Recent AHPA Advocacy

This issue of the IADSA Newsflash covers Australia TGA reclassifies certain sports supplements to be regulated as medicines, South Africa down scheduled CBD to a category of complementary medicine, Korea has updated its functional food code to include ginseng as helpful to bone health and the European Commission (EC) acknowledges the potential to consider traditional use of botanicals in the efficacy assessment of health claims when traditional medicine products exist for botanicals used in foods.

In comments submitted to the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), AHPA requests the agency to amend Phase VI of its import declarations enforcement schedule by removing “other” essential oils from the list of products covered under this phase.

AHPA President Michael McGuffin sent a letter to Congressional leaders in the U.S. House and Senate to request adequate federal funding be included in a fourth COVID-19 relief package to ensure the financial viability and continued operations of the United States Postal Service (USPS).

Since the first week of March, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have been issuing warning letters alleging that marketers promoted a wide variety of products with claims to prevent, treat, mitigate, diagnose or cure COVID-19. AHPA has analyzed 135 COVID-19 related warning letters issued by either FDA or FTC or by the agencies jointly between March 6, 2020, and May 11, 2020, and made available in each agency’s coronavirus information center as of May 15, 2020.

The AHPA Foundation for Education and Research on Botanicals (AHPA ERB Foundation) is issuing a request for proposals to award grant funding to eligible applicants in order to enhance and promote knowledge and understanding of sustainable harvest of slippery elm (Ulmus rubra).  The grant supports research effects of varying rates of wild slippery elm bark harvest on tree population health and recovery across multiple harvest sites in order to inform sustainable harvest and management decisions for the species. The anticipated amount of funding available for a sustainable wild slippery elm bark harvest research project is up to $10,000 annually for up to 5 years.

To help the herbal products industry understand the evolving regulatory landscape for hemp and hemp-derived cannabidiol (CBD) products, AHPA has updated its free Hemp-CBD Status Report to include recent actions taken by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA).

The new validation and approval will allow laboratories to evaluate hemp for tetrahydrocannabinol (THC) on a dry-weight basis, as described by the U.S. Department of Agriculture’s Interim Final Rule governing the production of hemp under the 2018 Agriculture Improvement Act, known as the Farm Bill.

The Oregon Department of Justice (OR DOJ) has temporarily adopted a rule declaring it “unfair and deceptive” (and thus unlawful) to represent that any product “will prevent, treat, diagnose, mitigate, or cure coronavirus, COVID-19 or a related condition, without first having competent and reliable scientific evidence upon which to base a reasonable belief in the truth of the representation.” The temporary rule is effective for six months, until October 14, 2020.

In January 2020, Δ9-tetrahydrocannabinol (Δ9 THC) was added to the Proposition 65 list as a chemical known to cause reproductive toxicity. While Δ9 THC is present at only trace levels in hemp products, companies marketing hemp products in California should evaluate whether a warning is needed for these products. Also of concern, are other chemicals on the Proposition 65 list that may be used in the cultivation and processing of hemp and marijuana, such as the pesticides myclobutanil and carbaryl, for which some cannabis businesses have received Proposition 65 notices.

Marijuana smoke was added to the Proposition 65 list in June 2009 as a chemical known to the State of California to cause cancer. In January 2020, cannabis (marijuana) smoke and Δ9-tetrahydrocannabinol (Δ9 THC) were both added to the Proposition 65 list as chemicals known to cause reproductive toxicity. In addition to marijuana smoke and Δ9 THC, other chemicals on the Proposition 65 list that may be used in the cultivation and processing of cannabis, such as the pesticides myclobutanil and carbaryl, must be considered when cannabis businesses are determining compliance to this regulation.