Herbs, Botanicals and Novel Ingredients
Due to an increasing consumer focus on healthy living and increased longevity, the pet industry has introduced a plethora of pet supplements over the last few years. Many of these products contain ingredients, which are Generally Recognized As Safe (GRAS) or otherwise approved by the US Food and Drug Administration (FDA) and/or the Association of American Feed Control Officials (AAFCO). These products are often registered within the states they are marketed and comply with state and federal regulations. Often the products do not make therapeutic claims except to the extent that they assist in digestion, aid in the absorption of nutrients, or provide added vitamins and minerals to the animal's diet.
However, other products contain novel ingredients, herbs or botanicals, which may not be approved for inclusion in pet food. These products, known variously as "nutraceuticals," "novel ingredients," "herbs and botanicals," and "functional foods," are intended to supplement a pet's diet in order to provide valuable therapeutic benefits without being necessarily a requirement for good nutrition or acting as drugs. The list of supplements that manufacturers might want to market, and in some cases do market, is exhaustive, and could include, but is not limited to, such ingredients as glucosamine, chondroitin, raspberry leaves, echinacea, burdock, nettle, ginseng, gingko as well as, numerous other substances. Supplements come in the form of ingredients to be added to pet food, treats, beverages, as well as, products closely mirroring dietary supplements for humans.
One of the more recent products to come onto the pet product marketplace are products containing CBD, hemp, cannabis or cannabis derivatives. Interest in these products increased when Congress passed the Agriculture Improvement Act of 2018 (the 2018 Farm Bill). Among other things, this law established a new category of cannabis classified as “hemp” – defined as cannabis and cannabis derivatives with extremely low (no more than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). The 2018 Farm Bill removed hemp from the Controlled Substances Act, which means that it is no longer a controlled substance under federal law. At the same time, Congress explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.
The FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce. Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements. This is because CBD and THC are active ingredients in FDA-approved drug products and were the subject of substantial clinical investigations before they were marketed as food. In such situations, with certain exceptions that are not applicable here, the only path that the FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use.
FDA has announced (April 2019) that they intend to evaluate potential pathways for the regulation of cannibis products and have announced a public hearing on the issue, that they will form an internal working group, and that they intend to issue warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations. For more see the FDA Commissioner's announcement on cannabis products. Many states are also proposing laws and or regulations to regulate cannabis products. We await more updates on whether the regulation for CBD products in edible products versus supplements will differ.
Most of APPA members that manufacture dietary supplement products belong to the National Animal Supplement Council (NASC). For the most up to date information on ingredients, and the regulatory environment of dietary supplements for companion animals please see their Web Site or contact their President Bill Bookout.
APPA provides regular updates to its members regarding this issue and represents its members with AAFCO and its constituent groups. APPA researched the uniformity of state regulatory affairs on this issue, concluding that enforcement against these products varies amongst the states. That informal survey asked state regulators whether they follow the AAFCO enforcement strategy, as well as, what enforcement issues they regularly encounter. According to responses received the most prevalent enforcement issues facing state regulators are unauthorized drug claims, unapproved ingredients and failure to register or obtain licenses from the states.
If you would like to speak to APPA staff regarding nutraceuticals please phone Ed Rod, Associate VP of Government Affairs & General Counsel at (203) 532-3600 or e-mail at email@example.com.
Pet Food Ingredient Compliance
Manufacturers have a variety of procedures to gain permissive use of a given substance in pet food. These include food additive petitions ( 21 Code of Federal Regulations (CFR) Part 573 ) , GRAS status (21 CFR Part 582), or New Animal Drug Approvals through the US Food and Drug Administration or recognition by the Association of American Feed Control Officials based on inclusion in the AAFCO Feed Ingredients Definition list. As to be expected, these procedures each have virtues and disadvantages, and can be costly and time-consuming. In general, products whether pet food, treats or dietary supplements, cannot contain ingredients that are not approved or defined by a regulatory body. Therefore, regulators require and encourage manufacturers to pursue approvals before marketing begins. A summary of the types of ingredient approvals can be found in a FDA paper for Consumers entitled FDA's Regulation of Pet Food.
One of the more viable means of gaining approvals of feed ingredients is the AAFCO Ingredient Definition process whereby an industry representative submits data to the AAFCO Ingredients Definition Committee. After the necessary set of data is presented and accepted by the committee, and if the FDA has provided a letter of no objection, the ingredient is given a definition and included in the AAFCO listing in its Official Publication, which is updated and republished annually and is available by ordering from the AAFCO website . Although AAFCO is not a governmental body, AAFCO is comprised of state and federal feed officials; and, effectively has oversight over all animal feeds, including pet food. Substances not appearing in the AAFCO listing of approved ingredients are not allowed in pet food and other commercial feed in most states as individual states adopt the AAFCO rules and feed ingredient definitions by reference.
Noteworthy is the fact that achieving an ingredient definition for an herb product still will not permit any claims as to the product's use for therapeutic purposes to appear on its label. For example, if a proposal is made for an ingredient to be approved as a flavoring agent, it will be approved for that purpose only, if at all.
Unlike dietary supplement products for humans, the Dietary Supplement Health and Education Act (DSHEA), which provides for the marketing of novel ingredients, does not apply to products intended for animals. Sometimes the food product with an added novel ingredient will be considered both a drug and a food if the claims made for the intended use of that product are considered drug claims. A drug is defined as an article (other than food) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals. Diseases resulting from essential nutrient deficiencies would not be included in the definition, thus classifying the food as a drug. A food can make a claim to alter the structure or function of the body only as it relates to the product's taste, aroma or nutritive value. If a structure or function claim is made on an animal food product to indicate that it will prevent a disease that is not a nutrional deficiency, the FDA wil interpret that claim as a drug claim. The FDA's Program Policy and Manual Guide 1240.3605, Regulating Animal Foods with Drug Claims, provides the matrix used by the FDA to determine whether a product is to be classified as a drug.
In 2016 the FDA issued a Compliance Policy Guide entitled the "LABELING AND MARKETING OF NUTRITIONAL PRODUCTS INTENDED FOR USE TO DIAGNOSE, CURE, MITIGATE, TREAT, OR PREVENT DISEASES IN DOGS AND CATS". This Guide is provided for agency staff on how FDA intends to address dog and cat food products that are labeled and/or marketed as intended for use to diagnose, cure, mitigate, treat, or prevent diseases and are labeled and marketed to provide nutrients in support of meeting the animal's total daily nutrient requirements. This guide generally relates to claims made in dog or cat food products and not stand alone nutritional supplements, but should be reviewed if health claims are made.
NASC (the National Animal Supplement Council) is a group of manufacturers, including some APPA members, as well as other stakeholders, that according to its Website, provides "a forum for animal professionals, helps establish professional animal supplement research and manufacturing standards, and shares in the development and dissemination of knowledge about animal supplements." NASC presented a proposal entitled, "Compliance Plus" to AAFCO in April 2002 and has moved forward with its plans to gain ingredient definition approvals for a select group of novel ingredients. "Compliance Plus" is a program in which NASC members gain access to information for feed ingredient definition applications and work together to complete the necessary applications.
As part of the Compliance Plus program, the group has set up an adverse event reporting system, whereby its members provide information about adverse events that are linked with their products. This information is entered into a database, which is shared with the FDA. In addition, the group has developed a seal to be used on participating NASC members' products, which would show that the company complies with "Compliance Plus." To utilize the seal, companies must be NASC members, have their facilities audited by an independent auditor and demonstrated compliance with NASC's quality requirements. In this way, the group's objective is to instill confidence not only in regulators, but consumers as well.
If you manufacture a dietary supplement it may be worthwhile to join the NASC. For more information on NASC see their Web Page at www.nasc.cc or contact their President
Contact: Bill Bookout, President
National Animal Supplement Council
PO Box 2568
Valley Center, CA 92082