The FDA defines a cosmetic as a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Some products that are seemingly cosmetics can actually be considered a drug under the law depending on the product’s intended use. The term “cosmeceuticals” is often used within industry but the FDA does not recognize such a category and the term has no meaning under law. Products commonly referred to as “personal care products” refer to a wide variety of health and beauty items, but many are governed under the definition of cosmetics.
While a paper alternative will be made available, FDA has stated that they strongly encourage electronic submission of registration and product listing information to facilitate efficiency and timeliness of data submissions and management.
SPL is an XML document markup standard approved by Health Level 7 and previously adopted by the FDA for electronic Drug Registration and Listing (eDRL), Unique Device Identification (UDI), Lot Distribution Reports (LDR) and other structured content submissions. Reed Tech has been managing SPL submissions for vendors since the FDA SPL program inception over 15 years ago.
Determine how your regulatory compliance team will answer specifics around documentation, standard operating procedures, complaints and recalls and product data. Answering these questions will be a major indicator to gauge your strategy for compliance. We invite you to take the survey!
