For Professionals

FDA does not approve cosmetics. Not ours, not anyone's. There is no FDA approval, no FDA certification and no FDA certificate for a cosmetic product anywhere in the United States. FDA's own words are that cosmetic registration and listing "is neither a cosmetic approval program nor a promotional tool", and that FDA does not issue certificates for cosmetics. What does exist, since the Modernization of Cosmetics Regulation Act, is a mandatory filing: facilities register, and products are listed with their ingredients. It is not a review, an endorsement or a quality mark. Vegalab's facility registration and product listing have been filed. What actually answers your question is documentation, and we will send any of it on request: the full ingredient declaration, and our declaration of conformity to ISO 22716, the international standard for cosmetic good manufacturing practice.

We make and sell these as professional leave-on cosmetic serums, and we do not publish needling protocols or depths.

Whether microneedling sits within your scope of practice is set by your state or provincial board, not by us, and it varies considerably. California prohibits skin penetration by estheticians entirely. Texas treats penetration of the dermis as a medical procedure requiring physician delegation. Other states permit it under a depth cap.

What we can tell you is what the format is built for. A sealed ampoule drawn through a septum, one portion per treatment, is designed for the treatment room: post-procedure, on a compromised barrier, after resurfacing, wherever a fresh unopened portion matters more than a bottle that has been open for three months.

The vials and stoppers are sterilized before filling. Each ampoule is filled and sealed immediately under a re-enterable stopper, so it is drawn from rather than opened. The serum inside is a cosmetic, not a sterile pharmaceutical. No cosmetic sold in the United States or Canada is a sterile product. No sterility certification exists for a cosmetic in either country, FDA and Health Canada do not approve cosmetics, and no regulation requires a topical used in microneedling to be sterile.