The short answer is that, yes, topical CBD is legal as far as the FDA is concerned and in most states as long as it was made from Hemp (the dry weight of the plant cannot contain more than 0.3% THC) and the product contains less than 0.3% THC and no medical claims are made.
The legal status of CBD is complex in a way in that there are several factors at play:
The current 11/2021 California law was just passed:
-The Federal government is currently operating on the 2014 farm bill even though there is a 2018 farm bill working its way through the system. The new bill makes it more of a farm commodity and relaxes most rules (except for ownership of businesses by ex-felons) but the problem is that it leaves a lot of the implementation up to the states. The states can make regulations that are more restrictive, but not less. Sorting out the involvement of the FDA, farm bureau and the states is also taking a lot of time.
-You can think of the CBD as: ingested forms, topical forms, forms with less than 0.3% CBD, forms with no CBD and CBD/THC blends. Each is different and has different ramifications.
- Edible CBD is very common, but technically against the FDA rules. The reason is that there is an oral anti seizure drug approved by the FDA. Technically, the FDA considers selling edibles as selling a prescription drug without a prescription. That said, they also state that they prosecute according to their resources. In fact the only action the FDA has taken has been to send out warning letters to companies making specific claims to cure diseases like cancer. They have not even sent letters to companies that make more abstract claims like pain relief. I have asked the people in the industry why they are ignoring the FDA, they say something like, ‘well, the FDA would have to deal with a large number of people if they did take action and if they did, it would be likely to start with warning letters and not legal action’. The other problem with oral CBD is that most of it gets digested, unlike THC which gets enhanced via the liver into THC-A. So it is not an ideal pathway: about %7 gets into the system vs %45 with topical that are well formulated.
- Topical forms are treated by the FDA as a cosmetic unless you make medical claims. I have added an article later in this blog with the FDA’s explanation from their website. It is tempting to think of getting CBD certified as a drug for your application, but it is very expensive and would cause huge problems in the industry. I think CBD is best kept, like vitamin C, as a potent medicine, with few if any side effects, out of the drug category. Like vitamin C, its benefits are well known and will become more so over time so there is little need to make claims.
- CBD with THC > 0.30 is treated as Marijuana. The reason I add this here is that many knowledgeable people feel that CBD plus THC is much more effective than one or the other by itself. Many also feel that the other elements, the terpenes, also have a synergistic or ‘entourage’ effect. Of course, the status of THC is too dicey for any larger company to deal with.
- CBD with less than 0.30 THC is treated legally as not having THC but may be enough to enhance the function of the CBD, which is why it is the most popular. It is also the natural product of some variety of hemp plants, grown in certain conditions. The ideal CB as I understand it, starts with a plant, grown in a controlled environment so that the CBD content will be high and the THC will be naturally below %.03, without pesticides, heavy metals or fungus (humidity control). This plant is then put through an extraction process that does not damage the smaller elements. While you hear a lot about CO2 extraction, it is not a process well suited for volume production. The most common volume production is using methyl alcohol. TIf processed properly, which takes more time and control than making isolates, you end up with a wider range of components, including CBD-N (often concentrated to use in sleep formulas) and CBD-G (purported to help reduce the size of tumors and help autism) and the terpins. You will see cheaper CBD isolates which are most likely processed via large HPLC apparatus to salvage plant matter that had excess THC or other issues.
- CBD with no detectable THC was developed for athletes who are afraid of being tested positive for drugs. The opinion of people who are in the testing and formulating of CBD products is that even %0.30 THC will not be picked up by a drug test and that a little THC is needed for the CBD to be effective. As they like to say: more study is needed.
Here is what I understand is required of a transdermal formula: The CBD molecule is a large hydrocarbon chain which has a difficult time getting through the dermis on its own. It is helpful to break down the size of the molecule and to add helpers to get it through the skin. In addition, the outer layer of skin has a fatty binder and the dermis is mostly water. A surfactant is needed to help the oil mix with water. There are also some heating and mixing requirements to make the formula more effective. Mechanically, we need a formula that will be thick at room temperature so it will stay on the pad, but have a low viscosity at body temperature so we can warm it up and apply it the pad and it will flow on the skin: melts on your skin and not on your patch (or something like that )
- What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
- A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”
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)]).
If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance. (See Question #3 for more information about drugs.)
FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report adverse events associated with cosmetic products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA’s webpage on how to report a cosmetic-related complaint.
My conclusion from all this is that we are pretty safe making a topical dermal patch with CBD containing less than 0.30% THC processed properly. We have made over for a million patches for number of customers plus our own and have not seen any backlash.