U.S. Food and Drug Administration The U.S. Food and Drug Administration is responsible for regulating
certain aspects of the marketing and labeling of hair removal
products and devices.
Drugs (CDER)
 505(b) Approvals for drugs used in
treating unwanted hair
Medical devices (CDRH)
This is done through FDA's Center for Devices and Radiological
Health (CDRH) http://www.fda.gov/cdrh/index.html
510(k) Premarket Notification Clearances
for medical devices intended to remove unwanted hair
- Lasers and flash lamps (1976-present)
- Needle electrolysis (1976-1996)
- Electric tweezers (1976-1998)
- Microwaves (1976-present)
Classifies and identifies hair removal
devices
Regulation numbers and product
codes
Reclassification of electric tweezers
(1998)
Reclassification of needle eplators
(1996)
Maintains records on hair removal devices
Cosmetics
Regulates cosmetic products used to
dissolve and color hair
Compliance
Enforces certain labeling and branding
claims
- compliance and surveillance programs
- Conducts field tests and inspections
- training of Federal and State compliance personnel.
- Advises actual or potential manufacturers concerning the
requirements of the law and regulations.
- Enforces the Medical Device Amendments of 1976 including
the Safe Medical Devices Acts of 1990 and 1992 and the Radiation
Control for Health and Safety Act of 1972 as they relate to
promotion and advertising.
- Develops regulations and Compliance Policy Guides including
those related to restricted devices, restricted device labeling,
health fraud,
and the promotion of devices pending pre-market clearance.
- issues related to promotion, advertising, and labeling policy.
- determine off-label promotions.
- Develops, implements, and manages the Center's health fraud
program. Coordinates activities with National Association
of Attorney
Generals, and Regional and District health fraud representatives.
Source: FDA website
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