Silver Spring, MD—FDA released a consumer update strongly advising against the use of cannabidiol (CBD), tetrahydrocannabinol (THC), and marijuana in any form during pregnancy or while breastfeeding.
The update cites advice from the U.S. Surgeon General, who noted that marijuana use during pregnancy “may affect fetal brain development, because THC can enter the fetal brain from the mother’s bloodstream.” Research suggests that marijuana may increase the risk of low birth weight, premature birth, and potentially stillbirth.
The update states that breastmilk can contain THC for up to six days after use, which can affect a newborn’s brain development and result in hyperactivity, poor cognitive function, and other long-term consequences.
The update adds that marijuana smoke contains many of the same harmful components as tobacco smoke, and that marijuana should not be smoked around babies or children.
Regarding CBD, the update says, “There is no comprehensive research studying the effects of CBD on the developing fetus, pregnant mother, or breastfed baby. FDA is continuing to collect and study the data on the possible harmful effects of CBD during pregnancy and while breastfeeding. However, based on what we do know, there is significant cause for concern.” The update cites studies finding that high doses of CBD in pregnant test animals have caused problems with the reproductive system of developing male fetuses, and human clinical studies showing that CBD can cause liver toxicity, extreme sleepiness, and can have harmful interactions with other drugs.
Besides the risks of CBD itself, the update says, there is potential for CBD products to be contaminated with substances ranging from THC to heavy metals, fungus, and pesticides.
The update does note that hemp seeds are safe, containing no THC or CBD.
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Speaking at the “CBD From Seed to Shelf: The Supply Side Story” summit at SupplySide West in Las Vegas on Wednesday, the day the FDA issued the announcement, Marc Ullman, Of Counsel, Rivkin Radler LLP, said “There are developments that everyone who has an interest in the CBD trade should be concerned about today.” One is this FDA public safety announcement, and the other is the New York Times article published the same day questioning whether CBD is a scam or not. “These two new developments…issues that we need to be thinking about as the CBD trade moves forward into the future.”
In terms of what keeps him up at night, Ullman said, “I worry about the quality…my concern really focuses on the presence of unknown adulterants created in the manufacturing process.”
Fellow panelist Rend Al-Mondhiry, Senior Counsel, Amin Talati Wasserman LLP, also shared her top worries. “My concern is greater than just the CBD industry and ties back to the New York Times article. How does this negative attention regarding CBD impact the dietary supplement industry overall? Issues with contaminants have been seen with other ingredients as well. The CBD industry is just one part of the dietary supplement industry and there are always going to be companies out there that don’t understand the rules…when those companies take the headlines and seem to represent the industry as a whole, that to me is concerning.”
Stay tuned: We’ll have more from the CBD summit and from the show floor.