WARNING LETTER
Nutrition Strength Ltd.
MARCS-CMS 696350 —
November 12, 2024
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Recipient:
Nutrition Strength Ltd.
Bulgaria
pets@nutritionstrength.com
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
November 12, 2024
Re: 696350
This letter concerns your firm’s marketing of unapproved new animal drugs, including Dog Seizure and Epilepsy Supplement and Blood Support for Dogs for the treatment of diseases in animals, in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) reviewed your website, www.nutritionstrength.com from October to November 2024, where you promote your products, and offer these products for sale in the United States through hyperlinks on your website www.nutritionstrength.com, which directs consumer to www.amazon.com/dp/B07HY4QRWX and www.amazon.com/Nutrition-Strength-Supplement-Promotes-Spirulina/dp/B07G9HTPNH, respectively for purchase.
Based on our review, the claims on your website, product labeling, and linked Amazon webpages establish that your Dog Seizure and Epilepsy Supplement and Blood Support for Dogs products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or to affect the structure or function of the body of animals.
Your product’s names, such as Dog Seizure and Epilepsy Supplement and Blood Support for Dogs, indicate they are intended for use in treating animals with disease conditions and/or to affect the structure or function of the body of animals.
You can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov.
Examples of claims FDA observed on your product labeling and product listing webpages that show the intended use of your products include, but are not limited to, the following:
Dog Seizure and Epilepsy Supplement
• On your webpage titled “Epilepsy in Dogs: How to Protect Your Pet” at the URL https://www.nutritionstrength.com/epilepsy-in-dogs-how-to-protect-your-pet:
o “A natural way to protect against dog seizures and epilepsy…”
o “Supporting your pet’s defensive systems to make it less likely that they suffer from epileptic attacks.”
o “Assisting in controlling and manage epileptic seizures when they do occur.”
o “Facilitating a healthy recovery from epileptic fits and helping to limit the damage from them.”
o “…promote balanced behavior in your dog and to limit nervous outbursts.”
o “…helps to soothe your pet’s nerves, while simultaneously promoting a balanced nervous system, healthy brain functioning and stability to help them deal with dog seizures and stress-related issues, such as separation anxiety, thunderstorms, fireworks and other loud noises, trips to the vet, car rides, changes in routine, dog parks and crowded public spaces.”
• The image of your product label found on https://www.nutritionstrength.com/epilepsy-in-dogs-how-to-protect-your-pet and https://www.amazon.com/dp/B07HY4QRWX states:
o “Supports a balanced nervous system and promotes a health recovery”
o “Formulated to naturally help:
-Reduce the frequency of seizures
-Control and manage epileptic fits
-Limit the damage from attacks”
Blood Support for Dogs
• On your webpage titled “Anemia in Dogs: What You Need to Know” at the URL https://www.nutritionstrength.com/anemia-in-dogs-what-you-need-to-know:
o “…specially made for pregnant dogs, active dogs, dogs suffering from anemia, substantial blood loss, weakness and tiredness after surgical stress and birthing recovery, as well as parasite infestation.”
o “…help your pets by…furnishing folic acids, whose deficiency may lead to problems such as anemia.”
o “…may help increase the levels of hemoglobin, which in turn may raise the oxygen level in the body and help raise your dog’s energy level.”
These products are "new animal drugs" under 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, new animal drugs must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under section 512, 571, or 572 of the FD&C Act, 21 U.S.C. § 360b, 360ccc, or 360ccc-1, respectively. These products are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing by the FDA, and therefore are considered unsafe under 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)].
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and/or injunction.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products or operations. Our review of your website indicates that you are offering for sale unapproved animal drugs in addition to those listed above. If FDA takes legal action, the action may address all of your unapproved new animal drugs, not just those listed above. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA’s implementing regulations.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps 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 action 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.
Please direct your response to the U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance, by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 696350” in the subject line of your email.
Sincerely,
/S/
Neal Bataller, ME, DVM
Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Content current as of:
01/07/2025
Regulated Product(s)
Animal & Veterinary
Drugs