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CBD Enforcement Policy Draft Guidance Submitted to White House by FDA

The U.S. Federal Food and Drug (FDA) officials have submitted its Cannabidiol (CBD) Enforcement Policy Draft Guidance for Industry policy document for approval by the White House. This means that industry guidance on CBD is nearing, which can only mean good things for the industry.

If the White House Office of Management and Budget approves the policy, a public release of enforcement policy could arrive within a matter of weeks. The White House Office of Management and Budget is required to sign off on any new regulations from any federal agency.

It is believed that the approval of the policy could finally mean some clarity in the CBD industry. Attorney Jonathan Havens, a Washington DC-based partner with Saul Ewing Arnstein & Leh, wrote a LinkedIn post on Thursday. In the post, Havens noted that the enforcement policy could be claims-focused. This means that it could work to control the illegal, unsubstantiated claims that companies have been making about their CBD products. Havens does not, however, believe that this will adjust the FDA’s policy that CBD ingestibles are not permitted.

Havens provided further clarification to Hemp Industry Daily

It could be claims-based, serving size-based, (which is) less likely, product standards-based, some combination of the three, or something else

On the standards front, it’s possible FDA could start to hold ingestible CBD marketers to the agency’s dietary-supplement regulations, for example, good manufacturing practice requirements.

Such standard [sic] are what the supplement-industry trade associations have been pushing for.

It would raise the bar for the industry, push out unsavory firms who are producing unsafe products and allow marketers to say that they comply with FDA requirements, which would hopefully smooth out the true patchwork of state requirements, among other benefits.

This submission to the White House is arriving only a few days after the FDA submitted a guidance draft for clinical research relating to developing cannabis and cannabis-derived drug products.