
Dear Ms. Constans:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your own-label distributor facility located at 24200 Fairwood Lane, Nevis, Minnesota, on September 11 and 13, 2017. As part of the inspection, FDA collected product labeling and reviewed your website at the Internet address https://www.emumagic.com. We have determined that you take orders there for your Emu oil products including OmegaMagic® softgel capsule labeled as a dietary supplement, Premier™ Emu Oil, and Deep Pain Relief™ Concentrated Analgesic Liquid. The claims on your website establish that the products are 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), 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. You can find the Act and the FDA regulations through links on FDA’s home page at www.fda.gov.
 
Examples of some of the claims on your Premier™ Emu Oil and Deep Pain Relief™ Concentrated Analgesic Liquid products that provide evidence that your products are intended for use as drugs include:
 
Premier™ Emu Oil product 
  • Anti-inflammatory (product label)
  • “[A]nti-inflammatory…”
  • (testimonial) “I have [dry itchy skin]* on my midsection and legs. Emu Oil really does help alleviate the redness and itching. I would rather use a natural product than a pharmaceutical.” *redacted as per FDA regulation.” 
Deep Pain Relief™ Concentrated Analgesic Liquid product
  • “Analgesic” (product label)
  • The product name, “Deep Pain Relief” (product label)
  • “[A]nti-inflammatory” (product label)
  • “[S]oothe your aches and pains” (product label and website)
  • (testimonial) “After spinal surgery several years ago, my aunt’s back gives her so much pain that she will lay in bed for days at a time unable to get up. After using EMU Deep Pain Relief, she states the pain is alleviated tremendously.” 
Examples of some of the ingredient claims on your website https://www.emumagic.com that provide evidence that your products are intended for use as drugs include:
 
Ingredient:  emu oil
  • “Australia’s Aborigines have been using emu oil for centuries to treat pain, burns and bug bites & stings.”
  • “our customers have reported using our emu oil to help them with:
  • Reducing pain and inflammation
  • Soothing diaper rash…
  • Soothing sunburn
  • Soothing skin from bug bites and scrapes
  • Minimizing skin scarring***”
OmegaMagic® Product
  • [E]mu oil is an amazing anti-inflammatory…”
  • (testimonial) “I have only used one bottle of the Omega Magic, but already my arthritis and stiffness in my knee and hands is 100% better than it was. Hoping it will get even better! The pain is almost gone. Works Great!”
  • (testimonial) “I had toenail fungus for decades. Used medically prescribed Rx and many over the counter products. Nothing worked. Starting using Omega Magic and after 9 weeks – the old nail sluffed off and a healthy new nail was exposed.” 
Your website https://www.emumagic.com also contains a link to the website http://www.emumagic.co/ which contains evidence of intended use in the form of personal testimonials recommending or describing the use of Emu Oil products for the cure, mitigation, or treatment of disease. Examples of such testimonials include:
 
OmegaMagic® Product
  • “Zoster Pain***After a car accident…I came home from the hospital…with (a painful and itching skin disorder***)…(I started) the Deep Pain Relief and Premier pure emu oil and 2 wks later the OmegaMagic. I could tell it was making me feel better!!! The sores (some were infected) cleared up.”
Premier™ Emu Oil Product
  • “I rubbed it on my burns and it was instantly pain free…Within 6 days I was completely healed and you never knew I had been burned.”
  • I started my radiation treatment in October…My burns were very minimal and I had no pigment changes at all. My oncologist agreed that this was due to me being faithful with moisturizing with Emu Oil.”
  • “My daughter has battled with severe (itchy flakey skin disorder**) and large volumes of allergies her entire life…Because her skin is often open from itching, she is hospitalized often 2 times a year or more for major skin breakdowns and (very bad**) infections…The EmuMagic oil…WORKED!” 
Deep Pain Relief™ Concentrated Analgesic Liquid Product
  • “I am very happy to have found your EmuMagic Deep Pain Relief. I used it on…a bee or wasp bite very swollen…one day later the redness is gone and no itching…”
  • “Love the Pain Relief. I have had a headache for 3 days taking lots of medication, which was not helping. Within a few minutes my headache was gone!” 
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 sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 335(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law. Many of these products may be legally marketed as dietary supplements if claims about diagnosis, cure, mitigation, treatment, or prevention of disease are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations. 
 
Under the Act, as amended by the Dietary Supplement Health and Education Act, dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (structure/function claims), if certain requirements are met. However, claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims), except health claims authorized for use by FDA, cause the products to be drugs. The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at http://www.gpo.gov/fdsys/pkg/FR-2000-01-06/html/00-53.htm, codified at Title 21, Code of Federal Regulations, section 101.93(g), 21 CFR 101.93(g). 
 
In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs. 
 
Certain over-the-counter drugs are not new drugs and may be legally marketed without prior approval from FDA. Additional information is available in 21 CFR Parts 310 and 330-358, which contain FDA’s regulations on over-the-counter drugs. 
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products.  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 you comply 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.
 
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in section 415 of the Act, 21 U.S.C. § 350d, and our implementing regulation at 21 CFR Part 1, Subpart H. During your inspection you were advised of this requirement. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act, 21 U.S.C. § 331(dd). Our records indicate that, to date, this facility has not been registered with FDA.
 
As the 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 comply with the law.
 
We request that you or an individual authorized by you register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at https://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
 
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA’s food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or (301) 575-0156, or by writing to the agency at the following address:
 
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
 
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility’s registration number using the same method used to submit the registration to FDA.
 
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the 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 actions within 15 working days, state the reason for the delay and the time within which you will complete the correction.
 
Your reply should be sent to Demetria L. Lueneburg, Compliance Officer, U.S. Food and Drug Administration, at the address on the letterhead. If you have any questions about this letter, please contact Ms. Lueneburg by telephone at (612) 758-7210. 
                                                                                                                                               
Sincerely,
/S/ 
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations
 

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