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Новости/Аналитика

US Cannabinoid Raw Materials

09.04.2020

The use of various ingredients of technical hemp in the cosmetics industry was approved by US government officials back in 2003, but only the introduction of amendments to the Law on Farming in 2018 made it possible to use all components of technical hemp for the production of cosmetic products .

History 

In 2003, officials from the Drug Enforcement Administration (DEA), the US government responsible for enforcing the Controlled Substances Act , announced that they would allow the use of all components of technical hemp in cosmetics and personal care products. In substantiating this position, government officials of the Department noted that low concentrations of controlled tetrahydrocannabinol (THC) in malonarcotic hemp do not pose a risk to the external integument of the human body , including if they are part of cosmetic preparations. In addition, DEA officials officially announced that they will allow the use of cannabis-free cannabis in other groups of products , for example, in the fabrics from which clothes and shoes are made . It should be noted that these statements about the possibility of using leaves and inflorescences of technical hemp in the cosmetic field of the officials of the Department were voiced when no one had already started discussing the possibility of legal cultivation , processing , and also sales of products  from  industrial hemp crops at the level of federal regulatory legal acts US .

Only in December 2018, amendments to the Law on Farms were adopted , providing not only the possibility of cultivating industrial crops of technical hemp at the federal level, but also regulating the use of drug-free cannabinoids (primarily cannabidiol) for industrial purposes . Especially the federal law of the USA does not allow the use of only the provisions of the law "On farms" for the use of leaves and inflorescences of industrial hemp in industrial uses . At the moment, at the level of regulatory legal acts, no changes have been made to the US Law on Food , Drugs and Cosmetics (Federal Food , Drug , and Cosmetic Act). Based on the above, it turns out that despite the fact that industrial hemp and beznarkoticheskie cannabinoids vegetable legalized throughout the territory of the United States , the use of raw materials in the products controlled by the Office of for the control products and medicines ( Food Food and Drug Administration, the FDA) is administered by of the aforementioned Office and, accordingly, the production and sale of this kind of product groups will be regulated by regulations prepared by the Food and Drug Administration. 

Permitted Uses

Since psychoactive hemp is still on the list of controlled substances, the “green mass” of psychoactive hemp or any substances derived from such plants cannot be used in goods distributed at the federal level, unless specifically approved by the FDA and DEA . In turn, as stipulated in the Farming Act , industrial hemp can be legally grown and also used nationally in the United States , including its use in FDA-regulated products , provided that the hemp raw material meets the definition of industrial hemp in the United States (contains not more than 0.3% tetrahydrocannabinol - THC). 

Application of industrial hemp in a raw material for the production of drugs or the use of any substances derived from bezgashishnoy hemp for the manufacture of pharmacological agents should be regulated by regulations of the FDA. Those. drugs of this kind must undergo the appropriate procedure prescribed by the FDA, which, for example, the pharmacological preparation “Epidiolex” has passed. This algorithm of actions involves the organization of appropriate laboratory tests , as well as a host of clinical trials . 

As a result of the amendments to the Farming Act , technical hemp , as well as drug-free cannabinoids of plant origin, were actually legalized in the United States , but the FDA took the position that the above hemp raw materials cannot be used for the production of food additives . FDA officials have approved the use of substances derived from industrial hemp in three by-laws on food additives , which clearly identify hemp ingredients that may be present in foods . In the above documents, in particular, it is noted that only trace amounts of THC or cannabidiol (CBD) are permissible in food products . It should be noted that in certain administrative and territorial units of the United States there is its own legislation regulating the possibility of using cannabinoids in a wide range of products , including drugs , food , drinks or dietary supplements .

As mentioned earlier, the use of various ingredients of technical hemp in the cosmetics industry was approved by US government officials back in 2003, but only the introduction of amendments to the Law on Farming in 2018 made it possible to use all components of technical hemp for the production of cosmetic products .

Under current US law , the seller is responsible for ensuring both the safety of the ingredients and the formula of the cosmetic product that he is selling . In other cases, the cosmetic product is marked with a warning “ product safety has not been established.”

A reasonable testing program for hemp raw materials used in cosmetics contains requirements for the levels of THC and CBD , the amount of terpenes , heavy metals, solvent, microbes, mycotoxins and pesticides. In addition to the traditional certificate of analysis of hemp raw materials , if necessary, the ingredients used for the production of cosmetic products should be provided for independent examination . 

The hemp raw materials used for the manufacture of cosmetic products should not have any complaints from the regulatory authorities . This also applies to labeling and description of cosmetic products . In particular, the information on the hemp cosmetics label should not contain information that the drug sold can prevent, cure or mitigate various skin diseases. In addition, cosmetic products , manufactured for use in body care and hair should not adversely affect the changes in the structure or functions of the humane body.

Due to the high degree of public interest in cannabidiol , marketers everywhere draw buyers' attention to the presence of CBD in the formula of cosmetic products . Until recently, the presence of cannabidiol in the composition of cannabinoid oil was noted, but now the trend has partially changed, and marketing departments use the CBD designation emphasizing its plant origin and the presence of this drug-free cannabinoid  in the formula of cosmetic preparations precisely as its exclusive element with great therapeutic properties . Accordingly, marketers differently beat the benefits of the healing properties of natural cannabidiol in the formula of a cosmetic product sold .

Since drug-free cannabinoids of plant origin in the near future will be universally used as basic cosmetic components , there are practical questions that American cosmetic companies should consider when searching for raw materials . First of all, this concerns the level of THC - the ingredients obtained from plant materials should not contain tetrahydrocannabinol levels exceeding 0.3%. In addition, given the fact that natural cannabidiol is rather unstable, it is recommended to check the starting material immediately before the manufacture of cosmetic preparations . 

Commentary experts of the Association "Ukrainian industrial hemp"

An analysis of foreign studies regarding the experience of using cannabidiol as a healing element in cosmetic preparations suggests that the above drug-free cannabinoid not only has a relaxing and calming effect on the skin of the human body . With antioxidant properties that regulate sebum secretion , non-drug cannabinoids, and in particular cannabidiol, are extremely effective ingredients for use as preventive or health-improving products for the skin of not only people , but also our pets . 

It should be noted that recently the FDA and the United States Federal Trade Commission (FTC) are especially attentive and demanding to products using hemp raw materials , including non-drug cannabinoids . Over the past three years, the FDA and FTC have sent numerous joint and individual warning letters to various companies in the United States . Documents of this kind can be divided into two main categories: 

- letters to manufacturers of food additives containing hemp raw materials (the FDA takes the position that such products are illegal); 

information regarding allegations of cancer treatment , Alzheimer's disease, and other serious medical ailments and conditions (i.e., such statements are considered false and misleading by state regulatory authorities, and as such the product violates the law of the Federal Trade Commission).

That is indicative of all the "chain letters," directed by the FDA and the FTC, any kind of document was not sent to companies that specialize in the manufacture of cosmetic products , manufactured on the basis of hemp raw materials or from the use in the recipe made preparations for skin and hair beznarkoticheskih cannabinoids .

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