Animal & Veterinary
UPDATE ON ANIMAL DIETARY SUPPLEMENTS
by Linda A. Grassie
FDA Veterinarian Newsletter 2002 Volume XVI, No III
Part of FDA's responsibility in enforcing the Federal Food, Drug, and Cosmetic Act (the Act) is to ensure that animal food is safe and properly labeled. FDA's Center for Veterinary Medicine (CVM) is responsible for enforcing this part of the Act. Dietary supplements, such as vitamins and minerals, fall into the category of animal feeds.
Dietary supplements for animals such as vitamin and mineral products have been marketed for many years. Most of these products include ingredients that are approved food additives, generally recognized as safe (GRAS) substances, or ingredients listed in the Official Publication of the Association of American Feed Control Officials (AAFCO).
Quite a few animal supplement products are being sold as a result of the Dietary Supplement Health and Education Act (DSHEA) passed by Congress in 1994, and these products generally contain similar ingredients to those in human dietary supplements. However, FDA published a notice in the Federal Register in 1996 explaining why the Agency believes that DSHEA does not apply to animals. Many of these types of products marketed for animals contain ingredients that may be unsafe food additives or unapproved new animal drugs, making the products unsafe for the animals.
CVM is concerned about these products because we do not have scientific data to show that they are safe or even contain the ingredients listed on the label. This article describes CVM's authority and concerns about certain animal dietary supplements, and what companies can do legally to market their products.
In addition to enforcing the provisions of the Act designed to ensure that animal food is safe and properly labeled, CVM is also responsible for ensuring that animal drugs are safe, effective, and can be manufactured to a consistent standard. Safety includes drug safety for the animals, environment, and for people who consume animal-derived products. Animal dietary supplements can fit under the definition of food, drug, food additive, or GRAS substance. These terms are defined in the Act as follows:
FOOD - The Act defines food as "articles used for food or drink for man or other animals...and articles used for components of any such article." There is no requirement that animal foods have pre-market approval by CVM. The Act does require that animal foods, like human foods, be pure and wholesome, contain no harmful or deleterious substances, and be truthfully labeled.
DRUG - The Act defines a drug, in part, as "an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or an article intended to affect the structure or function of the body other than food." In the drug definition, the courts have interpreted "food" as something that provides nutrition, taste, or aroma. If a food affects the structure or function of the body, it does so by these properties (for example, a food may provide nutrients such as calcium for proper bone structure). However, if a substance affects the structure or function of the body apart from its nutritive value, such as improvement in joint function, it may be considered a drug. Structure/function effects extending beyond the "food" umbrella also include claims for improved or increased production and performance, or alteration or improvement in function.
When a substance, including one considered food, is intended to be used for the treatment or prevention of disease or for a "non-food" structure/function effect, FDA considers it a drug. Under the Act, a new animal drug must be shown to be safe and effective for its intended use by adequate data from controlled scientific studies as part of a New Animal Drug Application (NADA). If a product on the market is not approved, it may be deemed an adulterated drug and subject to regulatory action.
FOOD ADDITIVE - In 1958, Congress amended the Act to require the pre-market clearance of additives whose safety was not generally recognized. The Act was also amended to deem food unsafe and adulterated if it contains an unapproved food additive. A food additive petition is the pre-clearance mechanism developed by the FDA for demonstrating that a food additive is safe for its intended use and has utility. If the FDA agrees with the petition, a regulation is published in the Federal Register and the additive is added to the Code of Federal Regulations.
GRAS SUBSTANCE - The Act also states that substances added to food that qualified scientists generally recognize as safe (GRAS) under the conditions of the intended use are not "food additives" and as such are exempt from pre-clearance approval. A GRAS substance is GRAS only for an intended purpose. For example, sodium aluminosilicate is GRAS as an anticaking agent. It has been purported to bind mycotoxins and prevent absorption from the intestinal tract, but is not GRAS for this use. A food substance also cannot be GRAS for the prevention, treatment, or mitigation of a disease. So, chondroitin sulfate cannot be GRAS to prevent or treat arthritis. For this use this ingredient would be a drug.
CVM has used regulatory discretion and has not required food additive petitions for some substances that do not raise any safety concerns. In these cases, we ask the company to submit the information needed to be listed in the AAFCO Official Publication. AAFCO is an association that includes officials from all States, Canada, Costa Rica, and the Federal government who are responsible for enforcing the laws regulating the production, labeling, distribution, and/or sale of animal feeds. One of AAFCO's main goals is to provide a mechanism for developing and implementing uniform and equitable laws, regulations, standards, definitions, and enforcement policies for animal feeds. In regulating animal feeds, CVM often works with AAFCO.
AAFCO INGREDIENT DEFINITION - This ingredient definition process is done to conserve CVM resources, as food additive approval is time-consuming. CVM reviews the data to ensure the ingredient has utility and can be manufactured consistently to meet product specifications. Although ingredients used under regulatory discretion are still unapproved food additives, CVM agrees that it will not take regulatory action as long as the labeling is consistent with the accepted intended use, the labeling or advertising does not make drug claims, and that new data are not received that raise questions concerning safety or suitability.
DSHEA: Does Not Apply to Animal Supplements
When Congress enacted the DSHEA in 1994, it created a new category of substances and new regulatory scheme. The Act was amended to define a dietary supplement as a product intended to supplement the diet and that contains at least one or more of the following ingredients: a vitamin; a mineral; a herb or other botanical; an amino acid; a dietary substance for use to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract or combination of any of the previously mentioned ingredients. The main effect of DSHEA was to remove certain dietary ingredients from regulation as food additives, which require pre-market approval.
As mentioned above, in April 1996, CVM published a notice in the Federal Register outlining the reasons why FDA believes that DSHEA does not apply to substances for use in animals. This has been upheld in at least one court case. Thus, substances marketed as dietary supplements for humans still fall under the pre-DSHEA regulatory scheme when marketed for animals; that is, they are considered food, food additives, new animal drugs, or GRAS depending on the intended use. Most of these types of products on the market would be considered unapproved and unsafe food additives or new animal drugs based on current intended uses. While these products are technically in violation of the law, they are of low enforcement priority except for when public or animal health concerns arise.
Why is CVM concerned about some dietary supplements marketed for animals?
CVM's concerns about certain dietary supplements focus on three main areas:
- Human food safety - supplements that are used in food animals, including horses that are used for food, must be shown to be safe for people who consume products from the animals. Without these data, there is no assurance that animal-derived food is safe.
- Animal safety - supplements must be shown to be safe to the animals. CVM and AAFCO have not received data showing that these products have actually been tested on animals to show that a particular level is appropriate or safe for the animals.
- Manufacturing quality - supplements must be shown to be manufactured to a consistent standard (for example, shown to contain a given amount of the ingredient).
In addition, some of these products are being marketed to treat or prevent disease. This moves them from the supplement category into the drug category. CVM is concerned that these products have not been shown to be safe and effective. And, some owners may be using these products in lieu of obtaining appropriate veterinary treatment for their animals.
How can companies legally market animal dietary supplement products?
- They can check the list of approved food additives and GRAS substances in Title 21, Part 570 - 584 of the Code of Federal Regulations.
- They can check the list of ingredient definitions in the Official Publication of the Association of American Feed Control Officials.
If the ingredient they propose to use in their product is not on either list, they can submit a Food Additive Petition or the information needed to list the ingredient in the AAFCO Official Publication. Companies may visit the AAFCO web site and contact the appropriate AAFCO investigator. Another option would be for them to contact the control officials within their State. Contact information for the AAFCO investigators and State Feed Control Officials may be found on the AAFCO website.
If companies wish to market a new animal drug, they can submit a New Animal Drug Application (NADA) with CVM. Information on submitting NADAs may be found on the CVM Home Page.
Linda Grassie is a former Deputy Director of CVM's Communications Staff.