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WARNING LETTER

Montana Emu Ranch Company Inc MARCS-CMS 509205 —

Product:
Animal & Veterinary
Recipient:
Recipient Name
Penelope S. Collins
Montana Emu Ranch Company Inc

Kalispell, MT 59904
United States

Issuing Office:
Seattle District Office

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
Seattle District
22215 26th Avenue SE, Suite 210
Bothell, WA 98021 

 

April 20, 2017
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
In reply refer to Warning Letter SEA 17-11
 
Penelope S. Collins, Owner
Montana Emu Ranch Company
P.O. Box 7041
Kalispell, MT 59904
 
WARNING LETTER
 
Dear Ms. Collins:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 305 Boorman Lane, Kalispell, Montana on September 19-22, 2016.  During our inspection, we collected product labeling and product literature associated with many of your products. In addition, the FDA has reviewed your website at the Internet address www.montanaemuranch.com in April 2017 and has determined that you take orders there for your products en'·zym, VitalStats, pro'·biotic, Ωmega Complex, EMUGENCY AID SPRAY, Deep Muscle Rub, Hot Spice & Ice, Herbal Wound Spray, Herbal Wound Salve, and Herbal Liniment. Based on our inspection and review of your firm’s product information, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
We acknowledge your response letters, dated September 28, 2016, and December 19, 2016, to the Form FDA 483, Inspectional Observations, issued to you at the conclusion of the inspection.  Your letters will be made part of your firm’s establishment file. The changes you have proposed or have made do not relate to the violations described below and will be evaluated during a subsequent inspection.
 
Unapproved New Drugs
 
The FDA reviewed your website at www.montanaemuranch.com, product labels, and brochures for the following Montana Emu Ranch brand products:  en'·zym, VitalStats, pro'·biotic, Ωmega Complex, EMUGENCY AID SPRAY, Deep Muscle Rub, and Hot Spice & Ice. The claims on your website and in your brochures establish that these products are drugs as defined in section 201(g)(1)(B) of 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. 
 
Examples of some of the claims that provide evidence that your products are intended for use as drugs are identified below. Some of these claims include evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease. In addition, some of the claims are contained in brochures that you include with some shipments of your products to customers.
 
en'·zym:
 
“Total Body Health” brochure:
  • “After suffering with Pancreatitis and being hospitalized…I cannot live without enzymes! After trying many name brands I have settled on Montana Emu Ranch Cultured Enzymes…the best I ever tried!”
VitalStats:
 
Product label:
  • Your VitalStats product label shows the image of an EKG tracing. The EKG tracing image implies to the consumer that the product is intended for use in the cure, mitigation, treatment, or prevention of heart disease.
Website: http://www.montanaemuranch.com/vital-stats-10-oz-powder-p/mtvs.htm    
  • “At my last exam [my doctor] told me he saw signs of the beginnings of macular degeneration. He did the first part of the [current] exam…Finally, he looked at me and said, ‘…Your eyes are BETTER than they were a year ago!’ Told him about the Vital Stats, which is the only major change…”
  • Photographs identified as March 2010 and June 2011 accompanied by:  “I have systemic eczema…The eczema covered my entire body…It now has healed…I apply…VitalStats…internally…”
“Total Body Health” brochure:
  • “Cholesterol reduction…protection from arteriosclerosis…”
  • “…anticancer effects particularly against skin and breast cancer.”
  • “At my last exam [my doctor] told me he saw signs of the beginnings of macular degeneration. He did the first part of the [current] exam…Finally, he looked at me and said, ‘…Your eyes are BETTER than they were a year ago!’ Told him about the Vital Stats, which is the only major change…”
pro'·biotic:
 
Product label:
  • “[M]any digestive disorders may be alleviated, proper colon and intestinal function may be restored…protect and defend the body against illness caused by pathogenic bacteria…” 
Website: http://www.montanaemuranch.com/pro-biotics-p/mtpb.htm
  • “I am happy to report…Your Probiotic has my GI tract regular after 4 yrs. of severe daily issues & relieved a lot of my pelvic/GI inflammation! Drs can’t believe it.”
  • “…I would like to order the following:…[P]robiotics…I got the results of my annual physical and my cholesterol is GOOD!!!! Thanks to all your products…”
  • Photographs identified as March 2010 and June 2011 accompanied by: “I have systemic eczema…After about six weeks I could really see that it was working…I apply…pro∙biotic internally…” 
“Total Body Health” brochure:
  • “[P]rotects against invading pathogens…anti-tumoral, anti-viral, and anti-retroviral…”
  • “[O]ver 20 years fighting an incurable autoimmune disease has left me with chronic diarrhea.  After taking the Montana Emu Ranch Probiotic, my stool has normalized…” 
Ωmega Complex:
 
Website: http://www.montanaemuranch.com/omega-complex-750mg-p/mtgc.htm
  • “[B]eneficial for psoriasis, acne, eczema, arthritis, and rosacea…control cholesterol…Essential Fatty Acid Deficiency Symptoms…Hair Loss…Failure of wound healing…inflammation Edema High triglycerides High blood pressure… Impairment of vision and learning ability…”
  • “I have Lupus and have suffered from skin lesions on my scalp…I started taking the Omega Complex and within a week…the skin lesions were gone. …The medications my doctor prescribed…didn’t work to heal…”
  • “After having cataract surgery…I got a couple of bottles of Ωmega Complex…it sped the healing up enormously…When I ran out…I got conjunctivitis…After restarting the Omega Complex…my eyes…felt amazing…”
  • “[U]sing your Omega Complex for a month…my Psoriasis is 60 percent clear/better…”
  • “[F]rom May to November my cholesterol dropped from 196 to 167.  The only change I made was taking the Omega Complex…”
  • “Ωmega Complex for eczema…stress and depression…After five days on the product the eczema stopped spreading, itching, and began to dry up.  I also noted a change in my frame of mind…depression…”
  • “[A]fter one month of taking…[Ωmega Complex]...my blood pressure went down from 143 to 123…”
  • “I have Rosacea.  I tried an anti-biotic from the Dr…The cream the Dr. gave me made my Rosacea worse…I started taking your ‘Ωmega Complex’…I am very Happy…”
  • “My blood pressure went from 186 to 146 in six weeks on the [Ωmega Complex]…”
  • “After 60 days on the [Ωmega Complex]…my cholesterol is down 30 points, my blood pressure is lower and my heart medications have been cut in half…”
  • “After suffering with severe psoriasis and enlarged liver for 40 years, both are normal after taking…[Ωmega Complex]…”
  • “[S]ystemic eczema…After about six weeks I could really see that it was working…[Omega Complex]…”
  • “I’ve suffered with undiagnosed nerve pain for approximately 5 years…these pills…with in one day, about 60 percent of my pain disappeared…”
  • “[M]y doctor told me that my knees were so bad that I would need knee replacements…I started taking it…That was 6 years ago and I am pain free…” 
“Certified Grade A Emu Oil Products” brochure:
  • “[C]an be used medicinally…beneficial for psoriasis, acne, eczema, arthritis, and rosacea…”
“Total Body Health” brochure:
  • “My cholesterol went from 214 to 166 in just three months…”
  • “[A]nti-inflammatory…promotes healing…”
  • “After…cataract surgery…Omega Complex…sped the healing…”
  • “[H]orrible psoriasis…In just 15 days of taking the Omega Complex…incredible relief…”
“100% Pure Montana Emu Oil” brochure:
  • “[D]iabetes, brain function, arthritis, PMS, high blood pressure, high cholesterol…”
  • “I have Rosacea.  I tried an anti-biotic from the Dr…The cream the Dr. gave me made my Rosacea worse…I started taking your ‘Ωmega Complex’…I am very Happy…”
  • “My back was so bad I almost had to go on disability…I started using the…Ωmega Complex…”
  • “After suffering with severe psoriasis and enlarged liver for 40 years, both are normal after taking…Emu Oil Gel Caps…”
  • “I take the Ωmega Complex capsules daily to prevent eczema and dermatitis out breaks…”
EMUGENCY AID SPRAY:
 
Website: http://www.montanaemuranch.com/emugency-all-purpose-spray-p/anes.htm
  • “[A]nti-inflammatory…soothe burns, bug bites, stings, rashes…skin infections…”
  • “[A]rea was always inflamed never healed…found Emugency…made such a difference…excellent to use for any rash…”
  • “3 month old baby…developed eczema…rashes on her arms, stomach, legs and bottom… recommended this product for the itching and healing…sprayed her all over and she IMMEDIATELY stopped scratching…less than 24 hours with using EMUgency…my baby’s skin is healing…”
  • Graphic photographs for day 4, day 8 and day 10 of hands accompanied by: “Second degree burns with raised blisters all over his hand…fingertips had blisters but those were gone the next day from the EMUgency…he felt no pain…Day 8, it doesn’t look like it was burnt this week…”
  • “[D]ouble mastectomy…My pain level for the first month was a ‘10’…your EMUgency First Aid Spray…gave me instant relief…My pain level, after using your product for two weeks, is now a ‘2,’…”
  • Graphic photographs for day one, day five and day ten accompanied by: “[O]ur 2 year old…poured BOILING…tea… EMUgency First Aid Spray…began using it immediately…able to discontinue the pain killer…kept free of any infection …within two weeks…is healing beautifully with nice new pink skin…”
  • “[T]reat and soothe burns, bug bites & stings, rashes…fungal infections, viral infections, inflammations, gram positive bacteria and other bacterial infections…”
  • “BENEFITS…anti-inflammatory, anti-microbial and healing…effective in treating skin cancer…recommended for babies, eczema and varicose veins…one of the most effective wound healers…cuts, stings, burns…eczema, sores and aches…anti-biotic, anti-bacterial, anti-microbial.  Very effective against gram positive bacteria such as streptococcus, staphylococcus, mycobacterium tuberculosis…effective against a variety of parasites…Anti-viral and anti-parasitic…cold sores, rashes, insect bites, sarcoma patches, herpetic sores, psoriasis, and eczema…heal wounds, eruptions and pustules…leg ulcers…Anti-spasmodic, analgesic…pain killer…ulcers on the skin…vermifuge…muscle ache and aching joint…headaches…wound healing without scarring…disinfectant…” 
“EMUGENCY 100% Natural All Purpose Products” brochure:
  • “Treat and soothe burns…Rashes and skin breakouts…Fungal and Viral infections…Inflammations…Gram positive bacterial infections…psoriasis…”
  • “[F]or all types of injuries including burns, cuts, scrapes, bumps, bug bites and stings, rashes, itchy, swollen, red or generally irritated skin…anti-inflammatory…effective transdermal carrier…speed the healing process…anti-bacterial, anti-fungal and anti-viral…control infections…”
  • Graphic photographs for day one, day five and day ten accompanied by: “[O]ur 2 year old…poured BOILING…tea…down off a high counter and tried to take a drink…find…with second degree burns on…his face, neck and shoulder…took him to the hospital…where he was treated and given Motrin for the pain…had…EMUgency First Aid Spray shipped to us…began using it immediately…able to discontinue the pain killer…kept free of any infection…within two weeks…is healing beautifully with nice new pink skin…”
Deep Muscle Rub:
 
Website: http://www.montanaemuranch.com/deep-muscle-rub-herbal-body-balm-p/anmr.htm
  • “[E]ase pain reduce inflammation…helpful with sprains, strains, bruises, aches and pains…bug bites, hemorrhoids, blemishes and some rashes…”
  • “I’ve suffered from a very painful and debilitating neuromuscular disease for 25 years…I could tell after the first application that it was different…numbness, tingling, burning…are greatly diminished…”
  • “Asthmatics can use this…have asthma…it helps open up our airways…”
  • “[E]ases the pain and soreness in muscles as well as the tendons and ligaments…”
  • “[U]sing…Deep Muscle Rub…for about a month…swelling is down-pain is down…”
  • “Deep Muscle Rub for my arthritic hands…the difference it’s making…”
  • “[F]ailed neck surgery and fibromyalgia…[Deep Muscle Rub] has been a life saver…”
  • “[Muscle Rub] is the greatest pain relief I have found…”
  • “Deep Muscle Rub Cream…has radically diminish [sic] my post operation pain …from a partial mastectomy…”
  • “BENEFITS…anti-inflammatory, anti-microbial …sprains and bruises…treat hemorrhages & hematomas…anti-bacterial, promotes healing of skin tissue…treating skin cancer…recommended for babies, eczema and varicose veins…pain relieving properties…migraine headaches, insomnia, acne…anti-viral…heals wounds by starving bacteria of oxygen…protects against the ultraviolet rays that cause sunburn…Inhibits formation of cancer causing compounds…Promotes healing of burned skin…rheumatic pains…wound healing without scarring…Anti-spasmodic, anti-septic, anti-convulsive…anti-rheumatic analgesic…used in respiratory diseases…athlete’s foot…” 
“All Natural Body Care” brochure:
  • “[B]eneficial to those suffering from bruises, sore muscles and joints…Reduce swelling…Anti-Inflammatory and Anti-Viral…”
  • “This [Muscle Rub] is the greatest pain relief I have found, including all the prescriptions, over-the-counter, etc…”
Hot Spice & Ice:
 
Product label:
  • “HERBAL PAIN RELIEVER”
Website: http://www.montanaemuranch.com/hot-spice-ice-herbal-pain-reliever-p/ansi.htm
  • “Arthritis…Hot Spice & Ice…my life has changed…IN LESS THAN THREE DAYS…NO pain, no discomfort…DOING EVERYTHING WITHOUT PAIN…”
  • “[U]nbearable sciatic and low back pain starting in my 4th month of pregnancy …Hot Spice & Ice…After a week…the shearing nerve pain in my back and down my leg is gone…”
  • “[A]ccident…screwed up my neck…severe whiplash…Hot Spice & Ice…seems to help loosen up my neck and back muscles…”
  • “The only product that actually works…severe Dystonia…pain is intolerable…Hot Spice & Ice…”
  • “BENEFITS…local anesthetic to relieve pain both on the surface and deep into the surface…anti-inflammatory, anti-microbial and healing properties…sprains & bruises…treat hemorrhages & hematomas…anti-septic…acne…muscle and joint pains…anti-arthritic, and anti-spasmodic…rheumatism…treat snake bites, dog bites, and stings of poisonous insects…Anti-infectious…reduce inflammation and kill germs…respiratory diseases…desensitizes nerve endings…”
“All Natural Body Care” brochure:
  • “[I]ncrease circulation and reduce pain…Relief for sore joints and muscle tension…Chronic pain sufferers of Arthritis, Bursitis and Tendonitis…”
  • “[U]nbearable sciatic and low back pain starting in my 4th month of pregnancy …Hot Spice & Ice…After a week…the shearing nerve pain in my back and down my leg is gone…”
The en'·zym, VitalStats, pro'·biotic, Ωmega Complex, EMUGENCY AID SPRAY, Deep Muscle Rub, and Hot Spice & Ice 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 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.
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your products en'·zym, VitalStats, pro'·biotic, Ωmega Complex, EMUGENCY AID SPRAY, Deep Muscle Rub, and Hot Spice & Ice are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.  Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, the labeling for en'·zym, VitalStats, pro'·biotic, Ωmega Complex, EMUGENCY AID SPRAY, Deep Muscle Rub, and Hot Spice & Ice fails to bear adequate directions for their intended uses and, therefore, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Unapproved New Animal Drugs
 
We also reviewed your website at www.montanaemuranch.com and brochures for the following Montana Emu Ranch brand products: Herbal Wound Spray, Herbal Wound Salve, and Herbal Liniment. The claims on your website and in your brochures establish that these products are intended for use in the cure, mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, these products are unapproved new animal drugs and introducing or delivering these products for introduction into interstate commerce violates the Act.
 
Examples of some of the claims that provide evidence that your products are intended for use as animal drugs are identified below. Some of these claims include evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease in animals.  In addition, some of the claims are contained in brochures that you may include with shipments of your products to customers.
 
Herbal Wound Spray:
 
Website: http://www.montanaemuranch.com/pet-and-livestock-wound-spray-p/plwsp.htm
  • “It is antibacterial … anti-inflammatory…”
  • “[M]are…deep gaping wound…could not be stitched…Wound Spray…by the end of the first month the wound was significantly smaller…”
  • Graphic photographs for July 24, 2008, and October 18, 2010, accompanied by: “[H]it … by a semi truck on July 24, 2008…the truck caught her right on the hip. She is fine. Just a light scar…Wound Spray wonder…Testimonial provided by Dr. Jim Chambers, DVM…”
  • Graphic photographs for June 1, 2007, June 11, 2007, and October 6, 2007, accompanied by: “[A]n Arabian caught in a barbed-wire fence, was brought to us bleeding profusely in shock the end of May 2007...WONDER OIL…Dr. Jim Chambers, DVM…”
  • “BENEFITS…anti-inflammatory…pain relieving properties…anti-bacterial …effective in treating skin cancer…recommended for …eczema  …anti-viral …anti-microbial…anti-biotic…anti-fungal …Anti-spasmodic…anti-convulsive …anti-rheumatic analgesic…parasitic…used for… rheumatism…abscesses…nail fungus…ringworm, dandruff, mites, scabies…muscle aches, sprains…”
“Montana Emu Ranch Pet & Livestock Products” brochure:
  • “For treatment of deep, fleshy wounds…Anti-bacterial…Powerful anti-inflammatory and anti-fungal...Antibiotic…Antiseptic…”
  • “[U]se[d] your…Herbal Wound Spray…on…my sled dog…had a 2 inch cut…I have NEVER seen a wound heal as fast…”
  • Graphic photographs for Day 1, Day 12, Week 3, Month 3 accompanied by: “WOUND SPRAY TESTIMONIAL…the WOUND SPRAY…is a miracle product…In JUST 12 days the big claw mark in the chest is healed…” 
Herbal Wound Salve:
 
Website: http://www.montanaemuranch.com/pet-and-livestock-herbal-wound-salve-p/plws.htm
  • “[H]ealing cuts, punctures, and abrasions…anti-inflammatory…reduce swelling and irritation…”
  • “[G]elding…with an ear fungus…incurable…after only a week or 2, those fungus spots were down to only a few…after…2 months, the fungus was almost completely gone…I haven’t seen the fungus come back for about 3 years…”
  • Graphic photographs of horse accompanied by: “The vet told me to put my horse down after he cut his hock, I used your salve and he’s been up and running for 5 years now…The second pic was taken 4 days after [the injury] and using your herbal wound treatment….[I]t amazed me how fast your product worked to help heal the muscle and skin tissues…”
  • “BENEFITS…Anti-inflammatory, anti-bacterial, promotes healing of skin tissue…effective in treating skin cancer…recommended for…eczema…pain relieving…soothing nerves…anti-viral…anti-microbial…Aides healing of … eczema, psoriasis, rashes, burns…anti-fungal…Reduces… rheumatic pains, anti-spasmodic…analgesic…used for… rheumatism…muscle pain…anti-convulsive…germicidal…”
“Montana Emu Ranch Pet & Livestock Products” brochure:
  • “[H]ealing cuts, punctures and abrasions…Powerful anti-inflammatory…reduce swelling and irritation…”
  • Graphic photographs for 12/12/01, 12/29/01, and 1/28/02 accompanied by: “WOUND SALVE TESTIMONIAL…Fifty-seven days after attack. Wound is down to the size of a quarter...”
Herbal Liniment:
 
Website: http://www.montanaemuranch.com/pet-and-livestock-herbal-liniment-p/plhl.htm
  • “Emu Oil's anti-inflammatory and healing characteristics transport and enhance the healing properties of herbs…Use after horseback riding to reduce swelling and inflammation…”
  • ”I have dogs and horses that I have used the Herbal Liniment on for a variety of injuries from muscle strains to abscesses and am very impressed on how quickly it works!...”
  • “We use your [Herbal] Liniment Emu oil on our Alaskan Malamute Sled dogs to treat sore joints and muscles. We’ve never had an injury until yesterday when Our Australian Sheppard came up lame and was not putting any weight on his rear left paw. When we examined him his paw was swollen and hot to the touch. Seeing no obvious injury I rubbed him down with your Emu Oil Liniment and within hours he was walking on it again...rubbed him down again before bed and today he is putting full weight on it…”
  • “BENEFITS…anti-inflammatory, anti-microbial and healing properties,…widely used to prevent or treat hemorrhages & hematomas…Excellent healing properties for damaged skin…Anti-bacterial, anti-fungal…anti-viral…Reduces inflammation…”
Because your Herbal Wound Spray, Herbal Wound Salve, and Herbal Liniment products are intended to cure, mitigate, treat, or prevent diseases in animals, they are drugs within the meaning of section 201(g)(1)(B) of the Act, [21 U.S.C. § 321 (g)(1)(B)]. Moreover, these products are new animal drugs, as defined by section 201(v) of the Act, [21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. They are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1].  Therefore, these products are unsafe within the meaning of section 512(a) of the Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of these adulterated drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].    
 
Misbranded Dietary Supplements
 
Furthermore, even if the labeling for your en'·zym, VitalStats, pro'·biotic, and Ωmega Complex products did not make claims that cause the products to be unapproved new drugs, these products would be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], in that the products do not comply with the food labeling requirements found in 21 CFR Part 101. 
 
1.    Your en'·zym, VitalStats, and pro'·biotic products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.
 
Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient on the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically:  Your en'·zym and pro'·biotic product labels bear the claim “contributes significantly high values of Omega 9.”  However, your products do not meet the requirements for use of the nutrient content claim “high…Omega 9” that are set forth in 21 CFR 101.54(b). In accordance with 21 CFR 101.54(b)(1), you may use the term “high” on the label of certain foods provided that the food contains 20 percent or more of the Reference Daily Intake or the Daily Reference Value (DRV) per reference amount customarily consumed. However, this regulation does not authorize your claims because there are no DRVs for Omega 9. Therefore, the use of the term “high” to characterize the level of Omega 9 in your en'·zym and pro'·biotic products misbrands your products under section 403(r)(1)(A) of the Act.
 
Likewise, your website indicates that the VitalStats product “presents potent antioxidants in the form of Tocotrienols.”  We note that there are no DRVs for tocotrienols.  Therefore, “potent…tocotrienols” to characterize the level of tocotrienols in your VitalStats product misbrands your product under 403(r)(1)(A) of the Act.
 
We note that there are alternative ways to convey the amount of Omega 9 in your products to consumers. For example, the amount of a nutrient in a food may be stated on the product label or labeling in accordance with the requirements in 21 CFR 101.13(i). If you want to seek authorization to use your current claim, you may submit a petition requesting FDA to authorize a new nutrient content claim (see 21 CFR 101.69). FDA’s review and authorization of a nutrient content claim prior to use in labeling ensures that the claim will provide consistent, meaningful information to consumers about the content of a product.
 
2.    Your VitalStats, pro'·biotic, and Ωmega Complex products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)], because the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36 as follows:
 
a.  The product label for VitalStats fails to bear nutrition information in the form of a “Supplement Facts” panel. This product is labeled with a “Nutritional Facts” panel but with components which reflect a dietary supplement, such as the use of “proprietary blend.” Additionally, the label includes nutrients such as Linoleic Acid and Steric Acid which are not provided for under 21 CFR 101.9.
 
b.  The product label for Ωmega Complex fails to list:
i.  The “Servings Per Container” under the subheading “Serving Size,” aligned on the left side of the nutrition label or in the net quantity of contents declaration, as required by 21 CFR 101.36(b)(1)(ii), and
ii.  The amount of Mixed Tocopherols, as required by 21 CFR 101.36(b).
 
c.  The product label for Ωmega Complex indicates Natural Vitamin E in the ingredients list. However, the source of the Vitamin E is not declared per 21 CFR 101.36(d), 101.3(g), and 101.4(a).
 
d.  The product labels for VitalStats and pro'·biotic contain intervening material within the Supplement Facts panel. The phrases “Proprietary Specialized Strain”, “Lactobacillus salivarius and plantarum,” “Whey Protein isolates from Milk,” and “Cultured on Soy” are considered intervening material. These phrases are intervening material per 21 CFR 101.2(e) and should be listed outside the Supplement Facts panel.
 
3.    Your en'·zym, VitalStats, and pro'·biotic 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 labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the products is derived, as required by 21 CFR 101.4(h)(1).  Specifically, you fail to list from which part of the plant your yucca or yucca powder ingredient is derived.
 
4.    Your VitalStats product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(a) and (g). In particular, we note several bacteria are listed with an abbreviation for the genus. The genus name along with the species must be spelled out initially. If the same genus is being listed with a different species, then the genus may be abbreviated with the first letter of the genus being capitalized and followed by a period and the species spelled out.  
 
5.    Your en'·zym and Ωmega Complex products are misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on each label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Specifically,
 
a.  The directions for the Ωmega Complex Emu Oil suggest the consumer take three to six soft capsules daily. The serving size per the directions would be six soft capsules; however, the Supplement Facts label indicates three soft capsules as the serving size.
 
b.  The suggested use for the en'·zym product is declared as 1 to 4 capsules. The serving size should therefore be 4 capsules; however, the Supplement Facts label indicates 1 capsule as the serving size.
 
This letter is not intended to be an all-inclusive list of the 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 your firm complies with the Act 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 regulatory action without further notice, including, without limitation, seizure and injunction.
 
We also offer the following comments:
  • Your VitalStats product labeling on your website contains the statement “No Dairy” but the product label lists “Micro-Filtered Protein from Whey” as an ingredient in the Toco Blend. Whey protein is a dairy ingredient; therefore, one of these statements is false or misleading. False or misleading statements in labeling may cause a product to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)].
  • You have identified Mixed Tocopherols in your Ωmega Complex product as a “natural source of Vitamin E to protect freshness.” Vitamin E should be listed when it is intended to supplement the diet as a dietary ingredient and when present at an amount greater than what would be listed as zero. If the sole purpose of the ingredient is for freshness and it is present at levels that could be declared as zero, it should not be listed in the Supplement Facts panel [21 CFR 101.36(b)(2)].
  • The label for your en'·zym product lists the “serving size” immediately to the right of the “Supplement Facts” header. This statement should be located immediately below this header and aligned on the left side of the nutrition label [21 CFR 101.36(b)(1)(i)].
  • The serving size on your VitalStats product identified as “Tbls.” If this is intended to reflect a tablespoon, the correct abbreviation is “tbsp” [21 CFR 101.9(b)(7)(iv)].
  • Your VitalStats product fails to present the calories per serving to the nearest 5 grams [21 CFR 101.9(c)(1)].
  • Your VitalStats product label lists “Trans Fats,” 0 g, before the “saturated fats.” In accordance with 21 CFR 101.36(b)(2), any (b)(2)-dietary ingredient, such as trans fat that is not present, or that is present in an amount that can be declared as zero according to 21 CFR 101.9(c) shall not be declared. Additionally, the unit of measure for the “Saturated Fats” on your product label is listed as “mg;” the unit of measure should be “gram” and the quantitative amount should be listed to the nearest 0.5 gram. Furthermore, the term “fat” should be used and not “fats.”
  • Your en'·zym and pro'·biotic product labels bear the statement “Percent Daily Values are based on a 2,000 calorie diet.”  This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).  None of those dietary ingredients is present on the label, so the statement is not permitted.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, and to prevent these violations from occurring again. You should include documentation of corrective actions you have taken to date. If your firm’s planned corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections.
 
Your reply should be sent to: U. S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Maria P. Kelly-Doggett, Compliance Officer. Refer to the identification number WL SEA 17-11 when replying.  If you have any questions regarding any issues in this letter, please contact Compliance Officer Maria Kelly-Doggett by telephone at 425-302-0427. 
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director
 
cc: 
Donald D. Collins, Co-owner
Montana Emu Ranch Company
P.O. Box 7041
Kalispell, MT 59904
 
Montana Department of Public Health and Human Services
Food and Consumer Safety Section
Cogswell Building, 1400 Broadway Street
P.O. Box 202951
Helena, Montana 59620-2951
 

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