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Spa Machine Safety
By: Christine Heathman
Posted: June 26, 2008, from the July 2008 issue of Skin Inc. magazine.
page 3 of 9
The FDA regulates these things to ensure the safety and efficacy of products in all these areas through a set of laws with respect to safety and claims, and these regulations are different from statute laws.
In today’s rapidly changing face of professional products and machines falling under the auspice of the FDA, many argue this organization is underfunded, incompetent, the victim of regulatory capture and staffed by lifetime bureaucrats more interested in preserving their jobs than protecting the public health. Quite possibly this is true given several temporary hiccups in the system. The FDA is in many ways outdated and challenged by offenders who fly temporarily under the radar until reprimanded.
And because of this, it has become the professional responsibility of the skin care specialist to ensure the manufacturer or distributor of the skin care machine they choose to purchase has taken the correct and appropriate legal steps to comply with the FDA safety register standards. As you all should know, this is a buyer beware market.
Manufacturers work through a process with the FDA to ensure disclosure of the information needed to determine the safety and effectiveness of a technology. Before purchasing a machine, ask for all the data available on the unit, in addition to clinical studies. This statement does not mean you are entitled to company proprietary information; the purpose of this request is to ensure your device is, if necessary, registered with the FDA and to acquire the documents to back its effectiveness.
The sad reality is not all skin care machine manufacturers follow this guideline. The skin care industry is on the FDA’s radar for competency, as noted by the many ingredient-listing changes imposed in the last few years and offending companies that have been cited for violating regulatory laws. There are thousands of skin machines currently on the market not registered with the FDA, and yet they are marketed as “regulated” by the organization, piggybacking on the credibility of trustworthy and honorable companies that have gone to the expense of following regulations and abiding by the law.