PARTNER CONTENT: HBW INSIGHT
​Interested In Using CBD Or Probiotics In Cosmetics? Ask Yourself Why – FDA’s Linda Katz
Friday, September 13, 2019
by: Ryan Nelson

Section: Articles





Executive Summary

The answer to the ‘why’ question can help clarify whether a company is marketing a cosmetic or an unapproved
drug, FDA’s cosmetics office director advised attendees at ICMAD’s 38th annual regulatory workshop in New
York.

The US Food and Drug Administration has yet to take a position on either CBD or probiotics in cosmetics,
but advises companies to take a cautious approach to the ingredients’ use.

Presenting May 9 at the Independent Cosmetic Manufacturers and Distributors’ 38 annual regulatory
workshop in New York, Linda Katz, director of the agency’s Office of Cosmetics and Colors, noted surging
interest in cannabidiol (CBD) following enactment of the Agriculture Improvement Act of 2018.

The “farm bill” legalized state-licensed hemp production and removed low-THC cannabis from Schedule 1 of the
Controlled Substances Act.

It also preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds
under the Federal Food, Drug and Cosmetics Act.

FDA will be holding a public hearing May 31 at its White Oak campus in Silver Spring, Md., to hear from
stakeholders on the subject.

So far, the agency has offered little in the way of guidance to cosmetics manufacturers.

Katz noted that while the agency doesn’t approve cosmetics on a premarket basis, the FDCA dictates that
cosmetics cannot be adulterated or misbranded.

“When putting CBD into a cosmetic, you need to ask yourself several questions,” she said. Firstly, “what is the
intended use of CBD? If it is intended to affect the structure or function of the body, that makes it a drug. Or if it
is intended to treat, diagnose, cure, mitigate or prevent a disease, then it’s also a drug.”

She continued, “So you need to really ask yourself, why must [CBD] be in a cosmetic? If you answered the other
two questions affirmatively, then you are [marketing] a new drug and must be approved by the US FDA.”
Intended use is a pivotal consideration used by FDA to separate cosmetics and other regulated products from
drugs. Importantly, the agency does not interpret intended use strictly based on labeling claims, advertising,
and/or oral or written statements from manufacturers, sponsors or their representatives.

It also “may be shown by the circumstances surrounding the distribution of the article,” FDA says.
According to the agency, consumer perceptions, established through a product’s reputation, can factor in
determining intended use. “This means asking why the consumer is buying it and what the consumer expects it
to do,” FDA explains.

While available science is spotty at best as to CBD’s potential benefits, advocates tout wide-ranging bene􀃨ts
related to pain, anxiety and depression relief, digestive, cardiovascular and neurological health, diabetes
prevention and cancer treatment, among other possible virtues.

CBD’s reported anti-inflammatory properties are the most obvious draw for skin-care marketers. However, FDA
has made clear in warning letters that anti-inflammatory claims identify purported cosmetics as unapproved
drugs.

Even if a company does not make express anti-inflammatory claims – at the moment just the mention of CBD is
likely enough to intrigue consumers – the agency still could infer from public understanding that a CBDcontaining
product is intended for drug purposes, such as acne treatment or prevention.

Further, FDA notes on its website that certain ingredients can cause a product to be considered a drug because
they have well-known therapeutic uses. The agency invoked this principle in a 2011 warning letter to Lifetech
Resources LLC, whose RapidLash and other eyelash-enhancement products contained a prostaglandin analogue
related to bimatoprost, the active ingredient in Allergan PLC’s Latisse drug. (Also see "FDA’s Warning To Lash-Growth
Firm Shows Risks In Third-Party Claims" - HBW Insight, 2 May, 2011.)

FDA noted that synthetic prostaglandin analogues “are well known to have an effect on the structure or function
of the body.”


Probiotics: Same Drill
According to Katz, companies considering probiotics’ use in cosmetics should ask themselves the same sorts of
questions as those eyeing CBD – ie, “why are you putting them into cosmetics.”

“We’ve been spending more time this past year trying to figure out what exactly these products are [and] what
kinds of claims are being used,” she said.

Such questions potentially have prompted some of the “informational” letters that, according to Katz, FDA
began sending to cosmetics manufacturers this year to gain insight into product labeling claims and ingredient
use. She said about 20 such letters have gone out thus far, but declined to offer much more detail.

FDA’s Nakissa Sadrieh noted at the Cosmetic Ingredient Review Expert Panel’s meeting in April that most
cosmetics carrying probiotic claims don’t actually contain live microorganisms. (Also see "FDA Proposes Priorities
For Cosmetic Ingredient Review: Mica, Probiotics, CBD" - HBW Insight, 18 Apr, 2019.)

Those that do could be adulterated in FDA’s view regardless of whether the intentional contamination is
believed to have health-promoting effects. (Also see "FDA Says Probiotic Cosmetics Could Be Adulterated, ‘Good’
Bacteria Or Not" - HBW Insight, 20 Sep, 2018.)

According to Katz, FDA’s Center for Biologics Evaluation and Research takes the position that “if you are putting
a live microorganism into a product that you’re selling to consumers, and you’re making any [related] claims at
all, it really should be reviewed as a drug,” with CBER taking the lead.

“We don’t really know what to do with these things, and we’re hoping that internationally we may get a better
handle on that,” Katz said.

Probiotics is a topic being explored by the International Cooperation of Cosmetics Regulation, which involves
regulatory authorities from the US, Canada, European Union, Japan and Brazil in efforts to promote regulatory
convergence and minimize international trade barriers.

ICCR’s next meeting will be July 9-11 in Montreal, Canada.

In advance of ICCR-13, FDA will hold a public meeting June 5 to garner input on regulatory topics of interest that
could inform its ICCR preparation. The deadline to register for that meeting’s attendance or submit oral
presentation requests is May 22.