Company News, Regulations

FDA Sends Warning Letter to Balm/Patch Maker

Agency says Dragontree Apothecary's claims violate Federal Food, Drug, and Cosmetic Act.

The Dragontree Apothecary LLC, Boulder, CO, was issued a warning letter by the US Food and Drug Administration following an inspection of its facility in Portland, OR, from August 12-21, 2019 and a review of the company’s product labels and websites. FDA said it identified serious violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations.
 
In addition to issues with dietary supplements and products designed to treat colds and flu, FDA took issue with website and products claims for Drgaontree’s  Muscle Melt Liniment, Muscle Melt Balm, Muscle Melt Patch, and CBD Muscle Melt Balm. 
 
FDA also reviewed product labels collected during the August 2019 inspection. The claims on the labels and websites establish that the products are drugs under section the Act because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.
 
Examples of some flagged claims made online and on product labels included:
 
Muscle Melt Liniment (https://dragontreeapothecary.com)
“Reduces inflammation, release spasms, alleviates soreness, and increases circulation”
“Lobelia . . . anti-spasmodic” [Lobelia is an ingredient in Muscle Melt Liniment]
“Frankincense . . . anti-inflammatory” [Frankincense is an ingredient in Muscle Melt Liniment]
“Rhubarb root . . . anti-inflammatory” [Rhubarb root is an ingredient in Muscle Melt Liniment]
“Drynaria . . . to treat fractures, bruises, and sprains” [Drynaria is an ingredient in Muscle Melt Liniment]

Muscle Melt Balm (https://dragontreeapothecary.com)
“[M]assage into sore muscles and joints”
“[S]oothe uncomfortable muscles and joints more quickly and safely than oral pharmaceuticals”
“Here are a few of the 17 precisely chosen ingredients [in Muscle Melt Balm]: Helichrysum . . . anti-inflammatory and antimicrobial properties. Chamomile . . . anti-inflammatory and pain relieving effects. Clove . . . alleviate pain . . . antiinflammatory. . .”

Muscle Melt Patch (product label and/or https://dragontreeapothecary.com)
“Natural relief for muscles and joints”
“Fast-acting and effective relief for your sore muscles and joints”
“[C]ooling/warming sensation eases your tension and pain away”

The full letter can be accessed here.

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