Although the U.S. Food and Drug Administration ( Food and Drug Administration) Continue to delay the development of legal pathways for the manufacture, sale, and distribution of cannabis-derived products, and state regulators are keeping up with the demands of this evolving market and adopting increasingly detailed and complex regulations for these products.

Several states, including Oregon with ColoradoAfter the 2014 Farm Bill was promulgated, hemp regulations were enacted for the first time in 2015. Although fairly comprehensive at the time, these regulations quickly became too broad to adequately supervise the wide range of product categories that eventually appeared on the market. In order to solve this problem, these states have to constantly modify their regulations to keep up with the pace of industry development.

Earlier this year, the Colorado Department of Public Health and Environment ( CDPHE) Adopted New rules It came into force recently (labeling requirements and some testing requirements came into effect on July 1st) and now constitutes one of the most comprehensive regulatory frameworks in the country.

Many of the new rules passed by CDPHE have resolved issues that are important to the industry but have not yet been resolved by state regulatory agencies and the FDA. Some of these issues are summarized below.

Nomenclature

The CDPHE regulations authorize the sale of hemp-derived foods, dietary supplements, and cosmetics, provided that these products contain ingredients from “approved sources.” The term “approved source” includes CDPHE-registered manufacturers and wholesalers, as well as out-of-state products from states and countries that regulate these products to ensure that they are safe for human consumption. By adopting a broad definition of the term “approved source”, CDPHE recognizes that many cannabis-derived products sold in the state come from other jurisdictions and that these products need to be regulated, even if partially regulated.

The regulations also define terms such as “broad spectrum”, “cannabinoids”, “full spectrum”, “industrial hemp extract” and “unfinished industrial hemp products”, indicating the need to clearly identify and distinguish between various hemp-infused products. It can be used in the United States, and regulations can be customized to suit the particularity and complexity of each product category.

Manufacturing

State manufacturers and processors must be registered with CDPHE and must meet specific manufacturing requirements, such as a very detailed written recall plan under federal law.

test

In addition to the THC and total THC compliance levels of the tested products, CDPHE also requires that from August 1st, more than 100% of the cannabis injection products produced in the state should be tested. Insecticide, Microorganisms, heavy metals and residual solvents to ensure that they are safe for human consumption.

label

The new regulations require product labels to comply with the general labeling requirements of the Federal Food, Drug, and Cosmetic Act, including identifying allergens in food and dietary supplements, and providing warning statements when necessary to prevent health hazards that may be related to cosmetics. After adopting these new rules, CDPHE has also issued very detailed labeling guidelines for each product category it regulates: food, Dietary Supplements, with cosmetic.

Other notable labeling requirements include: (1) Identify each isolated cannabinoid as an ingredient and its concentration (in milligrams); (2) List the THC content of each serving and the total THC of each finished package (3) Include a code or numbering system to identify the date and location of manufacturing and packaging so that the product can be easily tracked in the event of a recall.

transport

CDPHE also put forward transportation requirements, compulsory packaging and transportation of unfinished and completed cannabis products to prevent adulteration, cross-contact with allergens, environmental pollution and any other hazards.

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If you follow this blog, you may have noticed that CDPHE’s regulations reflect many of the proposed regulations issued by the New York Department of Health in October 2020, when we described it as the “most comprehensive” set of regulations date.You can read more about this issue Here with Here.

These newly passed regulations and proposed regulations indicate that state regulators are anticipating upcoming federal regulations and are proactively aligning their requirements with those already implemented by federal law.

In addition, by adopting high-quality testing standards and requiring greater transparency and accuracy in the labeling and marketing of these products, national regulators are helping to legalize the industry, build consumer confidence and expand this promising market. What we can hope now is that the leaders of these states will inspire the FDA to finally perform its administrative functions so that the industry can get on track and succeed.