Craigslist

South Pork Ranch Equipment LLC – 642420 – 09/20/2022


Delivery method:
By email
Product:
Animal & Veterinary
Drugs


Recipient:

Recipient’s 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

Object: 642420

Dear James Fuller:

This letter concerns your company’s marketing of animal drugs not approved for the treatment of diseases in animals, including but not limited to Cydectin (moxidectin), Cydectin (moxidectin) with iron supplement Blackstrap and Blackstrap. The United States Food and Drug Administration (FDA) reviewed your account, “goatandchickenman”, at https://www.ebay.com/usr/goatandchickenman, and Craigslist at https ://dallas.craigslist .org in August 2022 and determined that you distribute these products on these websites. Claims on your accounts at the listed websites establish that your products Cydectin, Cydectin with Iron Supplement Blackstrap, and “Blackstrap” are drugs under Section 201(g)(1)(B) of the FD&C Act. [21 U.S.C. 321(g)(1)(B)], as these products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in animals. As explained below, these products are new, unapproved veterinary drugs and the introduction or introduction for delivery of these products in interstate commerce violates the Federal Drug and Cosmetic Act (FD&C Act).

You can find FD&C and FDA regulations through links on the FDA home page at www.fda.gov.

New drugs for adulterated animals
Examples of claims observed by the FDA on eBay and Craigslist that show the intended uses of your product “Cydectin Pour-On Cattle Dewormer” include, but are not limited to, the following:

From your eBay store webpage titled – “Cydectin cattle pour-on dewormer 250ml/cc current…” (https://www.ebay.com/itm/Cydectin-cattle-pour-on-dewormer-250 -ml-cc-Current Expiration-September-2023/183106132479)
• “Cydectin® – moxidectin – Pour-On for beef and dairy cattle – Antiparasitic”
• “South Pork Ranch Equipment – Cydectin 250ml (cc) – Pouring Cattle, 10cc per 220lbs body weight – Sheep and Goats –GIVE ORALLY1 cc per 20 lbs of body weight – Expiration date…”

From your eBay store webpage titled – “Cydectin pour-on Cattle Wormer 500ml. …” (https://www.ebay.com/itm/Cydectin-pour-on-Cattle-wormer-500-ml -Current-Expiry-Date-Sept-2023/182514449076)
• “South Pork Ranch Equipment, LLC – Cydectin 500ml (cc) – Pouring Cattle, 10cc per 220lbs body weight – Sheep and Goats –GIVE ORALLY1 cc per 20 lbs of body weight – Expiration date 10/2018_”

From your eBay store webpage titled – “Goat Medicine – 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 with anemia due to heavy worm infestation.”
• “Stomach worms can suck the goat’s blood, causing acute anemia and death when the goat appears healthy. The most common of these is Haemonchus contortus (most common in spring and summer.) Haemonchus infection can cause death in as little as a week when there is a heavy infestation, with few symptoms. In many cases, aggressive [sic] treatment with Cydectin dewormer and Blackstrap molasses will save the goat’s life.
• “It is recommended to treat a heavy infestation of worms with CYDECTIN…”
• “Medicine for goats – Cydectin dewormer + Blackstrap iron supplement”
• “Cydectin® – moxidectin – Pour-On for beef and dairy cattle – Antiparasitic”

From your eBay store webpage titled – “Goat Supplement [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, the [sic] treatment with Cydectin dewormer and Blackstrap molasses will save the goat’s life. We strongly 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 250ml (cc) – Iron supplement used in the treatment of goats suffering from anemia due to heavy worm infestation. – Give ORALLY, 1 cc per 20 lbs of body weight twice daily. day.

From your Craigslist listing titled – “Cydectin Dewormer (500ml) 50% Off Goats – Sheep – Cattle (Will Ship)…” (https://dallas.craigslist.org/dal/grd/d/terrell- cydectin-wormer-500-ml-50-off/7517963485.html)
• “Cydectin Dewormer (500ml) 50% Off Goats – Sheep – Cattle (Shipped) — $48”
• “Cydectin® – moxidectin – Pour-On for beef and dairy cattle – Antiparasitic”
• “500 cc (ml) same quantity sold at Tractor Supply for $99.99”
• PS – safe for pregnant ewes and “O” milk withdrawals.
• “tags: Sheep Goats Goats Cattle Nubians Nubians Alpines Alpines Hinds Deer Ewes Heifers Bull Bull Bull Bull Bull Dorper Dorper Dorper Dorper’s Goat Cows Cow cow Tractors cows cydectin wormer wormer wormer wormer”

The statements quoted above are supplemented by the Craigslist tags used to drive consumers to your listing via internet searches. Examples of labels for consumers looking for products to prevent or treat parasitic infections include: “cydectin” and “vermifuge”.

South Pork Equipment Cydectin and 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 efficacy of veterinary drugs as safe and effective for use under the conditions prescribed, recommended or suggested in 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 labeling must be consistent with the approved labeling in the application or index listing.

We acknowledge that there is an approved pour-on product for cattle marketed by the applicant under the trade name Cydectin® (moxidectin). It is not clear if what you are selling is the approved product that you have repackaged and relabelled. Either way, the Approved Product is not approved or labeled for use in sheep or goats or for oral administration, all uses listed on the labeling of the products you sell. We also note that on your eBay and Craigslist web pages you have photographs of your Cydectin product alongside the product and FDA-approved Cydectin® (moxidectin) product packaging, which may misleadingly imply that the product you are selling is the approved Cydectin®.

The products you distribute are not approved or listed by the FDA, nor are their labeling consistent with an approval, and therefore the products are not safe within the meaning of section 512(a) of the Act FD&C, [21 U.S.C. § 360b(a)]and tampered with under FD&C Section 501(a)(5) [21 U.S.C. § 351(a)(5)]. The introduction or delivery for entry 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 exhaustive 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 repetition or the occurrence of other violations. It is your responsibility to ensure that your business complies with all requirements of federal law, including FDA regulations. This letter informs you of our concerns and gives you the opportunity to respond to 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) business days of receipt of this letter, of the steps you have taken to remedy any breach. Include an explanation of each action taken to prevent recurrence of violations, along with copies of related documentation. If you cannot complete the corrective actions within fifteen (15) business days, indicate the reason for the delay and the time frame within which you will complete the correction. If you think your products are not in
violation of FD&C law, include your reasoning and any supporting information for our consideration.

Your response should be emailed to Dr. Vic Boddie at [email protected] If you have any questions about this letter, please contact Dr. Boddie at this address.

Sincerely,
/S/

Neal Bataller, ME, DVM
Director, Drug Compliance Division
Monitoring and Compliance Office
Center for Veterinary Medicine

.

#South #Pork #Ranch #Equipment #LLC

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