AWG Regulatory Roundup — February 25, 2025
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- Remembering Michael McGuffin
- “Healthy” Rule Effective Date Delayed
- FDA Deputy Commissioner of Human Foods Resigns Following Agency Firings
- 10-to-1 Deregulation Initiative Announced
- Trump Establishes the “Make America Healthy Again” Commission
- EO Takes Aim at FTC and Other Independent Agencies
- USDA Delays New Mushrooms and Pet Food Rule
- Hemp Happenings®
- Litigation Trends: Heavy Metal “Contamination” and Alleged Deceptive Pricing
- #TeamAWG is On the Road!
Remembering Michael McGuffin
AWG joins the many industry voices in honoring the legacy of our friend, Michael McGuffin. Michael was a pioneer not only for the herbal products industry, but also played a significant role in shaping the regulation of dietary supplements as we know it today. We honor his passion, deep knowledge, vision, and advocacy, which Jane Wilson, AHPA’s Interim Executive Director, rightly describes as “unparalleled.” Please visit AHPA’s website to learn more about Michael and his contributions.
“Healthy” Rule Effective Date Delayed
According to a Federal Register notice scheduled for publication today (Tuesday, February 25, 2025), FDA is delaying the effective date of its Final Rule defining the term “Healthy” until April 25, 2025. The delay follows President Trump’s “Regulatory Freeze Pending Review” issued on January 20, 2025, which orders agencies to consider postponing the effective dates of rules for 60 days for the purpose of reviewing any questions of fact, law, and policy the rules may raise. The initial effective date of the “Healthy” Rule was February 25, 2025. The FR notice also notes that the compliance date for the rule (February 25, 2028) remains unchanged.
FDA Deputy Commissioner of Human Foods Resigns Following Agency Firings
Jim Jones, Deputy Commissioner of FDA’s newly formed Human Foods Program, resigned on February 17, 2025, following the Trump administration’s firing of nearly 90 division staff. According to news reports over the weekend, probationary workers at agencies within the Department of Health and Human Services (HHS), including FDA, received termination letters signed by the acting head of human resources for HHS. In total, approximately 700 FDA staff were fired. On February 20, 2025, Bloomberg News reported that attorney Kyle Diamantas has been tapped to replace Jones. (Registration required to access link.)
10-to-1 Deregulation Initiative Announced
On January 31, 2025, President Trump issued a Fact Sheet previewing the launch of a “massive 10-to-1 deregulation initiative” through an Executive Order. The Order, published in the Federal Register on February 6, is entitled “Unleashing Prosperity Through Deregulation” and requires that whenever an agency promulgates a new rule, regulation, or guidance, it must identify at least 10 existing rules, regulations, or guidance documents to be repealed, among other requirements.
In addition to guidance documents, the term “regulation” or “rule” includes memoranda, administrative orders, policy statements, and interagency agreements. The EO excludes certain regulations from the 10-to-1 initiative, including those issued with respect to a military, national security, homeland security, foreign affairs, or immigration-related function of the U.S. and those related to agency organization, management, or personnel.
Trump Establishes the “Make America Healthy Again” Commission
On February 13, 2025, President Trump signed an Executive Order creating the “Make America Healthy Again Commission,” which seeks to “re-direct our national focus, in the public and private sectors, toward understanding and drastically lowering chronic disease rates and ending childhood chronic disease.” The commission would focus on policies aimed at reversing chronic disease through transparent research; ensuring U.S. food is the “healthiest, most abundant, and most affordable in the world;” prioritizing research to investigate the root causes of disease; and ensuring treatment options and insurance coverage to support healthy lifestyle changes and disease prevention.
Within 100 days of the order, the commission – composed of various agency heads – must submit to the President a “Make Our Children Healthy Again Assessment” to evaluate health risks from food ingredients, chemicals, prescription drugs, nutrition, and lifestyle factors. Within 180 days, the commission must submit a “Make our Children Healthy Again Strategy” based on the assessment findings.
EO Takes Aim at FTC and Other Independent Agencies
Another Executive Order entitled “Ensuring Accountability for All Agencies” and signed by the President on February 18, 2025, requires independent regulatory agencies, including the FTC, to submit for review all proposed and final significant regulatory actions to the Office of Information and Regulatory Affairs within the Executive Office of the President prior to publication in the Federal Register. The EO states that “[t]hese regulatory agencies currently exercise substantial executive authority without sufficient accountability to the President, and through him, to the American people” and “have been permitted to promulgate significant regulations without review by the President.”
USDA Delays New Mushrooms and Pet Food Rule
The USDA Agricultural Marketing Service has delayed the effective and compliance date of the National Organic Program’s Market Development for Mushrooms and Pet Food Final Rule, which was published and initially effective on December 23, 2024. The new effective date is March 21, 2025, and the delay was published in accordance with the President’s January 20, 2025 “Regulatory Freeze Pending Review” memo. With the change in effective date, all organic mushroom and pet food operations must comply with the rule by March 22, 2027.
Hemp Happenings®
As expected, states are plowing forward with a wave of proposals aimed at increasing restrictions on hemp products. Here are a few we’re watching closely over the coming months:
- Arizona SB 1702 would establish a framework for the regulation of hemp-derived products along with age restrictions, serving limits, and testing, labeling, and registration requirements.
- Missouri HB 393 and HB 696 would impose various requirements for the sale of hemp products, including testing, labeling, licensing, and marketing requirements with penalties for non-compliance, and SB 984 goes a different direction by classifying all “intoxicating cannabinoids” (defined as those with an “intoxicating effect”) as “marijuana.”
- New Mexico HB 346 would prohibit “semi-synthetic” and “synthetic cannabinoids” in hemp products and directs the NM Environment Department to adopt rules establishing labeling, registration, and related requirements for hemp products.
- Texas SB 3 would allow only CBD and CBG in consumable hemp products – prohibiting all THC and other cannabinoids in products – and requires product registration, as well as marketing and packaging restrictions.
Of note, California’s ban on ingestible hemp products with detectable THC is set to expire on March 25, 2025. It remains to be seen whether the ban will be extended, but we’ve heard rumors that California cannabis companies are pushing for an extension.
Litigation Trends: Heavy Metal “Contamination” and Alleged Deceptive Pricing
Complaints targeting products marketed as safe or healthy, but that fail to disclose the presence of heavy metals like lead and arsenic, continue to pile up. Testing conducted by consumer groups such as Lead Safe Mama is often cited in these complaints and serves as a reminder to be proactive and stay informed when it comes to product testing and label claims.
Another trend across a range of consumer product categories focuses on alleged deceptive pricing practices. Plaintiffs’ attorneys are zeroing in on “surprise fees” added during the check-out process, as well as artificially inflated “regular prices” with corresponding “sale prices” that give the false impression of a bargain. The takeaway? When something is always on sale, it’s never on sale.
#TeamAWG is On the Road!
Headed to Natural Product Expo West? If so, drop a line to Ivan, Rakesh, or Bob, who will be there all week and would love to connect.
Thanks for reading!
Rend Al-Mondhiry, Editor
