Is the FDA in crisis?

High profile politicians and industry leaders have expressed deepening concern lately about the FDA and its ability to protect consumers from dangerous beauty products.

Following allegations that top lipstick brands contain hazardous quantities of lead former presidential candidate John Kerry said: "There has been a continuous flow of unnerving news in recent months about the FDA's clear lack of oversight and inspection."

His comments were followed in recent weeks by a series of expert testimonies to the House Energy and Commerce subcommittee reported in the New York Times suggesting the FDA is in crisis.

The agency's former chief counsel, Peter Barton Hutt, was quoted as saying that the FDA was "barely hanging on by its fingertips" and members of the regulator's scientific advisory board said under-funding had left the organization with a decrepit IT system and insufficient scientists and inspectors.

Neglect of cosmetics CosmeticsDesign.com spoke to YG Laboratories president and UC Berkley lecturer, Rebecca Gadberry to discuss the health of the FDA from the perspective of the cosmetics industry.

Gadberry said the FDA's budget for cosmetics was particularly small making it something akin to "the red headed step child of the agency."

She said the FDA is currently under-funded and under-staffed with scientific knowledge being a particularly worrying weakness given the speed of scientific developments in cosmetics.

Nanotechnology, pharmaceutical ingredients and genetics are all being studied and exploited in the cosmetics industry posing product safety and regulatory issues that demand a healthy FDA.

Gadberry said the staffing problems at the FDA are compounded by the fact that the people who are leaving the agency are the ones who understand the system best and have the knowledge to tackle the current challenges.

Lack of funding and mounting responsibilities appear to be stretching the agency to its limit.

Gadberry said a weak FDA dents consumer confidence in the cosmetics industry and allows people to be influenced by quacks who have little understanding of chemistry.

A fully functioning public health agency is also an important means of ensuring fair competition between cosmetics companies, added Gadberry.

In defense of the FDA FDA spokesperson Stephanie Kwisnek spoke to CosmeticsDesign.com to defend the organization against the mounting barrage of criticism.

Kwisnek said the FDA acts upon authoritative scientific evidence and takes seriously its commitment to develop and implement policies that will promote consumer safety and enhance public health.

She said: "When the FDA learns of a product that is adulterated or misbranded, such as a cosmetic, the agency will take the appropriate action to protect the public health."

Meyer Rosen, the chief scientific officer for HBA Global Expo and president of Interactive Consulting, also came to the defense of the FDA.

Rosen said the agency does not have control over its budget so the blame for many of its current difficulties should be leveled at Congress for not allocating it sufficient resources.

He said the FDA also has limited powers with regards to cosmetics and is often expected to do more than it can to ensure that products are safe and regulations are effective.

Indeed consumer groups and industry representatives have been calling for tighter regulation of cosmetics and an FDA with more teeth.

Whether the regulatory system in the US needs to be overhauled will the subject of a follow-up article.