Emu Oil Seller Warned For Claims

FDA shoots off warning letter to Penelope Collins and Montana Emu Ranch Company
Montana Emu Ranch Company Warning Letter
FDA Warning Letter to Penelope Collins and Montana Emu Ranch Company

Remember emu oil? Well, it’s back and it’s bringing its over-hyped promises along for the ride.

This morning the U.S. Food and Drug Administration, or FDA, made public its official warning letter to emu oil hawker Penelope Collins and her business, Montana Emu Ranch Company. The letter is lengthy and covers a number of products that are marketed in such a way as to constitute what the agency refers to as “serious violations” of the Federal Food, Drug, and Cosmetic Act.

VitalStats

The company’s VitalStats powder product was listed in the letter for alleged claims made on its packaging, the product’s web page, in customer “testimonials” and in a marketing brochure. Those claims covered medical conditions like:

  • Heart disease
  • Macular degeneration
  • Eczema
  • Arteriosclerosis
  • Cancer

Pro’biotic

The company’s pro’biotic supplement was also called out for claims and testimonials made through various marketing channels. Some of its promised health benefits were for conditions including:

  • Digestive disorders
  • Pelvic inflammation
  • Eczema
  • Tumors

Certified Grade A & 100% Pure Montana Emu Oil Products

And, of course, Collins’ emu oil products also caught the eye of investigators. Some of the claims reportedly attached to the Certified Grade A Emu Oil covered conditions like:

  • Arthritis
  • High cholesterol
  • Inflammation
  • Post-operative cataract healing
  • Skin conditions including psoriasis, acne, eczema and rosacea

The 100% Pure Montana Emu Oil was touted for:

  • Diabetes
  • Arthritis
  • Brain health
  • Back pain
  • Premenstrual syndrome
  • Various skin conditions
  • Inflammation
  • “Enlarged” liver

Other Montana Emu Ranch Company products were also singled out. Those include the company’s:

  • en’·zym
  • Ωmega Complex
  • EMUGENCY AID SPRAY
  • Deep Muscle Rub
  • Hot Spice & Ice

The troublesome claims, says the agency, make the products “unapproved new drugs” because they are marketed for treatment or prevention of disease. But even if they weren’t, the products would still be “misbranded” because they’re promoted for conditions that an average person cannot accurately diagnose or effectively treat at home.

The FDA’s warning letter to Penelope Collins and Montana Emu Ranch Company is long but not, according to the agency, intended to be an exhaustive list of all possible violations. The company was given the standard 15 working days to address the FDA’s allegations of bogus claims and it appears to have done so–at least as far as I can tell. The company’s website, for example, has been reworked and the offending wording removed.

A Bit Of Information On Emu Oil

Emu oil is an interesting remedy in alternative medicine. It is exactly what it sounds like–fat taken from emus and melted, filtered and either packaged for sale or sent for use in soaps, cosmetic, muscle rubs and a variety of other products.

The science behind emu is also interesting. Despite its popularity emu oil has not seen exhaustive testing for many of the conditions for which it is marketed. I can find, for example, only 1 study looking at emu oil for cancer.

Currently, emu oil’s greatest potential may lie in its ability to soothe skin, although a 2016 study found that emu oil actually delayed burn healing. Emu oil also appears to work as a safe and effective carrier for topically applied arthritis remedies.

2 Comments

  1. I read the FDA’s letter and nearly all of their comments stemmed from customer testimonials where the customer mentioned condition names such as eczema, burns, etc. There are tens of thousands of other sellers of over-the-counter products that include customer testimonials on their websites, it’s standard practice, but they haven’t (yet) been called out by the FDA. Montana Emu Ranch didn’t make the claims, their customers did because they were so happy with the results.

    I use emu oil myself and checked into it extensively before starting. There is quite a lot of medical research that’s been done on the effects of emu oil. Here are 52 to start with:
    Whitehouse MW, Turner AG, Davis CKC, Roberts MS. Emu oil(s): A source of non-toxic anti-inflammatory agents in aboriginal medicine. Inflammopharmacology . 1998;6:1-7.
    Politis MJ, Dmytrowich A. Promotion of second intention wound healing by emu oil lotion: comparative results with furasin, polysporin, and cortisone. Plast Reconstr Surg . 1998;102:2404-2407.
    Lopez A, Sims DE, Ablett RF, et al. Effect of emu oil on auricular inflammation induced with croton oil in mice. Am J Vet Res . 1999;60:1558-1561.
    Yoganathan S, Nicolosi R, Wilson T, et al. Antagonism of croton oil inflammation by topical emu oil in CD-1 mice. Lipids . 2003;38:603-607.
    Penturf M, O’Bannon S, Griswold J. Evaluation of emu oil in lubrication and treatment of healed burned wounds. Presented at: Annual Meeting of the American Burn Association ; March 18-21, 1998; Chicago, IL.
    “Looking Into Emu Oil” . By Frank Orthoefer. ACH Food Companies
    “Fatty Acid Composition: Comparative Analysis of Emu, Ostrich, and Rhea Oil” . By M C. Craig-Schmidt and K R Willian, Department of Nutrition and Food Science. Auburn University
    “Structure of Emu Oil – Emu Oil Fatty Acid Analysis”. By Margaret C. Craig-Schmidt, Ph.D., Amanda Brown M.S., Paul C. Smith, D.V.M., Ph.D. Auburn University
    “Emu Oil Processing and Properties”. By E. Hernandez, Ph.D. Food Protein Research & Development Center. Texas A&M University
    Bennett, G. Gatherings of a Naturalist in Australasia, John Van Voorst, London, 1860
    Code, W (1997) Emu Cream Assists Lidocaine: Local Anesthetic Absorption through Human Skin. 88th American Oil Chemists Society annual meeting, May 1997. Reprinted from AEA News, Summer 1997 issue
    Craig-Schmidt M and K.R. Willian, K.R. (1997) Fatty Acid Composition: Comparative analysis of emu, ostrich and rhea oil.
    Abstracts: 88th AOCS Annual Meeting & Expo, Seattle WA, May 1997
    Davies, Max (pers comm). Emu Oil – The Benefits and the Claims. Davies, Stephen (1996) Australian Emu 11:6-8
    Ghosh, P and Whitehouse, M.W (1993) Experimental Study to Determine the Anti-Arthritic Activity of a New Emu Oil
    Hernandez, E (1995) Emu Oil Processing and Properties. AEA News, November 1995
    Hopkins, L (1997). Composition of Emu Oil: The Micro View. Reprinted from AEA News, Spring 1997 issue
    Johns, J. G, (1996). Oil markets and Marketing. Proceedings World Emu Symposium. Adelaide. Ed. Keogh, K. Hartley. Management Group. SOUTH AUSTRALIA.
    Johns, J. G, (1996) Oil Production Techniques and Standards. Proceedings World Emu Symposium. Adelaide. Ed. Keogh, K. Hartley Management Group. SOUTH AUSTRALIA.
    Leichhardt, L. Journal of an overland Expedition in Australia, from Moreton Bay to Port Essington, a distance of upwards of 3000 miles, during the years 1844-1845. T. & W. Boone, London, 1847. Low, T. Bush Tucker. Angus & Robertson, Sydney, 1989.
    Minnaar, Maria (1998). The Emu Farmers Handbook. Nyoni Publishing, TEXAS USA.
    Smith, P.C and Craig-Schmidt, M. (1995). Fatty acid analysis of Emu oil. Australian Emu 4:33-34. (Also in AEA News, September 1994).
    St George Marketing Solutions. (1997). Marketing Plan for Emu Oil, grade 1 for the Australian Emu Industry. Kinko,s International Australia, SYDNEY. Thompson, P (1997) Oils Aint Oils. Australian 17:8-9
    Whitehouse, Michael (1997) Results of Oil Research. Australian Emu 17:8-9.
    Whitehouse, M.W and Turner A (1997) Inflammopharmacology, San Francisco, March 1997 conference proceedings. Reprinted from AEA News, Summer 1997 issue)
    Zemstov, Alexander, Gaddis, Monica, and Montalvo-Lugo, Victor. (1995). Moisturising and cosmetic properties of Emu oil: a double blind study. Australian Emu 6:31-33. (Also in AEA News, October/November 1994).17
    Fukushima M, Ohashi T, Sekikawa M, Nakano M. Comparative hypocholesterolemic effects of five animal oils in cholesterol-fed rats. Biosci Biotechnol Biochem 1999;63:202-5.
    Lopez A, Sims DE, Ablett RF, et al. Effect of emu oil on auricular inflammation with croton oil in mice (abstract). Am J Vet Res 1999;60:1558-61.
    Politis MJ, Dmytrowich A. Promotion of second intention wound healing by emu oil lotion: comparative results with furasin, polysporin, and cortisone. Plast Reconstr Surg 1998;102:2404-7.
    Zemtsov A, Gaddis M, Montalvo-Lugo VM, Zemstov A. Moisturizing and cosmetic properties of emu oil: a pilot double blind study. Australas J Dermatol 1996;37:159-61.
    Snowden JM, Whitehouse MW. Anti-inflammatory activity of emu oils in rats. Inflammopharmacology . 1997;5:127-132.
    Explore: Emu Oil Research: Emu Oil: The Undiscovered Secret
    Emu Oil Institute: Properties of Emu Oil.
    “Emu Oil (S): A Source of Non-Toxic Transdermal Anti-Inflammatory Agents in Aboriginal Medicine”; Inflammopharmacology. 1998; 6: 1-8.1997 Kluwer Academic Publishers. Printed I the Netherlands. Drs: M.W. Whitehouse, A.G. Turner, C.K.C. Davis and M. S. Roberts.39.
    “ Gatherings of a naturalist in Australasia”. London: John Van Voorst, Paternoster Row: 1860.
    “Emu Oil – Its Anti-Inflammatory Properties” – Rural Industries Research & Development Corporation Report. RIRDC Publication No. 99/133; RIRDC Project No DAW-82A; Dr John M. Snowden.
    “Evalauation of Emu Oils for Anti-inflammatory Activities” by Dr Margaret Craig-Schmidt, Dr Michael Wellesley Whitehouse PhD in Chemistry University Oxford and MP Ghosh.
    Experimental Study to Determine the Anti-Arthritic Activity of New Emu Oil Formulation (EMMP). (1993). By: Dr. Peter Ghosh at Royal North Shore Hospital of Sydney, Australia and Dr. Michael Whitehouse at University of Adelaide, Australia. Summary: A combination of emu oil with a suitable transdermal transporter is found to show anti-inflammatory (anti-rheumatic) activity in various rat models. DetailsTiming: Experiments and observations occurred on subgroups of patients over a three-month period. Research Experiment Purpose: Dr. Whitehouse and Dr. Ghosh were trying to observe: If Emu Oil is an anti-inflammatory agent for the painful swelling that takes place in joints and bones of those suffering from Arthritis; and, Does Emu Oil eliminate the arthritis pain for arthritis sufferers in their bone cartilage and swollen joints. Results/Conclusions: In 14 days, Emu Oil had eliminated all inflammation caused by arthritis joint swelling and bone abrasion due to lack of cartilage. None of the patients experienced arthritis pain in their joints and bones after 14 days of topical application. The pain caused by constant friction of bones rubbing together had disappeared. Arthritis Pain Reduction: Days of Emu Oil Treatment Rate of Reduction in Pain:1 day – 1%; 4 days – 30%; 7 days – 50%; 11 days – 82% and 14 days – 100%. Reduction of Arthritic Swelling: Days of Emu Oil Treatment Swelling Reduction in Arthritic Joints: 1 day – 2%; 6 days – 22%; 12 days – 48% and 17 days – 100% *Information obtained from the American Emu Association, 1995.
    Fatty Acid Analysis of Emu Oil. By: Dr. Paul Smith, Dr. Margaret Craig-Schmidt, Amanda Brown at Auburn University. Summary: Analysis of fatty acids in emu oil reveals that it contains approximately 70% unsaturated fatty acids. The major fatty acid found in emu oil is oleic acid, which is mono- unsaturated and which comprises over 40% of the total fatty acid contents. Emu oil also contains both of the two essential fatty acids (EFA’s) which are important to human health: 20% linoleic, and 1-2% alpha-linolenic acid.
    Fatty Acid Composition: Comparative analysis of emu, ostrich and rhea oil. By: Dr. Margaret Craig-Schmidt and K.R. William at Auburn University. (1996) Summary: A comparison between oil rendered from the fat of the emu, the ostrich and the rhea reveals that the predominant fatty acid in ostrich and rhea oils in palmitic acid, and of emu oil is oleic acid.
    International Emu Oil Guidelines. By: The AEA Oil Standards Team, Lee D. Smith (Team Leader) (1997). Summary: (a) The text part of the Guidelines consists of the Executive Summary, the Introduction, and Background, and gives the requirements for the handling of emu fat to ensure optimum quality of the finished oil, from bird handling and processing to fat handling and cold storage. Actual oil testing criteria are summarized within the Emu Oil Guidelines. The testing criteria would be required by laboratories testing samples of emu oil to make sure the oil satisfies the guidelines for safety and consistency. All oil testing laboratories and oil rendering facilities should have a copy of the Emu Oil Guidelines.
    Emu Oil: Comedogenicity Testing. By: Department of Dermatology, at University of Texas Medical School, Houston. Summary: Testing using the rabbit ear histological assay, with emu oil in concentrations of 25%, 75% and 100% shows that emu oil in concentrations of up to 100% is non-comedogenic, i.e. it does not clog the pores of the skin.
    Moisturizing and Cosmetic Properties of Emu Oil: A Double Blind Study. By: Dr. Alexander Zemtsov, Indiana University School of Medicine: Dr. Monica Gaddis, Ball Memorial Hospital; and Dr. Victor Montalvo-Lugo, Ball Memorial Hospital. Summary: Eleven human subjects took part in a double-blind clinical study which compared emu oil with mineral oil in texture, skin permeability and moisturizing properties, as well as comedogenicity and irritability to the skin. No irritation to the skin was observed with either oil. However, comedogenicity of emu oil was significantly lower than that of mineral oil, and all subjects stated a unanimous preference for emu oil.
    Composition of Emu Oil: The Micro View. By: Dr. Leigh Hopkins, AEA Oil Standards Team (Research Leader) . Summary: When compared with human skin oil, the fatty acid composition of emu oil is found to be quite similar. In both types of oil, mono-unsaturated oleic acid is the most prevalent fatty acid, followed by palmitic acid, then linoleic acid, which is an EFA. This similarity may be one of the factors enabling emu oil to have such a positive action on human skin.
    Emu Cream Assists Lidocaine: Local Anesthetic Absorption through Human Skin. By: Dr. William Code. (Presented at the 88th American Oil Chemists Society annual meeting. Summary: In his initial work with an emu oil based cream combined with spearmint oil and lidocaine, Dr. Code has found that this mixture appears to produce a reduced sensation in the skin as compared with another mixture of local anesthetics without emu oil. The goal is to reduce sensitivity to the skin in a safe, fast and effective way for procedures such as suturing or giving injections.
    Emu Oil: A Source of Non-Toxic Transdermal Anti-Inflammatory Agents in Aboriginal Medicine (1997). By: Dr. Michael Whitehouse and Athol Turner, Dept. Of Medicine, University of Queensland, Australia (Source: Inflammapharmacology, San Francisco, March 1997 conference proceedings). Summary: Ongoing studies on the anti-inflammatory activity of emu oil, as tested using the arthritis-induced rat model, indicate that different emu oils vary in their ability to suppress arthritic symptoms and that a chemical test for biological activity is needed rather than continuing to use the rat model.
    Anti Aging Treatment Non-Surgical Facial Rejuvenation & Natural Results. Melb & Shepparton. In an article in “Explore” magazine, Serena DuBois cites emu oil’s ability to penetrate below the outermost layer of the epidermis, also known as the stratum corneum, as perhaps its single most important property. DuBois, who has written extensively on health and nutrition, credits this property to emu oil’s high levels of oleic acid, a monounsaturated fatty acid. Many other medical creams and lotions designed for topical application are unable to break through this barrier to reach the tissues beneath it. DuBois points out that massage therapists and chiropractors often use emu oil for this reason “because it gets into the muscles and relaxes them so that the chiropractic work that has been done lasts longer.” She suggests that this property of emu oil is likely to provide a new pathway for delivery of medicinals to deeper tissue that is far less expensive than liposomes or iontophoresis.
    Fatty Acid Analysis of Emu Oil. By: Dr. Paul Smith, Dr. Margaret Craig-Schmidt, Amanda Brown at Auburn University. Summary: Analysis of fatty acids in emu oil reveals that it contains approximately 70% unsaturated fatty acids. The major fatty acid found in emu oil is oleic acid, which is mono- unsaturated and which comprises over 40% of the total fatty acid contents. Emu oil also contains both of the two essential fatty acids (EFA’s) which are important to human health: 20% linoleic, and 1-2% alpha-linolenic acid.
    Hobday GR. Emu oil. Australian Emu . July/August 1994.
    Rokicki R. The great emu comeback. Mother Earth News . October/November 2000:16-17.
    American Emu Association. AEA Oil Standards Team. International Emu Oil Standards . Revision 2. May 1998.
    Minnaar M. Introduction to emu oil: fats and oils in human health. In: Minnaar P, Minnaar M, Minnaar P. The Emu Farmers Handbook . Vol 1. Groveton, TX: Myoni Publishing Co.; 1997.

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  2. Actually, the FDA has long considered the use of customer testimonials to be marketing, just as if the company itself made the claims.

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