WARNING LETTER
South Pork Ranch Equipment LLC
MARCS-CMS 642420 —
September 20, 2022
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
James Fuller
Recipient Title
eBay account: goatandchickenman
South Pork Ranch Equipment LLC
(b)(6)
United States
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
September 20, 2022
RE: 642420
Dear James Fuller:
This letter concerns your firm’s marketing of unapproved animal drug products for the treatment of disease in animals, including but not limited to, Cydectin (moxidectin), Cydectin (moxidectin) with Blackstrap Iron Supplement, and Blackstrap. The U.S. Food and Drug Administration (FDA) has reviewed your account, “goatandchickenman”, at the internet address https://www.ebay.com/usr/goatandchickenman, and Craigslist listing at the internet address https://dallas.craigslist.org in August 2022 and have determined that you distribute these products on these websites. The claims on your accounts on the listed websites establish that your Cydectin, Cydectin with Blackstrap Iron Supplement, and “Blackstrap” products are drugs under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)], because these products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. As explained further below, these products are unapproved new animal drugs and introducing or introduction for delivery of these products into interstate commerce violates the Federal Food Drug and Cosmetic Act (FD&C Act).
You can find the FD&C Act and FDA regulations through links on FDA’s homepage at
www.fda.gov.
Adulterated New Animal Drugs
Examples of claims FDA observed on eBay and Craigslist that show the intended uses of your “Cydectin cattle pour-on dewormer” product includes, but may not be limited to, the following:
From your eBay store webpage titled – “Cydectin cattle pour-on dewormer 250 ml/cc Current …” (https://www.ebay.com/itm/Cydectin-cattle-pour-on-dewormer-250-ml-cc-Current-expiration-Sept-2023/183106132479)
• “Cydectin® - moxidectin - Pour-On for Beef and Dairy Cattle - Antiparasitic”
• “South Pork Ranch Equipment – Cydectin 250 ml (cc) – Cattle-Pour-On, 10cc per 220 lbs body weight – Sheep & Goats-
GIVE ORALLY
, 1 cc per 20 lbs body weight – Expiration Date… ”
From your eBay store webpage titled – “Cydectin pour-on Cattle wormer 500 ml. …” (https://www.ebay.com/itm/Cydectin-pour-on-Cattle-wormer-500-ml-Current-expiration-Date-Sept-2023/182514449076)
• “South Pork Ranch Equipment, LLC – Cydectin 500 ml (cc) – Cattle-Pour-On, 10cc per 220 lbs body weight – Sheep & Goats-
GIVE ORALLY
, 1 cc per 20 lbs body weight – Expiration Date 10/2018_”
From your eBay store webpage titled – “Goat medication - Cydectin dewormer + Blackstrap Iron Supplement” (https://www.ebay.com/itm/Goat-medication-Cydectin-dewormer-Blackstrap-Iron-Supplement/184241021511)
• “Blackstrap as an iron supplement is very effective in treating Goats suffering anemia due to a heavy WORM infestation.”
• “Stomach worms can suck the blood of the goat causing acute anemia, and death when the goat appears to be in good health. The most common of these is Haemonchus contortus (most common in spring and summer.) An infection of Haemonchus can cause death in a short a time as one week when there is heavy infestation, with few symptoms. In many cases, agressive [sic] treatment with Cydectin dewormer and Blackstrap molasses will save the life of the Goat.”
• “It's recommended that heavy worm infestation be treated with CYDECTIN…”
• “Goat medication - Cydectin dewormer + Blackstrap Iron Supplement”
• “Cydectin® - moxidectin - Pour-On for Beef and Dairy Cattle - Antiparasitic”
From your eBay store webpage titled – “Goat Suppliment [sic] / Quickly rebuilds blood level loss due to worm infestation” (https://www.ebay.com/itm/Goat-Suppliment-Quickly-rebuilds-blood-level-loss-due-to-worm-infestation/184251657733)
• “In many cases, aggressive [sic] treatment with Cydectin dewormer and Blackstrap molasses will save the life of the Goat. We highly recommend the use of Cydectin dewormer with this product.”
• “Blackstrap is used to quickly rebuild blood but IS NOT used to deworm.”
• “South Pork Ranch Equipment – Blackstrap 250 ml (cc) – Iron Supplement used in the treatment of GOATS suffering anemia due to a heavy worm infestation. – Give ORALLY, 1cc per 20lbs body weight twice a day.”
From your Craigslist listing titled – “Cydectin wormer (500 ml) 50% Off goats – sheep – cattle (Will ship)…” (https://dallas.craigslist.org/dal/grd/d/terrell-cydectin-wormer-500-ml-50-off/7517963485.html)
• “Cydectin wormer (500 ml) 50% Off goats – sheep – cattle (Will ship) --$48”
• “Cydectin® - moxidectin - Pour-On for Beef and Dairy Cattle - Antiparasitic”
• “500 cc (ml) same quantity sell’s at Tractor supply for $99.99”
• P.S. – safe for pregnant doe’s ewe’s heifer’s and “O” milk withdrawal.”
• “tags: Sheep Goats goat Cattle Nubian Nubian Alpine alpine Doe’s doe Ewe’s Heifer’s bull bull’s Bull’s Bull bull’s Dorper dorper Dorper’s dorper’s Goat cows Cows cow Cow tractors cydectin dewormer Dewormer wormers Wormer”
The claims quoted above are supplemented by the Craigslist tags used to bring consumers to your listing through Internet searches. Examples of the tags targeted to consumers who are looking for products to prevent or treat parasitic infections include: “cydectin” and “dewormer.”
South Pork Equipment Cydectin and blackstrap molasses products are new animal drugs, as defined by section 201(v) of the FD&C 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. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. In addition, the drug product’s labeling must conform to the labeling approved in the application or index listing.
We acknowledge that there is an approved pour-on product for cattle marketed by the application holder under the trade name Cydectin® (moxidectin). It is not clear if what you are selling is the approved product that you have repackaged and relabeled. Regardless, the approved product is not approved or labeled for use in sheep or goats or for oral administration, all uses listed in the labeling for the products you sell. We note also that on both your eBay and Craigslist webpages you have photographs of your Cydectin product alongside the FDA approved Cydectin® (moxidectin) product and product packaging, which may misleadingly imply that the product you are selling is the approved Cydectin®.
The products you are distributing are not approved or index listed by FDA, and their labeling does not conform to an approval and, therefore, the products are unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all the requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to address any 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 the corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in
violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent via e-mail to Dr. Vic Boddie at CVMUnapprovedDrugs@fda.hhs.gov. If you have any questions about this letter, please contact Dr. Boddie at that address.
Sincerely,
/S/
Neal Bataller, ME, DVM
Director, Division of Drug Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine
Content current as of:
10/18/2022
Regulated Product(s)
Animal & Veterinary
Drugs