NPA’s Fabricant on CBD, NDI-related import alerts, and banned stimulants Efforts to move the needle on hemp-CBD at the Federal level are slow, and upcoming exits of key personnel at FDA are unlikely to affect progress much, says NPA’s Dr Daniel Fabricant. “In some ways I think FDA likes the status quo,” he tells NutraIngredients-USA.
The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act was re-introduced in the US House of Representatives in February with the aim of making hemp and hemp-derived CBD a dietary ingredient in dietary supplements.
Designated as HR 841, the bill directs the FDA to use its authority and resources to set a clear regulatory framework for hemp and hemp derived CBD and assure consumer protection. It has received widespread support from dietary supplement trade associations and hemp stakeholders, with NPA being the most notable dissenter for the bill because it fails to set a safe level of daily
FDA seizes Chinese imports over NDI status
The alert, which was issued Friday,
covers products from two Chinese companies. In both cases the Chinese firms listed the products as higenamine, a stimulant. The products were seized under FDA’s Detention Without Physical Examination authority. The firms can petition to have the products released if they meet certain stipulations from the Agency.
Prominent industry critic Dr Pieter Cohen, MD, of Harvard Medical School, called higenamine into question
Clinical Toxicology. John Travis, PhD, of NSF International, and others, including researchers associated with the Dutch National Institute for Health and the Environment were listed as coauthors. The report analyzed the contents of 24 supplements that were labeled to contain higenamine or one of its synonyms, such as norcoclaurine or demethylcoclaurine.
NPA, others support CA CBD bill while still advocating for federal solution Yesterday the Natural Products Association testified in favor of a California bill to regulate the CBD trade in that state. NPA and others, however, have reiterated a call for federal legislation that would forestall the growing patchwork quilt of state regulations.
The bill, designated as SB-235, was introduced in the California Senate on Jan. 19 by Sen. Ben Allen. The bill is the counterpart of an Assembly bill (AB 45) that was introduced by Assemblywoman Cecilia Aguiar-Curry.
In absence of federal rules regarding the hemp/CBD trade, the bill would:
Industry group clarifies hemp definition in wake of Delta-8 THC confusion Recent news reports about the marketing of products featuring Delta-8 THC as a prominent constituent have muddied the waters enough that the US Hemp Roundtable felt it necessary to clarify again what should and shouldn’t be called a hemp product.
Recent headlines in both
The New York Times and
Rolling Stone magazine have created some confusion, said Jonathan Miller, an attorney in the firm Frost Brown Todd who is also general counsel for the roundtable, a hemp industry group.
Recent news reports obfuscate the issue
The Times headline read;
To summarize, the key aspects required by Amazon are:
1. A Certificate of Analysis (CoA) from an ISO/IEC 17025 accredited laboratory (in-house or third party) for each dietary supplement you are applying to list OR product enrollment in an Independent Quality Certification Program, such as NSF International Sport, BSCG, Informed-Choice/Informed-Sport, or active participants of USP Dietary Supplement Verification Program
2. A Letter of Guarantee from the brand owner of the product that guarantees compliance with current Good Manufacturing Practices (21 CFR Part 111); assurances that the products only contains lawful and safe ingredients (as defined in section 402 (f) of the FD&C Act); and that labels are accurate.