The United States Food and Drug Administration reviewed Shapeshifters Apparel LLC's website (shapeshifters.co) and observed that the website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. Sec. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Our review of the firm's website revealed statements that these breast binders (example trade names: "Island Time Binders", "Custom Print Binders", "Skin Tone Binders") are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:* Per the firm's website: "Chest Binding 101. What Sorta Reasons? Gender dysphoria."* Per the firm's website: "The right amount of compression is the amount that feels good (dysphoria)"* Per the firm's website: "The "right" amount of compression can vary from person to person, depending on chest size, chest tissue density, physical activity level, dysphoria level, lung capacity, affinity for the sensation, and more."Our review also revealed statements that the manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. Sec.
360) (e.g., "Custom-sized, hand-made, made-to-order."). Under section 510 of the Act (21 U.S.C. Sec. 360), manufacturers of medical devices are required to annually register with the FDA.
In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. Sec. 360(p))] during the period beginning October 1st and ending December 31st of each year.
The indicate that the have not registered or listed these devices for fiscal year 2026.
