When United States Congress passed the Dietary Supplement Health Education Act (DSHEA) in 1994, they failed to consider the potential application and benefits of supplements for animals. The Food and Drug Administration, Center for Veterinary Medicine (FDA-CVM) published a notice in the Federal Register stating that due to the lack of specific references to animals, DSHEA did not apply to products for animals. Consequently, there are only two categories under existing US law for these types of products, determined by their intended use:
“SEC. 201. [21 U.S.C. 321] Definitions; generally for the purposes of this Act
Food(Animal Food/Feed) – (f) 1 The term ‘food’ means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
Drug (Animal Drugs) – “(g)(1) The term ‘drug’ means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).”
This means that animal supplements, if they are not intended to provide nutrition to animals, are considered by the FDA to be unapproved drugs; therefore, safety and effectiveness for their intended use in specific species has not been evaluated by the agency. For a product to be an “approved” drug, a company must submit a New Animal Drug Application (NADA) with safety, efficacy and quality data that are then evaluated by the agency. Meeting this burden of proof is impossible for animal supplements.
The time required to develop a new animal drug can be between six to eight years with an investment of approximately $100 million, so submitting the data and information required to receive approval is both time consuming and very costly. For a company to afford it, it must accomplish at least two things: recover its investment, which is reflected in the price it charges for the products, and try to protect the business opportunity by patenting the product as a barrier to competitors.
Allowable product claims
Labeling claims are probably the most misunderstood and misused aspect of animal supplement regulation. Under current US law, products marketed for animals that are similar to human dietary supplements have only two legal categories: animal food/feed or animal drugs. Depending on their intended use, products may be considered unapproved animal drugs that may be marketed under enforcement discretion. Examples are supplements with ingredients supporting joint function, or herbal ingredients with a functional supportive purpose other than flavoring.
Labeling generally includes, but may not be limited to, product labels, product literature, websites, advertising and trade show materials, such as booth graphics.
Claims for natural health products for animals may be allowed by FDA-CVM if they are not in violation of those associated with approved animal drugs, and are limited to supporting the normal, healthy structure and/or function of the animal. Further information on labeling claims can be found in Labeling Claims, General Information on the FDA website; however, this guidance applies to nutritional products and human dietary supplements, and should only be viewed as general claims guidance.
Claims that sound too good to be true probably are. Any company that makes claims for natural products and mentions disease is an egregious violator, unless the company can provide a letter of non-objection from FDA-CVM.
Many drugs and medical devices are not approved for animals
When discussing supplements for animals, it is worthwhile to compare products and equipment used without question every day by veterinarians. Drugs — How many drugs on pharmacy shelves in every veterinary clinic and hospital are specifically approved for use in animals? An estimated 50% to 70% of drugs used every day by veterinarians are off-label or extralabel use, and have not met the criteria for safety and efficacy for animals.
Why are these drugs allowed to be sold by the FDA? The Code of Federal Regulations states: “530.30 Extralabel drug use in nonfood animals. (a) Because extralabel use of animal and human drugs in nonfood-producing animals does not ordinarily pose a threat to the public health, extralabel use of animal and human drugs is permitted in nonfood-producing animal practice except when the public health is threatened.”
It is a risk-versus-benefit analysys; if extralabel drug use was not allowed, veterinarians would have far fewer drugs to choose from in treating their patients and veterinary medicine would not have made the advances it has. If safety and efficacy data were required for all current drugs used to treat animals, veterinarians simply could not treat patients effectively.
Medical devices – In human medicine, there is an “approval” process for medical devices, typically referred to as the 510K process. Depending on the class of device, the requirements may be more or less rigorous. When a company wants to market a medical device for human use, it typically submits a documentation packet to FDA; when successful, it receives a letter granting permission to market the product. The FDA states the company has satisfied the requirements and they have no further questions. Human devices, or drugs for that matter, are not technically “approved” by FDA; the agency essentially grants permission to market products.
What products would require 510K submissions evaluating safety and effectiveness? Anesthesia machines/vaporizers, pulse oximeters, CO2 monitors, endotracheal tubes, IV pumps, IV tubing, anesthesia circuits…almost every medical device in a human hospital or clinic requires some type of evaluation by FDA prior to being legally marketed. The FDA-approval process and requirements for animal medical devices are virtually non-existent In comparison to human medicine. If all animal medical devices used by veterinarians were eliminated in cases where safety and efficacy have not been evaluated, almost all of them would no longer be available.
If the majority of drugs for animals have not been evaluated for safety and efficacy, and there is no approval process for animal medical devices, why don’t thousands of animals die? The reasons are:
1. The products have been used by people without causing significant “harm to public health”.
2. Regulatory agencies utilize risk-based approaches to allocate resources that serve the best interests of public safety and health. The products are allowed to be marketed under FDA enforcement discretion, provided the industry is acting responsibly.
In Part 2 of this article, which will appear in our next issue, we will look at how the animal supplement industry is working with regulatory agencies, and the important role the National Animal Supplement Council (NASC) plays in regulating natural health products for animals.
Federal Food Drug & Cosmetic Act, SEC. 201. [21 U.S.C. 321], CHAPTER II—DEFINITIONS, SEC. 201. [21 U.S.C. 321] Definitions; generally For the purposes of this Act. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.htm
Requirements for New Animal Drug Applications. http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/NewAnimalDrugApplications/default.htm Small Animal Clinical Pharmacology, Jill E. Maddison, Stephen W. Page, pp. 20-22.
National Animal Supplement Council, FAQs. http://nasc.cc/index.php?option=com_content&task=view&id=29&Itemid=38
FDA, Labeling Claims, General Information. http://www.fda.gov/Food/LabelingNutrition/LabelClaims/default.htm
Extralabel drug use in animals. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=530
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm165062.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm208978.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm212363.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm215443.htm