The Hemp Farming Act of 2018

The primary focus of the Bill entitled "The Hemp Farming Act of 2018" was to both legalize the agricultural production of hemp and to regulate that activity. Regulatory authority for this agricultural activity, the growing of hemp, is delegated to the Secretary of Agriculture with the states having to develop plans which require approval by the Secretary of Agriculture. The Bill does provide preemption for the growth of hemp; only if the state laws differ from those provided in the Bill.

While the focus of the Bill was to legalize the growth of hemp, there are several provisions of the bill, which have reach beyond the agricultural activity.

Firstly, the Bill defines hemp as the plant Cannabis Sativa and includes any part of the plant, including the seeds and all derivatives, extracts, cannabinoids, isomers, acids, salts and salts of isomers, whether grown or not with a delta-9 tetrahydrocannabinol (THC) concentration of no more than 0.3 percent on a dry weight basis.

Secondly, the Bill exempts hemp from being a class 1 substances under the Controlled Substances Act thereby legalizing hemp materials in the United States and distinguishing hemp from marijuana which remains federally a class 1 controlled substance.

By legalizing hemp and the materials contained in hemp, CBD from hemp and other substances below 0.3% of THC found in hemp are completely legal.

But this does not mean that use of hemp is permitted in personal care products or any other FDA regulated products.

The FDA has taken a strong position that CBD cannot be used in dietary supplements because use of CBD in dietary supplements followed the approval of a New Drug Application in which CBD is the active ingredient. Supplements cannot contain ingredients that were approved for drug use prior to use in a dietary supplement.

Use of CBD or any of the other materials found in hemp as a food additive requires prior FDA approval, which must be based upon studies demonstrating safety at the do no harm level.

Use of any of the hemp materials as drugs, like the drug approved for epilepsy which contains CBD, requires FDA approval based upon extensive studies establishing both safety and efficacy.

As to cosmetic use, THC at low levels have been permitted in cosmetic products under a pre-existing guidance document issued by the Justice Department and followed by the FDA. The basis for this guidance was that there was little risk that the THC in the product would enter the body. Use of other compounds found in Hemp in cosmetic products would require establishment of safety and these compounds are probably not ingredients that would have been studied in the Cosmetic Ingredient Review, so marketers are on their own to establish safety for these other hemp compounds for topical use in cosmetics.

For more information on the FDA regulations regarding the use of THC and CBD, visit the FDA website.