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Recent AHPA Advocacy

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FDA and FTC highlight attention to intravenous therapies and social media in COVID-19 warning letters

Excerpt from the June 2020 AHPA Report

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.

Request for proposals: Slippery elm sustainable wild harvest study

Request for proposals: Slippery elm sustainable wild harvest study

Deadline extended to July 10, 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.

AHPA Hemp-CBD Status Report

Updated in April 2020 to cover recent FDA and USDA actions

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).

AOAC Scientists Approve Official Method of Analysis for Cannabinoids in Hemp

AHPA Chief Science Officer Dr. Holly Johnson chairs CASP working group involved creating requirements for testing standard

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.

Oregon adopts temporary rule prohibiting unsubstantiated claims that goods prevent, treat, diagnose, or mitigate COVID-19 related conditions

AHPA has been working with other trade organizations to seek withdrawal of a much-broader proposed rule that the OR DOJ published for comment late last year and in amended form in March 2020.

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.

Guidance on California Proposition 65 and Hemp Products

Revised April 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.

Guidance on California Proposition 65 and Cannabis Products

Revised April 2020

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.

AHPA and CRN express concern about Proposed Rule in Oregon that would create private right of action for opportunistic plaintiffs’ lawyers

AHPA and CRN urge that Oregon Proposed Rule is unnecessary and should be withdrawn

AHPA and the Council for Responsible Nutrition (CRN) filed joint comments last week to reiterate significant concerns to the Oregon Department of Justice (OR DOJ) about a Proposed Rule that would create a private right of action for opportunistic plaintiffs' lawyers motivated by the potential for recovery rather than the public interest.

AHPA submits supply chain issues to USDA and continues to collect industry data

Report your supply chain issues to AHPA using this brief survey

AHPA has reported to the U.S. Department of Agriculture (USDA) a host of supply chain issues submitted by members and others in the herbal community. The information submitted to USDA reports on shortages or delivery disruptions of a variety of ingredients, supplies, and services. AHPA also continues to collect supply chain data to inform the industry, regulators and lawmakers.

Supplement Industry Associations Applaud FDA Actions to Protect Consumers from Fraudulent Products Related to Coronavirus Disease (COVID-19)

Washington D.C., April 6, 2020

The U.S. dietary supplement industry commends the Food and Drug Administration (FDA) for taking action to protect consumers by calling out marketers who make illegal and unsubstantiated drug claims related to COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2. In February, the industry issued strong warning to companies and consumers to avoid marketing or using dietary supplements that are presented as treating, curing or preventing COVID-19.

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