The FDA's Code of Federal Regulations (21 CFR § 801.109) and 21 CFR § 880.5580 mandate that the sale of these needles be strictly restricted to "qualified practitioners of acupuncture as determined by the States".
Some allied health professionals, like physical therapists, attempt to purchase needles for "dry needling." However, many regulatory boards and medical organizations argue this still constitutes the practice of acupuncture and remains illegal without proper licensure. Risks of Unlicensed Use buy acupuncture needles without license
Purchasing, receiving, or using these needles without a license can lead to the devices being classified as "adulterated" or "misbranded" under the Federal Food, Drug, and Cosmetic Act (FDCA), potentially resulting in civil or criminal penalties. State Laws and Restrictions The FDA's Code of Federal Regulations (21 CFR § 801
All acupuncture needle packaging must bear a warning stating: "Caution: Federal law restricts this device to sale by or on the order of qualified practitioners of acupuncture as determined by the States" . State Laws and Restrictions All acupuncture needle packaging