Tobin's Royal Stag, Inc. dba Tobin Farms Velvet Antler 4/19/17

Transcription

1 Tobin's Royal Stag, Inc. dba Tobin Farms Velvet Antler 4/19/17 UNITED PARCEL SERVICE OVERNIGHT DELIVERY April 19, 2017 Darrell Tobin Owner Tobin's Royal Stag, Inc. P.O. Box 108 Alna, ME Dear Mr. Tobin: WARNING LETTER CMS # New England District Office (NWE DO) One Montvale Avenue, 4th floor Stoneham, MA Phone The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 1409 Alna Road, Alna, ME, from August 31 through September 13, Based on our inspection, laboratory analysis of samples of in process products and materials, and review of your website and product labeling collected during the inspection, we identified serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and its implementing regulations. You can find the Act and FDA s regulations through links on FDA s home page at ( The violations are described below. Unapproved New Drugs and Misbranded Drugs 1/6

2 FDA reviewed your product brochure and website at the Internet address tobinfarms.com in January 2017 and determined that you take orders on your website for the products Velvet Antler Capsules and Velvet Antler Powder. The claims in your product brochure and on your website establish that the products are drugs under 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 product is intended for use as a drug include: From the brochure you provide to customers along with the sale of finished products: On your document titled Good Health to You From Dean And The Gang : Glucosamine [a constituent of your Velvet Antler capsules]:... reported to relieve joint pain On your document titled Velvet Antler : Support Recovery from Degenerative Conditions produces anti tumor and anti viral effects Anti cancer stimulation of joint repair Accelerates wound healing For over 2,000 years, the Chinese, Koreans, and other Asians have regarded deer as the ultimate medicinal animal. The most prized part is velvet antler because it s essential to well being. They use it as preventive medicine for 52 diseases! Chinese Uses/Additional Benefits of Velvet Antler... Anemia... High blood pressure... Prevent arthritis... Remedy arthritis... Osteoarthritis and osteoporosis... Rheumatoid arthritis CFS [chronic fatigue syndrome]... TMJ [temporomandibular joint disorder]... DJD Degenerative JointDisease... Lupus... FIBROMYALGIA... MS [multiple sclerosis]... High cholesterol... Remedy kidney and liver problems... Stomach ulcers... Eczema... Schizophrenia and epilepsy... heal sores [Note that these disease conditions are simply examples of the purported benefits of your products.] In addition, your brochure references publications that purport to provide information about the benefits of velvet antler. When such publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 CFR (g)(2)(iv) (C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of reference citations from your website that are used to market your products for disease treatment and prevention and are thus evidence of your products intended use as drugs: Wang. 1985, 1988, claims that the polysaccharide content was responsible for the anti ulcer effect of velvet antler preparations. In some of the same studies [referring to certain studies on aging from Japan] it was noted that the peroxidation of lipids by free oxygen radicals, when treated with an ethanol extract of velvet antler, suppressed MDA synthesis in the liver of laboratory animals; suggesting that liver damage caused by free radicals could be alleviated with the use of the extract. We Told You So But Now it s Confirmed in the Medical Literature : As for deer antler itself, it s an age old remedy. Asians have benefited from its remarkable healing powers for at least two millennia. Ancient Chinese and 2/6

3 Korean scrolls report its value for at least 52 disease states... such as arthritis, headaches, vertigo and depression. Now research validates folklore, and in the case of arthritic joint damage, it does so with the blessing of the FDA.... [V]elvet antler does indeed... relieve and perhaps even cure arthritis... [and] correct sexual dysfunction.... The therapeutic effects of velvet antler... [include] anticancer effects.... The antler s cartilage components are anti inflammatory as well as possible anticancer agents.... Treatments suggested for osteoarthritis.... The anti ulcer effect has been attributed to its polysaccharide content. From the website tobinfarms.com [V]elvet antler an alternative supplement produced from Red Deer and Elk antlers that the Chinese and Koreans have been using over two thousand years for arthritis, blood disorders etc. Watch This Video!: it s good for lupus, fibromyalgia, osteoarthritis, osteoporosis, migraine headaches, varicose veins.in addition to arthritis, high blood pressure, high cholesterol, kidney and liver problems, it heals stomach ulcers. I suppose arthritis maybe, it hurt when I turned my head, after I d been taking those capsules for about two weeks, it didn t hurt anymore Tobin Farms in the Press and on TV : I was having a great deal of stiffness as a result of the chemotherapy we tried the velvet antler and it has been truly a godsend for me. We have customers taking them for gout any joint pain, lots of people have bad knees and they re taking them for their knee problems, knee pain Chronicle, Ch.5 Boston Similar Occurrence : I ve been using the product now for about 12 years and basically I take it for arthritic pain, joint pain and it s really changed the quality of my life by taking it 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), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating 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 product is 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, your Velvet Antler Capsules and Velvet Antler Powder fail to bear adequate directions for their intended use and, therefore, the 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 In addition, the claims on videos embedded in your website at tobinfarms.com establish that your Velvet Antler capsules and Velvet Antler powder 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. 3/6

4 Examples of some of the claims from videos on your website at tobinfarms.com that provide evidence that your products are drugs intended for use in animals include: Watch This Video!: it s good for osteoarthritis, osteoporosis...in addition to arthritis kidney and liver problems, it heals stomach ulcers. Made in Maine with Lou McNally on Maine PBS: She [dog shown in video] was hit by a car her hip was badly crushed the prognosis wasn t very good, the doctor said that she would probably suffer from arthritis and she wouldn t be able to use her leg very well we thought it would be a good idea if we just started putting some powder [deer antler] on her food and we did that on a regular basis within just a few months of her recovering she started using her leg and she was hopping around and running around like a young pup again. Because your 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)]. Adulterated Dietary Supplement Even if your Velvet Antler Capsules and Velvet Antler Powder were not unapproved new drugs and misbranded drugs, they would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet cgmp requirements for dietary supplements. Our inspection of your facility revealed serious violations of the FDA s regulations for Current Good Manufacturing Practice (cgmp) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). We acknowledge receipt of your October 13, 2016, response to the Form FDA 483, Inspectional Observations, issued to you on September 13, Your letter will be made a part of your firm s permanent record. However, while your response addresses your intent to establish and implement corrections to issues noted in the Form FDA 483, you did not provide any materials upon which we can evaluate the sufficiency of your corrective actions. Therefore, we will evaluate the sufficiency of your corrective actions during a subsequent inspection. The inspection identified the following violations: 1. Your firm failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (MMR), as required by 21 CFR Specifically, your firm does not maintain any written procedures for the manufacturing of your velvet antler products. In implementing a system of production and process controls, you must, among other requirements: a) Establish and implement written procedures for the responsibilities of the quality control operations (see 21 CFR and 21 CFR ). b) Establish specifications for the identity, purity, strength, composition and limits on potential contaminants for components, in process production, and finished product (see 21 CFR ). 4/6

5 c) Establish specifications for labels and packaging (see 21 CFR (g)). d) Collect and hold reserve samples of your production batches (see 21 CFR ). e) Prepare and follow a written MMR for each unique formulation that you manufacture, and for each batch size, to ensure uniformity of the batch from batch to batch (see 21 CFR ). f) Prepare batch production records every time you manufacture a batch of dietary supplement (see 21 CFR ). g) Establish and follow written procedures for packaging and labeling operations (see 21 CFR ). 2. Your firm failed to take effective measures to exclude pests from the physical plant and to protect against contamination of components, dietary supplements, and contact surfaces on the premises by pests, as required by 21 CFR (d)(2). Specifically, our investigators observed numerous live and dead moths in your manufacturing area, including in raw materials used to manufacture your dietary supplements. Additionally, FDA laboratory analysis confirmed the presence of live and dead moth larvae from a sample collected from in process products and materials associated with your firm s processing equipment. 3. Your firm failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR Specifically, you have no written procedures for investigation of a product complaint. 4. Your firm failed to establish and follow written procedures for fulfilling the requirement for equipment and utensils, including written procedures for maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements as required by 21 CFR Specifically, you do not have any written procedures for equipment and utensils. 5. Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR Specifically, you have no written procedures for holding and distributing operations. 6. Your firm failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR Specifically, you do not have written procedures for returned dietary supplements. 7. Your firm failed to provide hand washing facilities that are designed to ensure that an employee s hands are not a source of contamination of components, dietary supplements, or any contact surface, by providing facilities that are adequate, convenient, and furnished with running water at a suitable temperature, as required by 21 CFR (i). Specifically, your facility has no hand washing facilities. Insanitary Conditions Even if your Velvet Antler Capsules and Velvet Antler Powder were not unapproved new drugs and misbranded drugs, they would be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. FDA laboratory analysis confirmed the presence of live and dead moth larvae from a sample collected from in process products and materials associated with your firm s processing equipment. These findings cause your food products to be adulterated within the meaning of section 402(a)(4) of the Act Misbranded Dietary Supplement Even if your Velvet Antler Capsules and Velvet Antler Powder were not unapproved new drugs and misbranded drugs, they would be misbranded dietary supplements, as described below: 5/6

6 1. Your Tobin s Farm brand Velvet Antler, powder and capsule, products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(f)) in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR The Supplement Facts panel for both products does not list any dietary ingredient nor do they include the required headings of Amount per Serving and % Daily Value. 2. Your Tobin s Farm brand Velvet Antler capsule product is misbranded within the meaning of section 403(i)(2) of the Act in that the products label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4(a) and (g). For example, capsules are required to be identified as Other ingredients and be listed outside and immediately below or contiguous and to the right of the Supplement Facts panel. For your capsule product, you list gelatin capsule as a part of the serving size within the Supplement Facts panel. 3. Your Tobin s Farm brand Velvet Antler powder product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the serving size declared on the 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 (b) Table 2. Your Supplement Facts panel shows a serving size of 1 Gelatin Capsule and your Suggested Use states to Begin with 1 or 2 capsules per day however, this product is not encapsulated. As such, your label fails to declare an appropriate serving size. 4. Your Tobin s Farm brand Velvet Antler powder product is misbranded within the meaning of Section 403(q)(1)(B) because the label fails to list the servings per container under the serving size on the left hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR (b)(1)(ii). 5. Your Tobin s Farm brand Velvet Antler powder product is misbranded within the meaning of 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the label fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, as required by 21 CFR The product label does not declare the net quantity of contents in avoirdupois pound and ounce, only in metric quantity. 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 you re your firm complies with all requirements of federal law, including 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. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Further, Section 743 of the Act, 21 U.S.C. 379j 31, authorizes FDA to assess and collect fees to cover FDA s costs for certain activities, including reinspection related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection related costs means all expenses, including administrative expenses, incurred in connection with FDA s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees, 21 U.S.C. 379j 31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for reinspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection related costs. 6/6