WARNING LETTER
Desert Defense, LLC
MARCS-CMS 650718 —
January 26, 2023
Product:
Animal & Veterinary
Recipient:
Recipient Name
Randall Thomason and Jane Laulis
Desert Defense, LLC
31390 North 59th Street
Cave Creek
,
AZ
85331-3056
United States
info@desertdefense.com
Issuing Office:
Center for Veterinary Medicine
United States
January 26, 2023
Rogue Research, LLC
4025 East Huntington Drive
Suite 125
Flagstaff, Arizona 85255
United States
Re: 650718
Dear Randall Thomason and Jane Laulis:
This letter concerns your firm’s marketing of unapproved new animal drug products for the treatment of disease in animals, including but not limited to, “Desert Defense Original Formula, Yeast, Fungal & Mold Support, and SuperBo Wellness Formula”. The U.S. Food and Drug Administration (FDA) has reviewed your website at the internet address www.desert-defense.com and www.rogueresearch.com/ in November and December 2022 and has determined that you distribute this product there. We have also reviewed your social media website at https://www.facebook.com/Desert.Defense.Valley.Fever/ where you direct consumers to your website at www.desert-defense.com to purchase products.
Based on our review of your website and social media, your “Desert Defense” products are a drug under section 201(g)(1)(B) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)(B)], because this product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. As explained further below, these products are an unapproved new animal drug and introducing or delivering these products for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
You can find the FD&C Act and FDA regulations through links on FDA’s homepage at
www.fda.gov.
1. Examples of claims observed on your www.desert-defense.com website that show the intended uses of your “Desert Defense” products include, but may not be limited to, the following:
From your website www.desert-defense.com: Webpage titled – “Desert Defense Dogs | A First Line of Defense Against Valley Fever for Your Dog”
“A First Line of Defense Against Valley Fever for Your Dog”
“Desert Defense provides nutritional support for prevention or active cases of Valley Fever.”
“Desert DEFENSE™ for Dogs was designed and tested to boost your dog’s natural defenses against the unique host of fungal, parasitic, viral and bacterial pathogens that flourish in the desert southwest.”
“Desert DEFENSE™ | A Multi-Nutrient Formula For Dogs | A Holistic Defense Against | VALLEY FEVER | and other pathogenic invaders”
From your website www.desert-defense.com: Webpage titled – “Internet Orders | Desert Defense Dogs”
“
Level 1: Original
– this is for dogs with active Valley Fever infections and can be used for preventative support but we prefer Level 2 for that. You may use this product with drugs with your vet’s approval and also as support to minimize the relapse cycle as your dog goes off drugs.”
Level 2: Yeast, Fungal & Mold Support
– this is for preventive support, mild to moderate cases of Valley Fever and intact canines. If you are visiting Arizona use this for support at lower doses for protection.”
Level 3: SuperBotanical Wellness
– this is for dogs that are mature and have lived in the prime Valley Fever conditions without issues for year and senior pets. It is very mild.”
“Desert Defense Original Formula $59.95 plus shipping 157 gm 5.5 oz Green label. This is our Original formula .... This formula is most appropriate for dogs that are sick and have lethargy as one of the issues. DD Original is our strongest formula. DD Original has been clinically tested and have been proven to reduce titers and symptoms in dogs suffering for Valley Fever.”
From your website www.desert-defense.com: Webpage titled – “Desert Defense Dogs… Products”
“
Level 1: Original
– this is for dogs with active Valley Fever infections and can be used for preventative support but we prefer Level 2 for that. You may use this product with drugs with your vet’s approval and also as support to minimize the relapse cycle as your dog goes off drugs.”
“NEW PRODUCT: ORIGINAL STAGE 2 – The same strong product as Original but for dogs that do not have lethargy as an issue.”
“Level 2: Yeast, Fungal & Mold Support – this is for preventive support, mild to moderate cases of Valley Fever and intact canines. If you are visiting Arizona use this for support at lower doses for protection.”
“Level 3: SuperBotanical Wellness – this is for dogs that are mature and have lived in the prime Valley Fever conditions without issue for years and senior pets. It is very mild.”
“
ORGANIC ORIGINAL FORMULA
5.5 and 11 oz sizes | This is our Original formula …. This formula is most appropriate for dogs that are sick and have lethargy as one of the issues. DD Original is our strongest formula so we do not recommend this for maintenance. Instead use one or the other of the products listed above. DD Original has been clinically tested and has been proven to reduce titers and symptoms in dogs suffering from Valley Fever.”
From your website www.desert-defense.com: Webpage titled – “FAQS & BLOG | Desert Defense Dogs”:
“Postings on 12/18/12: Q: My dog has Valley Fever and my vet is recommending fluconazole. Is it safe to use your product? A: First always check with your veterinarian before introducing any supplementation in combination with a drug program. We did develop Desert Defense to be used in conjunction with fluconazole. In some cases it seems that it might greatly enhance the absorption of the drug. WE [sic] still always recommend a very slow loading period at small amounts to ensure no adverse reactions. We have had numerous reports from veterinarians and pet owners that the addition of Desert Defense vastly improved symptoms and titers.”
"Q: Does Desert Defense prevent Valley Fever? A: We developed this product as support for dogs with active cases of Valley Fever. It is virtually impossible for us to determine if it actually prevents Valley Fever… What we are trying to do is provide your dog as many tools as possible to keep a strong, sound immune system.”
“Q: Should I use Sensitive or the Original formula for my dog? A: Initially we had one formula. … So the best recommendation is that if your dog is “sick” with Valley Fever please use the Original formula with your Veterinarian’s approval. If your dogs are exposed and carrying a titer then please use either Sensitive (now called Yeast, Fungal & Mold Support) or our new SuperBo/Basic formulas.”
2. Examples of claims observed on your www.rogueresearch.com/ website that show the intended uses of your “Desert Defense” products include, but may not be limited to, the following:
From your website www.rogueresearch.com: Webpage titled – “Rogue Research”:
“The First Line of Defense Against Valley Fever For Dogs!”
From your website www.rogueresearch.com: Webpage titled – “Desert-Defense
TM
for dogs..”:
“A dietary supplement to support the endocrine, immune, digestive and detoxification functions of dogs that are exposed to coccidioidomycosis aka valley fever and other fungal, parasitic, viral and bacterial pathogens that flourish in the desert southwest.*”
“Created for the potential to puncture lipid membranes of fungal cells”
“Reduce inflammation”
“Promote and deliver anti-fungal, anti-bacterial, and anti-viral activity”
3. From your social media website www.facebook.com/Desert.Defense.Valley.Fever: Webpage titled – “Desert Defense | Facebook”:
Your Facebook cover and profile photo states:
o “Desert Defense
TM
for dogs was designed and tested to boost your dogs natural defenses against the unique host of fungal, parasitic, viral, and bacterial pathogens that flourish in the desert southwest.”
o “A First Line of Defense Against Valley Fever…”
On February 24, 2020 you posted: “…She cared for him 24/7 and did research to find the best products to help him beat Valley Fever. One of the products she made sure he had every single day was Desert Defense!”
Comment on post from October 13, 2019 – commenter states, “We have not have [sic] one dog get Valley Fever since we started using it as a preventative in 2014.” Your response: “… such great news – thank you!”
On June 27, 2019 you posted: “…Desert Defense has kept all of our mastiffs free of Valley Fever all their lives. Can't do without it!"
On January 29, 2019 you posted: “This beautiful German Shorthaired Pointer lived to 15 years. ... When he was 8 he developed a Valley Fever titer and was placed on a holistic protocol based upon Desert Defense. He never went on any anti-fungal meds.”
On January 29, 2016 you posted: “Important information: frequently when pets first start showing symptoms of Valley Fever they do not register a titer and thus the reason for misdiagnosis and the wrong course of treatment. If your pet is showing any signs then start Desert Defense while you await the diagnostics!”
On October 24, 2017 you posted: “…He was diagnosed with giardia, eye infections, ear infections and valley fever. His titer was 1:256. His vet immediately put him on fluconazole and other meds for his eyes, ears, and stomach. We were unable to take him home until all but the valley fever had cleared up. On a recheck appointment with his vet, she suggested Desert Defense. … Another titer taken about a week ago showed he had gone from 1:256 to an amazing 1:32. We are certain, as is his vet, that the Desert Defense and his meds have made a tremendous difference and will continue with his treatments in the hope that he will someday not need them anymore.”
On September 16, 2016 you posted: “Important information: Another veterinarian taking a dog off of anti-fungal drugs and using only Desert Defense and the results are astonishing. We are hearing from more and more pet parents that it's their veterinarian that recommends DD.”
These 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. 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 FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. 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)].
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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 you comply with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action correct any violations. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction.
Within fifteen (15) working days of the receipt of this letter, please notify this office in writing of the steps that you have taken to correct 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 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 Vic.Boddie@fda.hhs.gov. If you have any questions or comments, please contact Dr. Boddie.
Sincerely,
/S/
Neal Bataller, ME, DVM, Director
Division of Drug Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine
Content current as of:
02/21/2023
Regulated Product(s)
Animal & Veterinary