Over at our Life Sciences Decoded blog, we have discussed the state of limbo in which animal dietary supplements exist from a regulatory perspective. In the case of human products, foods, dietary supplements and drugs occupy three different regulatory areas, each with its own requirements, manufacturing standards and premarket application needs. Each also has unique regulatory systems. Food has HARPC and FSMA, drugs have generic versions and extraordinarily complex and expensive premarket approval requirements, and dietary supplements have unique labeling requirements. This is largely because of the Dietary Supplement Health and Education Act of 1994 (DSHEA) which delineated supplements from regular food products and from drugs designed to cure diseases.
The same delineation does not apply to products made for animal consumption. In 1996, and echoed in 2002, the FDA stated that DSHEA does not apply to products for animals. As a result, the FDA treats all products for animals as one of three main products:
- Animal feed is defined as an article for food or animal consumption.
- A feed additive is typically any substance which is expected to become a component of animal food either as an ingredient or by top dressing a feed or placement in the animal’s water.
- A drug is defined as an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. This includes Medicated Type A articles and the products derived from them, called medicated feeds.
A look at the animal supplement market reveals products similar to those products found in the human dietary supplement markets – products intended to affect or support a structure or function of the body. These products do not meet the definitions of a feed, feed additive or drug. Without the application of DSHEA, the result has been, to date, a virtually unregulated market.
Cannabis and animal products
The question, therefore, is what should the cannabis industry do when considering the production of cannabis-based supplement products for animals? What FDA regulation should these industry members expect? Last year, Life Sciences Decoded predicted that the majority of these animal supplement products would likely be considered foods and fall under the control of the FDA’s new rules under the Food Safety Modernization Act (FSMA). This means they will be subject to significant oversight and regulatory requirements. Life Sciences Decoded covered the basics of these regulatory regimes generally but more specifically as they apply to animal products and include:
- Hazard Analysis and Risk-based Preventive Controls (HARPC) for animal foods
- The Sanitary Transport of Human and Animal Food
The question then becomes, will cannabis products meant for animals be treated as a food or drug by the FDA? The first and foremost place to look is, of course, the FDA. However, despite cannabis’ continued Schedule I classification in the case of human uses, the FDA has been relatively silent on the use of cannabis in animal products. The closest the FDA has come to addressing the issue is a series of 2015 warning letters to members of the cannabis industry. Of those letters, one was directed toward Canna-Pet, LLC for four of its products aimed at dogs and cats. In this letter, the FDA determined that Canna-Pet’s products were drugs under 21 U.S.C. § 321 (g)(1)(B) which defines a drug as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals."
In finding that the products were drugs, the FDA looked to Canna-Pet’s own marketing claims related to these products, which included:
- Antitumor, Antiepileptic, Anticancer, Anti-inflammatory, Bone stimulant, Analgesic, Anti-depressant, Antibacterial, Antipsoriatic, Antidiabetic, . . . Anti-nausea, Anti-anxiety, . . . Antipsychotic, . . . Immunosuppressive.
- We Recommend Canna-Pet™ as a daily food additive for all pets, but especially for those with arthritis, allergies, anxiety or behavior issues, compromised immune systems, diabetes, digestive issues, nausea, chronic pain, cancer, seizures, and those receiving palliative care.
The important distinction for the cannabis industry is that the FDA labeled Canna-Pet products as drugs not because they contained cannabis or cannabis extracts, but because the Canna-Pet products were, “intended to mitigate, treat, or prevent disease in animals, it is a drug.” Under 21 U.S.C. §§ 360b, 360ccc and 360ccc-1, new animal drug products must be approved pursuant to a new animal drug application, the subject of a conditionally approved new animal drug application, or an index listing, respectively. Without these approvals, the FDA will find products for animals meeting the definition of a drug to be unsafe and adulterated under the FDCA. This means the FDA has the ability to issue warning letters, obtain injunctions against the sale of the products, and seize the products.
Impact of the Cole Memorandum and the Rohrabacher-Farr medical marijuana amendment
Currently, there are limitations as to how the federal government can pursue enforcement actions against members of the cannabis industry. Two major federal government actions are responsible for these limitations. First, the document known as the “Cole Memorandum,” previously discussed here on Tracking Cannabis, is a statement by the Department of Justice (DOJ) that it will not pursue charges against individuals involved in, or participating in, the cannabis industries in states where there are rigorous and enforced regulatory systems to control cannabis products. In 2014, Congress passed the Rohrabacher-Farr medical marijuana amendment that stated:
None of the funds made available in this Act to the Department of Justice may be used, with respect to [states with cannabis legalization statutes] to prevent such States from implementing their own State laws that authorize the use, distribution, possession, or cultivation of medical marijuana.
Many in the industry see this as a free pass for cannabis businesses to operate without federal interference. Nothing could be further from the truth. First, the Rohrabacher-Farr amendment and Cole Memorandum apply only to medical cannabis programs, and do not apply to recreational cannabis use. Second, they only apply to the Department of Justice, and therefore its enforcement actions involving cannabis activities. This is a narrow set of activities the federal government cannot partake in, and generally does not apply to the FDA and its administrative or civil activities. In addition, to the foregoing, there is great concern over how the new administration will continue to view cannabis, particularly in light of the nomination of Jeff Sessions for U.S. Attorney General.
The prime example of this are the warning letters the FDA sent to members of the industry in 2015 and 2016. These letters represent meaningful enforcement actions against the cannabis industry, and these letters were spawned by a significant number of activities and situations. For example, one of the products that led to the Canna-Pets letters described above, despite advertising itself as CBD product, contained no cannabis or cannabis extracts at all. In addition, while no such actions have occurred yet, there is little reason why other federal agencies (such as the FTC regulating misleading advertising) could not regulate the cannabis industry.
What does this mean for members of the cannabis industry looking to produce products for animals? First, understanding that marketing terminology matters is key to positioning products not as drugs, but rather as foods or feeds not subject to the premarket approval process and clinical trial requirements for animal drugs.
Regulatory counsel can review your marketing and ensure that your products avoid making drug-like claims (“treats epilepsy” or “anti-tumor”). Second, avoiding classification as a drug is the first step to avoiding the FDA’s enforcement activities. The second is ensuring that your internal processes meet all applicable regulatory requirements. This may include having a compliant food safety plan; an understanding of your suppliers not just of active ingredients but other ingredients and even packaging as well; and managing the safe and sanitary transportation of ingredients and finished products.
Thompson Coburn has a staff of regulatory counsel experienced in FDA enforcement, FDA regulatory requirements and other issues related to the manufacture of animal products, including both foods and drugs. Our cannabis practice works very closely on these regulations with our cannabis clients. If you have any questions about any of the posts you see here on Tracking Cannabis, please feel free to reach out to any of our team members.
Diane Romza-Kutz is a partner whose practice focuses on the life sciences industry, including the representation of cannabis businesses and investors.