In an Oct. 16 Consumer Update, FDA acknowledges that “CBD-containing products are everywhere,” and that while “these products often make questionable health promises about CBD” the agency “has not approved these products,” other than a trio of prescription products containing either CBD or synthetic THC.
As such, it adds, “there may be serious risks to using cannabis products, including those containing CBD, if you are pregnant or breastfeeding.”
Specifically, the agency warns that “high doses of CBD in pregnant test animals have caused problems with the reproductive system of developing male fetuses,” and it expects that “some amount of CBD will be transferred to babies through breast milk.”
In addition, it warns it is investigating the “potential for CBD products to be contaminated with substances that may pose a risk to the fetus or breastfed baby, including THC” as well as pesticides, heavy metals, bacteria and fungus.
This research is part of a broader effort by FDA to understand the effects of CBD-containing products over a person’s entire life and in combination with each other. It also is examining the “the extent the presence of CBD in human milk harms the breastfed baby or the mother’s milk production.”
So far, it notes, “there are many unanswered questions about the science, safety and quality of products containing CBD during pregnancy and while breastfeeding,” and as such it encourages women to “not put yourself or your baby at risk by using cannabis products while pregnant or breastfeeding.”
While the agency does not fully understand the potential impact of the ingredient on pregnant and breastfeeding women and their children, it knows more generally that the ingredient can cause liver toxicity, extreme sleepiness and interact harmfully with other drugs, based on clinical human studies.
Hemp seeds are fine
At the same time the agency sounded the alarm on CBD, it reassured consumers that it has not objections to the use of hemp seed-derived food ingredients, which it has thoroughly evaluated.
“THC and CBD are found mainly in hemp flowers, leaves and stem, not in hemp seeds,” FDA explained. It acknowledge that while “hemp seeds can pick up miniscule amounts of THC and CBD from contact with other plant parts … these amounts are low enough to not raise concerns for any group, including pregnant or breastfeeding women.”
GMA lauds FDA’s warning, calls for further oversight
Industry stakeholders, including several retailers and trade groups, have repeatedly called on FDA to quickly clarify and enforce its stance on CBD in food, beverages, supplements and cosmetics given the ingredient’s rising popularity and influx of products that contain it.
This call was reiterated by the Grocery Manufacturers Association Oct. 16 following the FDA’s advisory cautioning pregnant or breastfeeding women against the use of CBD.
While the trade group, which will become the Consumer Brands Association in January, lauded FDA for issuing a clear warning it also urged the agency to “move swiftly to provide clear regulatory oversight and consumer protection around CBD-containing consumer products” given shoppers’ widespread confusion about the ingredient.
The group’s call for action was partly tempered by GMA President and CEO Geoff Freeman’s statement that “there is likely a reasonable role for CBD in the marketplace.” But, he added, that role “demands stringent federal regulation that promotes safety and empowers consumers to make informed decisions.”
Editor's Note: Interested in learning more about breastfeeding and what children should and should not eat? Join us in Chicago in November for FoodNavigator-USA's Food For Kids Summit. Find out all the details and register HERE.