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:

https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=202120220AB45

-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.

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 )

 

From the FDA website:  https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#legaltosell

 

  1. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
  2. 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.