Colorado’s new cannabis rules suggest a wave of extensive government regulations

While the Food and Drug Administration (FDA) remains reluctant to find a legal way to manufacture, sell, and distribute hemp products, government regulators keep pace with the demands of this evolving market and adopt increasingly differentiated and sophisticated regulations for them these products.

Several states, including Oregon and Colorado, first introduced hemp regulations in 2015 after the 2014 Farm Bill passed. Although these regulations were quite extensive at the time, they quickly became too broad to adequately regulate the wide range of product categories that eventually came to market. To address this problem, these states have had to change their regulations frequently to keep up with the industry.

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Earlier this year, the Colorado Department of Public Health and Environment (CDPHE) approved a new set of rules that recently went into effect (the labeling requirements and some of the testing requirements went into effect on July 1 to form one). the most comprehensive regulatory framework in the country.

Many of the newly enacted CDPHE rules address issues that have become hugely important to the industry but still need to be addressed by state regulators – and the FDA. Some of these problems are described below.

nomenclature

The CDPHE regulations allow the sale of hemp-derived foods, dietary supplements and cosmetics as long as these products contain ingredients from an “Approved Source”. The term “Approved Source” includes CDPHE-registered manufacturers and wholesalers, but also non-state products that come from states and countries that regulate these products to ensure their safety for human consumption. By adopting a broad definition of the term “approved source”, the CDPHE recognized that many hemp products sold in the state originate from other jurisdictions and that these products, albeit in part, need to be regulated.

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The regulations also define terms such as “broad spectrum”, “cannabinoids”, “full spectrum”, “industrial hemp extract” and “unfinished industrial hemp products”. are now available in the US and adapt the regulations to the specifics and subtleties of each product category.

Processing and manufacturing

State manufacturers and processors must be registered with the CDPHE and meet specific manufacturing requirements, such as: B. the creation of a very detailed, written recall plan in accordance with federal law.

Testing

In addition to testing the products for compliant THC and total THC values, the CDPHE requires that from the 1st on they are safe for human consumption.

labeling

The new regulations stipulate that product labels comply with the general labeling requirements of the Federal Food, Drugs and Cosmetics Act, including the labeling of allergens for food and dietary supplements and, if necessary, warning notices to avoid a health hazard that may be associated with a cosmetic product Be associated. After adopting these new rules, the CDPHE also published very detailed labeling guidelines for each product category it regulates: food, dietary supplements and cosmetics.

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Other notable labeling requirements include: (1) identification of each isolated cannabinoid as an ingredient and its concentration in milligrams; (2) Listing of the THC content per serving and the total THC per pack of the finished product; and (3) incorporating a code or numbering system that identifies the date and place of manufacture and packaging so that products can be easily traced in the event of a recall.

transport

The CDPHE also prescribes transportation requirements, which dictate that unfinished and finished hemp products are packaged and transported in such a way that they are protected from adulteration, allergen cross-contact, environmental pollution and other hazards.

If you follow this blog, you may have noticed that the CDPHE regulations mirror many of the proposed regulations published by the New York Department of Health in October 2020, which we described as “the most comprehensive” regulations at the time. You can read more on this topic here and here.

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These newly enacted ordinances and proposed ordinances suggest that state regulators anticipate upcoming federal regulations and proactively adapt their requirements to those already imposed by federal laws.

In addition, by introducing high quality testing standards and providing greater transparency and accuracy in the labeling and marketing of these products, government regulators are helping to legitimize the industry, build consumer trust and expand this promising market. Now we can only hope that the leadership of these states will inspire the FDA to finally perform its administrative functions, allow the industry to follow its course and succeed.

Nathalie Bougenies is an attorney with Harris Bricken. This article was originally published on the Canna Law Blog and is republished with permission.