Tuesday, 20 March 2012

F.D.A Questions and Answers

1) The F.D.A classifies dental floss as a class 1 dental device

2) According to the F.D.A a class 1 device is a relatively low risk device.

3) Low risk indicates that the device cannot be considered risk free.

4) The OralB Superflosstm packaging is unhygienic and has remained unchanged in approx. 30 years -refer letter 15
th July 2008.

5) According to the F.D.A,Dr. Susan Runner, ( e-mail November 2010) in response to my concerns regarding the evident shortfalls of the cardboard box packaging, has advised “
that it would be quite appropriate for health care professional to provide their patients with appropriate use parameters, particularly for those patients who might be at risk.”

6) Still awaiting response from F.D.A. to specify which patients they consider to be particuarly at risk March 2012

Currently the F.D.A has not indicated that there is a need for additional regulatory input or for more stringent instructions relating to the safe removal / usage (home/ surgery) of the Superfloss threads

In view of this would the FDA now specify which patients they consider to be particularly “at risk” and for whom the health care professionals should predominantly provide appropriate use parameters Feb / March 2012


  1. And who are the patients at risk ??? We the public would like to know !!

  2. Yes we the public would like to know, surely the FDA or P&G should be able to tell us,
    and what are these appropriate use parameters anyway

  3. As a mom I think we have a right to an explanation from P&G concerning one of their dental products.
    The Oral B Superfloss, is used, not only by adults, but also by loads of kids who wear fixed ortho appliances. For sure,the FDA will have by now,informed Procter of their findings along with their recommendations. So why haven't P&G done something about it, don’t they care about their consumers?

    Washington, U.S

  4. This comment has been removed by a blog administrator.

  5. My husband frequently suffers from herpes lesions at the corner of his mouth, I do not use Superfloss very often but I guess through reading RJB's letter printed above it would be safer if we each had our own seperate supply.

    Thanks RJB


  6. Anonymous said...

    Flossing with Superfloss shouldn't be a health risk.


  7. Doesn't the F.D.A. have an obligation toward the public, shouldn't they tell us, or,at least, inform Procter & Gamble, who these patients at risk might be. Maybe we just expect too much from a U.S.goverment agency organisation!