One year ago, Walgreen and CVS announced their plans to begin the sale of hemp-based-CBD-infused topical in their outlets across select states – albeit, only non-ingestible applications. While the rollout has been slow, more and more topical CBD creams are being spotted in national chain retail stores.
Perhaps, in response, the FDA recently sent a new round of warnings to some CBD distributors, set new guidelines, and updated their hemp and marijuana FAQ.
Where It All Begins
The Drug Exclusion Rule has influenced the FDA’s long-held stance that Hemp-derived CBD should not be infused into dietary supplements or food. The 2018 Agriculture Improvement Act finally removed hemp and hemp-derived products from regulation under the C.S.A as a drug, so long as the THC level was <0.3%.
The FDA holds a position that the FDCA and other related FDA rules disallow substances recognized as drugs to be used in dietary supplements and food. The agency has also barred manufacturers from making CBD health claims, unless the product is classified as a drug. Only one cannabidiol product, Epidiolex, is currently classified as an approved drug, but it requires a prescription
What Is the FDA’s Position On Cannabis-Infused Cosmetics and Topicals?
Cosmetics are products meant to be poured, rubbed, sprayed, or sprinkled on the human body. This could be to alter the appearance, promote attractiveness, beautify, or cleanse.
The FDA monitors the industry based on customer feedback, and, unlike drugs and food, do not subject cosmetics to pre-market approval.
There’s been mounting pressure on Congress to review the legislation and extend FDA’s border in cosmetics regulation. But, to date, no avail.
While cosmetic regulations are a bit lenient, the FDA still set their regulatory framework.
For instance, the FDA must pre-approve color additives in cosmetics before they enter the market. Also, the FDA tags any cosmetic product with harmful ingredients as adulterated.
The federal agency has banned certain ingredients, like chloroform, from topical. Thankfully, CBD does not fall in here.
Also, the topical with any harmful deleterious or poisonous substances are considered prohibited if the ingredient makes the product misbranded or adulterated in whatever way. This clause may include cannabis ingredients.
That means, even some non-prohibited ingredients are not safe.
So, What Are Misbranded Topicals?
‘Misbranded’ cosmetics (as referred by FDA) may include misleading or false labeling, insufficient labeling information, or with deceptive filling. This technically applies to all topical, including hemp-CBD based. Quite a bit of clarification is needed, but in the meantime, CBD topical creams are easily available online and in many retail establishments.
The Final Wrap
Before any business invests in hemp-CBD topicals or cosmetics for retail sale, these laws are important to note.
Take note of the new FDA regulation, though incomplete, it provides the best guidance on how the FDA currently views the use of hemp in cosmetics and topicals. Many in the hemp industry are still waiting for the FDA to release their much-delayed Interim Final Rules (IFRs) further detailing if, and how, they intend to regulate hemp products already on the market.