US FDA will regulate hemp NPD, despite legal status, warns AHPA as it launches Guidance Policy
29 Mar 2019 --- In light of hemp’s recent declassification as a schedule 1 narcotic, which widened the potential for its use in the food, beverage and supplement industry, the American Herbal Products Association (AHPA) has adopted a new Guidance Policy. The policy is for dietary supplement and food products that contain hemp and hemp-derived cannabidiol (CBD) to help ensure the industry complies with existing regulations.
In a significant development for the cannabis market last year, the US Food and Drug Administration (FDA) approved a CBD product as a drug for epilepsy – Epilodex – and President Trump signed the Agriculture Improvement Act of 2018 (the Farm Bill) which legitimized low THC hemp (<0.3 percent Δ9-THC). Although this rules out the chances of anyone getting high from hemp, it does mean that the cannabis-variety is removed from the Controlled Substances Act (CSA).
The AHPA Guidance Policy was developed to encourage industry to be mindful of the federal regulations that apply to these product categories, especially as the regulation change continues to increase both consumer and industry interest in cannabis products. The guidance is also in light of the FDA’s ongoing review of the status of hemp-derived CBD and potential pathways for lawful addition of CBD to food and dietary supplements.
“The FDA’s current position on the lawful status of CBD shouldn’t be misinterpreted to mean that FDA does not regulate supplement or food products that contain hemp or CBD,” says AHPA President Michael McGuffin. “Hemp and CBD companies should maintain compliance with established regulations for dietary supplement and food products to ensure quality and safety.”
Indeed, coinciding with the signing of the Farm Bill in December, FDA Commissioner, Dr. Gottlieb, issued a “cautionary” reminder. In the statement, Gottlieb enforces the changes made to the legal status of hemp in the Farm Bill, as well as reiterating the importance of what the law didn’t change. “Congress explicitly preserved the agency’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,” he notes.
“We’re aware of the growing public interest in cannabis and cannabis-derived products, including CBD. This increasing public interest in these products makes it even more important with the passage of this law for the FDA to clarify its regulatory authority over these products,” says Dr. Gottlieb.
The AHPA policy recommends that any manufacturer, labeler, packer, holder or marketer of dietary supplements or foods that contain hemp or CBD comply with the following federal regulations:
- food facility registration;
- current good manufacturing and good agricultural practice regulations;
- labeling requirements, including nutrition labeling, allergen disclosure, listing of required contact information, absence of drug claims, etc.;
- new dietary ingredient and food additive provisions, where applicable;
- applicable obligations for timely submission to FDA of any received serious adverse event reports associated with their products.
The AHPA develops guidance policies to promote responsible commerce in herbal supplements by addressing a variety of labeling and manufacturing issues. These policies reflect the consensus of AHPA members and Board of Trustees and the association encourages its members and non-member companies to adopt these policies to establish consistent and informed trade practices.
NPD and technology in the hemp and hemp-derived CBD space is growing. The Hemp Business Journal estimates that the hemp CBD market totaled US$190 million in 2018 – an astounding rate of growth for a category that didn’t officially exist five years ago.
Innova Market Insights has reported a 34 percent average annual growth in the number of new food & beverage launches with hemp ingredients (Global, 2013-2017), with US introductions enjoying an average annual growth of 21 percent over this period.
Earlier this year, Arcadia Speciality Genomics, a strategic business unit of agricultural food ingredient company Arcadia Biosciences, announced that it sought to bring improved plant quality to cannabis crops by applying its proprietary approach to plant breeding and gene editing. The news attracted “significant inbound interest from the cannabis industry,” Matt Plavan, President of Arcadia Speciality Genomics, tells NutritionInsight.
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