Cosmetic labeling

Personal Care
OTC Drugs

Cosmetics and Personal Care

The cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act, and the regulations published by the Food and Drug Administration under the Authority of these two laws.

The FD&C Act was enacted by Congress to protect consumers from unsafe or deceptively labeled or packaged products by prohibiting the movement in interstate commerce of adulterated or misbranded food, drug devices and cosmetics.

T4L provides services to assist companies with keeping their cosmetic products compliant with the always changing regulatory environment.

* Cosmetic Labeling Compliance
* FDA Detention Services

OTC Drugs

OTC (over-the-counter) medicines are safe and effective drugs used by the general public without prior recourse to a healthcare professional. Similarly, cosmetic products can be considered as OTCs. Some products meet the definitions of both cosmetics and drugs. Certain claims may cause a product to be considered a drug, even if the product is marketed as a cosmetic. Likewise, certain active ingredients can cause a product to be considered a drug owing to their therapeutic use. OTC products compliant with the OTC drug monograph may be marketed without prior FDA approval. OTCs must be manufactured and controlled in accordance with cGMP requirements for pharmaceuticals for human consumption.

  • OTC Drug Labeling and Ingredient Review
  • FDA Product Registration and Listing
  • FDA Detention Services