Even where a product appears to be EAR99 based on a self-classification, there still may be benefit to obtaining a formal CCATS from BIS. First, this could avoid questions from US Customs and Border Protection (“CBP”), which enforces US export control laws at the border and which might question whether the products are described in an ECCN on the CCL. Second, it could be helpful to have a CCATS on hand to provide to other parties involved in the transaction that may want assurances that the export is in compliance with US export control laws, such as banks, intermediaries, and customers.
What should you know about US export controls and economic sanctions?
As the market for hemp derived CBD has exploded, there is increasing interest in international trade in these products and the materials used to make them, including in the United States. For example, a US-based manufacturer of hemp-derived CBD edibles might import the active ingredient for manufacturing and then export the finished product overseas. US-based companies could also be interested in importing or exporting raw materials such as industrial hemp, hemp seeds, or other hemp-derived products.
How should you ensure compliance?
For similar reasons, state and local law enforcement have also stopped hemp crossing state lines, as illustrated by the Big Sky Scientific case in which Idaho troopers seized hemp on its way from Oregon to Colorado. In that case, the hemp was determined to have a THC content at or below .3%, which is legal under federal law, but illegal under Idaho state law. In short, it is clear that imports of CBD products have a greater chance of being stopped by CBP than other products. To avoid unnecessary delays or compliance issues, importers should ensure that CBD imports are accompanied by all required documentation, including phytosanitary certificates, and satisfy all other applicable CBP import documentation requirements, such as the entry summary or entry manifest (as applicable), commercial invoice clearly showing data elements required for customs clearance purposes, and packing list (if applicable).
A. Information for patients on Right to Try (RTT) is available on our website. RTT is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors – FDA is not involved in these decisions. Sponsors developing drugs for life-threatening conditions are responsible for determining whether to make their products available to patients who qualify for access under RTT. If you are interested in RTT, you should discuss this pathway with your licensed physician. Companies who develop drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under RTT and if they are able to provide the drug/biologic under the RTT Act.
When this statutory prohibition applies to a substance, it prohibits the introduction into interstate commerce of any food to which the substance has been added unless FDA, in the agency’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act [21 U.S.C. § 331(ll)(2)]). To date, no such regulation has been issued for any substance.
5. Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?
Research and Expanded Access
A. FDA is aware of some cannabis products being marketed as animal health products. We want to stress that FDA has not approved cannabis for any use in animals, and the agency cannot ensure the safety or effectiveness of these products. For these reasons, FDA cautions pet-owners against the use of such products and recommends that you talk with your veterinarian about appropriate treatment options for your pet.
Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).
 Gunn, et al. Prenatal Exposure to cannabis and maternal and child health outcomes: a systematic review and meta-analysis. BMJ Open. 2016; 6:e009986.
A. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
All phytocannabinoids, with several exceptions, are listed on the Prescription Drug List. If you wish to manufacture and sell a health product containing CBD that makes a health claim, you require approval for the product as a prescription drug under the Food and Drug Regulations.
There is increasing interest, both in Canada and worldwide, in CBD. CBD is a compound found in the cannabis plant. It is regulated in Canada under the Cannabis Act.
The Industrial Hemp Regulations authorize importing and exporting industrial hemp seed or grain, but not the flowering heads, branches or leaves.
CBD and prescription drugs
An industrial hemp licence holder may cultivate hemp to produce a number of different products. They may:
Cannabis oil is 1 of the 5 classes of cannabis that may currently be legally sold in Canada by provincially and territorially-authorized retailers:
For hemp-seed oil to be exempted from the Cannabis Act, no phytocannabinoid including THC and CBD may be added or concentrated by processing.
Hemp-seed oil is marketed in Canada in: