Firstly, on a personal note, it is my pleasure to become an active member of the Quebec Chapter of the Society of Cosmetic Chemists. I look forward to providing SCC members with pleasant and interesting meetings, and to collaborate with the society for the advancement of cosmetic science.
Now, the industry regulations are continuously changing, with new guidelines and rules being put in place and with active monitoring of products labelling and products claims by respective regulatory agencies (FDA, Health Canada, FTC or ASC). In light of the numerous warning letters issued by the FDA in the past year, it remains important to keep in mind key legal distinctions found in the Federal Food, Drug, and Cosmetic Act (FD&C Act). Please find below a reminder of some important definitions:
Cosmetic:
“…(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.” (FD&C Act, section 201(i)).
Drug:
“ The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). “ (FD&C Act, Section 201(g)).
Medical Device:
“…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is – (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.” (FD&C Act, section 201 (h)).
Evalulab is an independent clinical testing laboratory that can assist you in safety and efficacy products claims substantiation.
Please contact me for details at ekulig@evalulab.com or via phone at 514-735-3253, it will be a pleasure to help you!
