FDA warns on safety labelling

Speaking at the 25th ICMAD/FDA Cosmetics workshop, held in Illinois at the end of last week, Stanley Milstein, assistant to the director of the FDA​ reminded the industry that the 740.10 labelling requirement is as important as ever, "when a cosmetic product and/or its ingredients have not been adequately substantiated for safety prior to marketing,"​

"The warning statement is required whenever necessary or appropriate to prevent a health hazard that may be associated with a product,"​ Milstein also said during the workshop.

While 740.10 has been in existence for 30 years, the FDA has recently emphasized the importance of substantiating the safety of all cosmetic ingredients in response to growing consumer and lobby group pressure over untested ingredients.

"There has been recent pressure on the FDA for enforcement of the 740.10 clause,"​ said Penni Jones, executive director of ICMAD. "CIR doesn't have the capacity to evaluate every ingredient without addressing higher priority materials first."​

"Some people may think an ingredient is safe because it has been around for 30 years, but safety must be substantiated,"​ added Jones.

The FDA says that the purpose of its labeling regulation is to fall in line with the cosmetic industry's responsibility to self-regulate.

"While the regulation has been on the books for many years, FDA has never seen the need to enforce it based upon the long standing safety record for cosmetic products throughout the industry,"​ noted Carl Geffken, president of Carl Geffken Consultants and a speaker at the ICMAD/FDA workshop.

"The CIR process is well respected and all manufacturers must continue to be responsible for following CIR recommendations or otherwise assure that all product formulations are safe."​

Despite the confidence in self regulation shown by industry, in recent months both industry lobbyists and consumers have been mounting pressure over the issue of regulation.

Campaigners in California have been trying to bring about action at a state level in an attempt to change laws relating to unsafe cosmetics ingredients there, whilst on a national level the lobby group Campaign For Safe Cosmetics has been focusing on the removing of phthalates from cosmetic ingredients because of the chemical's link to cancer.

In response to pressure from the lobby group, the FDA recently tested 48 cosmetics products and found that most contained at least one type of phthalate. The chemical is used for a host of functions in cosmetics products, including slowing the evaporation of fragrances down to make the smell linger, as well as making certain resins more flexible. The group of chemicals is commonly found in nail varnishes, shampoos, face creams and body washes.

Both lobby groups and consumers are pressurizing the FDA to fall in line with European regulations. Cosmetics ingredients are more strictly regulated by the European Commission, which has banned two types of phthalate from cosmetics sold in Europe.