FDA WARNING_LETTER - The Reynolds Office of Health and Nutrition

The FDA issued a Warning Letter to Sue and Michael Reynolds, owners of The Reynolds Office of Health and Nutrition, regarding the marketing of hyperbaric chamber accessories. The FDA's Office of Compliance reviewed the firm's website, reynoldsoffice.com, and found they were marketing Oxygen Concentrators (5 psi, 8 psi, 15 psi) intended for use with hyperbaric chambers.

These products are considered devices under section 201(h) of the Act. Hyperbaric chambers are Class 2 devices requiring 510(k) clearance, and as accessories, the listed oxygen concentrators also require 510(k) clearance. The firm was found in violation of the Federal Food, Drug, and Cosmetic Act because these products were marketed without marketing clearance or approval.

Specifically, the products are adulterated under section 501(f)(1)(B) for lacking an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) because the firm failed to notify the FDA of its intent to introduce the products into commercial distribution via a 510(k) submission.

Furthermore, the firm failed to fulfill annual establishment registration and device listing requirements for fiscal year 2013, as mandated by section 510 of the Act, rendering all their devices misbranded under section 502