Tobin's Royal Stag, Inc. dba Tobin Farms Velvet Antler - 508553 - 04/19/2017
- Animal & Veterinary
- Tobin's Royal Stag, Inc. dba Tobin Farms Velvet Antler
- Issuing Office:
- New England District Office
New England District Office (NWE-DO)
One Montvale Avenue, 4th floor
Stoneham, MA 02180
- 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”
- “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.]
- “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 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.”
- “[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…”
- “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…”.
- 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 111.55. 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:
- 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 111.15(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.
- Your firm failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you have no written procedures for investigation of a product complaint.
- 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 111.25. Specifically, you do not have any written procedures for equipment and utensils.
- Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have no written procedures for holding and distributing operations.
- Your firm failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, you do not have written procedures for returned dietary supplements.
- 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 111.15(i). Specifically, your facility has no hand-washing facilities.
Misbranded Dietary Supplement
- 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 101.36. 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.”
- 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.
- 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 101.12(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.
- 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 101.36(b)(1)(ii).
- 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 101.7. The product label does not declare the net quantity of contents in avoirdupois pound and ounce, only in metric quantity.