In letters sent this morning to Sen. Wyden and FDA Acting Commissioner Janet Woodcock, CBA argues that a federal regulatory framework for CBD products “is needed now to protect consumers; ensure product safety and transparency; establish guardrails for legal product innovation and distribution in interstate commerce; and provide the clarity needed for manufacturers of these products.”
It underscores the urgency for action by noting in the letter sent to Woodcock that “the current FDA stance on CBD products is not working.”
It explains in the letter that while “FDA has been steadfast in its position over the past several years that CBD-containing dietary supplements and foods cannot be marketed under the exclusionary clauses and that the use of these products presents potentially serious safety concerns,” the agency’s “inaction is resulting in a marketplace full of CBD-containing products produced in establishments that escape FDA regulations.”
While CBA acknowledges not all CBD products have ‘escaped’ FDA oversight, it notes only a relative handful of the most egregious violators have triggered agency action. Since 2015, FDA and the Federal Trade Commission has limited action against products with CBD to 81 warning letters sent to only the violators that make claims their products can treat or cure serious diseases, CBA notes.
Lack of action also has led to widespread consumer confusion, CBA argues, noting recent results from a survey it conducted that reveals 67% of Americans incorrectly believe the ingredient is federally regulated, and 28% who have tried CBD despite rating their knowledge of the ingredient on average at 3.3 on a scale of one to ten.
“This knowledge gap, in concert with the lack of federal regulation, should create urgency for FDA to engage,” CBA argues in the letter.
Consumer confusion is further compounded by state legislation, including 135 proposals in 38 states, of varying degrees of rigor for oversight of CBA, which CBA argues “have created a confusing, conflicting regulatory patchwork that fails to establish uniform requirements for the safe formulation, production, labeling and marketing of these products.”
Against this backdrop, CBA argues that “until the federal government establishes clear, uniform standards for testing, safety and ingredient levels, the CBD market will continue to grow without appropriate federal oversight, potentially placing American consumers at risk.”
To limit the danger and create a level field on which established and law-abiding food, beverage and supplement providers can play, CBA asks FDA in the letter to transparently and scientifically evaluate the safety of CBD and specific products with it as an ingredient, update stakeholders about the development of a regulatory framework for CBD products, work with Congress to develop “workable solutions” for CBD products, more aggressively enforce against CBD products making misleading claims and create a “plan of action for transitioning currently marketed CBD-containing products to the new regulatory framework.”
CBA supports the Hemp Access and Consumer Safety Act
CBA echoes these sentiments and requests in a second letter sent this morning to Sen. Wyden, in which it also pledged its support for his Hemp Access and Consumer Safety Act.
The Act was introduced in May by Wyden and Sens. Rand Paul, R-Ky, and Jeff Merkley, D-Ore., and would allow the use of CBD and other hemp derivatives in dietary supplements by carving out an exception for the ingredients in the so-called ‘exclusion clause’ of the Food Drug and Cosmetics Act, which prohibits the use as a dietary ingredient any substance previously investigated as a drug – as in the case of CBD.
Arguing in the letter to Wyden that “American consumers need and deserve smart, consistent regulations to govern the CBD market,” the trade group praised the proposed legislation as “a big step in the right direction.”
Ultimately, CBA says in a separate statement that its “call for swift action is not about being for or against CBD. It is about being pro-consumer.”
It adds: “The desire for safe, innovative products will drive market growth, but continuing to grapple with misinformation, misconceptions and misunderstandings will cripple CBD’s potential before it can prove its value.”