Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm556843.htm
Timestamp: 2019-04-21 22:06:55+00:00

Document:
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.
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.
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.
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)].
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.
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)].
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.
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.
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.
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.
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.
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 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.

References: § 321
 § 321
 § 352
 § 201
 § 353
 § 352
 § 331
 § 321
 § 321
 § 321
 § 360
 § 351
 § 331
 § 343
 § 343
 § 343
 § 343
 § 343