The Dietary Supplement Health and Education act set the stage for the regulation of dietary supplements for human consumption. There is no equivalent regulation in the pet realm.
For products meant for pets, there is a bifurcation along the lines of intended use. Is the product meant to provide nutrition? Then it’s a food. Is it meant to deliver an active ingredient? Then it’s a ‘dosage form’ product, something akin to human supplements.
While the animal nutrition realm has no overarching legislation, it does have something the human supplement space does not: a unified trade organization structure that simplifies communication between the regulatory agencies—FDA and USDA—and the industry.
Bill Bookout is president of this unified trade organization, called the National Animal Supplement Council.
Taking DEA out of the equation
The Hemp Farming Act, passed as part of the 2018 Farm Bill, removed the DEA component associated with hemp and allowed segmentation of the plant to include the use of flowering tops and resins where the full-spectrum cannabinols are found. Hemp and CBD are unapproved for use as an animal food ingredient, said Bookout.
The US Food and Drug Administration’s position that CBD is not a permissible ingredient in a food, beverage or supplement is because it was the subject of an Investigational New Drug (IND) application (by GW Pharmaceuticals, which markets the approved CBD drug Epidiolex for the treatment of seizures associated with two rare forms of epilepsy) and was not marketed in foods prior to that application.
Light enforcement hand enlarges gray area
Marc Ullman, an attorney at counsel in the New York firm Rivkin Radler, echoed Bookout’s take on the CBD for pets question.
“It’s the same thing as for human foods and dietary supplements,” Ullman said. “It’s an ingredient that is used in a drug, so that’s an issue.
“But FDA has been very quiet in this area,” he added. “CBD in pet supplements is operating in a gray area because FDA makes pronouncements and then doesn’t take enforcement action.”
Bookout said he had consulted with then Colorado governor John Hickenlooper about how to handle cannabis derivatives in pet supplements after Colorado approved recreational marijuana use several years ago. With the new Farm Bill, that issue is slightly clearer.
NASC’s position is that hemp is allowed in dosage form products (ie. supplements) provided it doesn’t contain CBD concentrates, isolates, or synthetics, and the THC content is 0.3% or less. This does open the door to products formulated with hemp ingredients, he said, just not with CBD concentrates, isolates, or synthetics. In addition, they should be labeled as hemp, but brands can mention that they contain naturally occurring full spectrum CBD.
Bringing the law to boom town
It’s clear that pet supplement formulators weren’t waiting for the ink to dry on the Farm Bill. Bookout said he recently combed through the NASC’s adverse event reporting database, which includes information on more than 1,400 ingredients that are found in pet supplements.
“I found 78 products that contain hemp in our database,” he said. “How many are actually on the market? Probably twice that.”
Bookout said hemp products have been marketed for occasional anxiety caused by travel or fireworks, or alleviating discomfort caused by joint pain. He said he has even seen immune support claims. He said what the NASC is trying to do is to put some reasonable limits around this market while the regulatory picture for the ingredient becomes clearer.
“Any boom town environment creates chaos. Everyone gets in and they want to jump on the train. I think the industry is starting to figure this out. We have boundaries and we try to keep companies within those boundaries,” he said.