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Posts Tagged ‘FDA’

FDA asked to Look at Hair Straighteners & Formaldehyde: Notes from a San Francisco Bay Area Dermatologist

Monday, July 11th, 2011

Just wanted to spread the word about recent concerns with hair straightening products since this new trend has become  so popular with patients.

“The AP (7/8) reported that at least 10 members of the House of Representatives “are asking the Food and Drug Administration to look into” whether women using keratin-based hair straighteners, including the popular Brazilian Blowout, are exposed to high levels of formaldehyde. Rep. Jan Schakowsky (D-IL) said she had heard that users of such products had experienced hair loss, respiratory problems and other illnesses. Along with Rep. Edward Markey (D-MA), Schakowsky and eight other House members “wrote to the FDA in May asking for better regulation and labeling of keratin-based hair-smoothing products that contain formaldehyde,” classified as possibly carcinogenic by the Environmental Protection Agency. An FDA spokeswoman said that the agency was evaluating data on hair straighteners, while noting that as cosmetic products, they are not subject to FDA pre-market approval.”

 

A New Look for your Old Sunscreen: Notes from a San Francisco Bay Area Dermatologist

Monday, June 20th, 2011

Your sunscreen bottle may look different in the next year or two!  Earlier this month, the FDA issued new labeling regulations on sunscreens.  Below is quick summary of the new requirements:

  • Sunscreens may be labeled “broad-spectrum” if they provide protection against ultraviolet A (UVA) and ultraviolet B (UVB) radiation.
  • Only broad-spectrum sunscreens with a Sun Protection Factor (SPF) of 15 or higher can state that they protect again skin cancer if used as directed with other sun protection measures.
  • Sunscreens with an SPF of 2-14 will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.
  • The terms “sunblock”, “sweatproof” and “waterproof” are no longer allowed on sunscreen labels.
  • A sunscreen may claim to be “water resistant”; however, the product must specify if it offers 40 minutes or 80 minutes of protection while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
  • Sunscreens cannot claim to provide sun protection for more than two hours without reapplication.
  • Sunscreen manufacturers will have one year to comply with the FDA ruling; smaller companies will have two years.
  • The ingredients in sunscreens marketed today have been used for many years and FDA does not have any reason to believe these products are not safe for consumer use.
  • The FDA reiterated that sunscreen alone is not enough, and should be used in conjunction with a complete sun protection regimen, including seeking shade, wearing long pants, long-sleeved shirts, hats and sunglasses.

As always, be sure to use a shot glass sized amount of sunscreen for your body and a large nickel size for your face.  Re-application is key!  Make it easy to remember by carrying sunscreen in your purse, bag and car.  If you don’t like to reapply a lotion form of sunblock, try the Colorscience Pro Sunforgettable Mineral Powder, a quick and easy way to touch up throughout the day.

For more details on the changes to sunscreen labeling, please visit the FDA’s website.

 

Important Info about Botox and Dysport (Reloxin)

Monday, May 4th, 2009

The FDA has recently approved the cosmetic use of a new brand of Botulinum Toxin Type A, known as Dysport or Reloxin.  Dysport is a competitor to Botox, which up until now was the only FDA approved wrinkle reduction product of its kind.   Dysport claims to take effect more quickly and could potentially be lower in price than Botox.  It will hit the cosmetic market within the next two months.

The approval of Dysport comes at a time when the FDA has issued new labeleling requirements for all botulinum based drugs, including Botox.  Both products must now carry labels warning that they have the potential to spread to other areas of the body after injection with possibly serious risks.  I want to assure my patients that when used as directed by a trained professional the cosmetic use of these products is safe! The new labels are a reaction to unapproved or “off-label” use, such as overdosing to treat leg or arm muscle spasms.  This unapproved medical use should not be confused with the cosmetic application.  The small amounts used for wrinkle softening and underarm sweating (hyperhidrosis) are safe and not linked to any harmful migration or serious adverse reactions.  I am more than satisfied with the long-term safety studies of this material for aesthetic purposes.  If you have any questions, please don’t hesitate to contact the office.

 

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