Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monday, October 15, 2012

L'Oreal Receives Warning From FDA

Last month, the FDA sent a warning to cosmetic giant L'Oreal to stop advertising skin care products with language that makes the products sound like they are providing the same benefit as prescription products (drugs). A September 11, 2012 Reuters article detailed several L'Oreal products which have come under scrutiny including: Genifique Repair Youth Activating Night Cream and Absolute Eye Precious Cells Advancing Regenerating and Reconstructing Eye Cream.

Lancome's Genifique Repair
The FDA will go so far as to seize products and issue injunctions against manufacturers and distributors when claims are made that products act as drugs.

Lancome USA, a L'Oreal subsidiary, reportedly crossed the line with advertising on it's website. One actual on-line ad read, "You sleep. Genes don't. Wake up to smooth, fresh, visibly repaired skin. During the night, the speed of cell regeneration doubles. By screening over 4,000 genes, LancĂ´me's laboratories identified the genes responsible for making this activity happen and used their discoveries to create nighttime skincare that boosts the activity of genes². Night after night, skin is appears younger and more rested, as if you had slept at least two extra hours.¹"
(¹Based on consumer evaluations, ²Based on in-vitro tests on genes.)

This type of advertising violates FDA rules.

Other claims on products have included skin creams which could "boost the activity of genes" or "stimulate cell regeneration" to reduce signs of aging. According to the FDA, "any product that is intended to affect the structure or function of the human body is classified as a drug." The product must undergo testing and approval from the FDA before these types of claims can be made. The process is rigorous and involved.

Many of the products we sell at our Medical Day Spa are prescription products that have been cleared by the FDA for sale as medical grade products. Yet we notice products all the time in magazines, non-physician offices, stores, and on-line that imply that products offered are as effective as prescription skin care products. It is difficult for most consumers to know the difference. In many women's magazines, you can see prescription items reviewed right next to products that have ingredients with far less effectiveness. Many consumers do not know the differences between Retin A and retinoid complexes for example. The names sound similar, and implies the same type of benefit, but they are not equivalent in effectiveness. It is also important to note that prescription-strength products cannot legally be sold on-line without a prescription.

Dr. Robert Young recommends a consultation with a skin care professional who is trained to match products with the specific skin care issues you are facing. When a skin care professional works under the guidance and supervision of a physician you have access to products which have been approved both in effectiveness and safety by the FDA.

REFERENCES AND RESOURCES FOR MORE INFORMATION:
FDA - Buying Medicines and Medical Products Online
Mayo Clinic - Buying Prescription Drugs Online: The Do's and Don'ts
Medicine Net - Information on how to safely buy prescription drugs online

Friday, December 16, 2011

Quality Breast Implants Made in USA

You may have noticed an article which has hit the web on France's scandal involving silicone breast implants.  The huffingtonpost.com reported that more than 30,000 women in Europe have received silicone implants which were produced by the French implant company Poly Implant Prosthesis (PIP) using industrial grade silicone rather than the medical grade silicone which is used here in the United States.

Medical grade silicone is medically sterilized and safe, and is used in a variety of medical applications. The majority of breast implants we use are Mentor's MemoryGel silicone cohesive gel-filled implants which are made in the United States. Because they are manufactured here, they must adhere to strict FDA guidelines.  In fact, the FDA has a consistent presence in Mentor's manufacturing facility. This, and Mentor's ongoing commitment to quality and safety, helps to ensure the safety of their breast implants for breast augmentation. 

Silicone breast implants continue to be the desired choice by most women around the country due to the more natural feel they offer. With the latest advances to cohesive gel implants, the risks from rupture have been minimized because the gelatin-like substance retains its shape and does not seep like a liquid. If you have questions or concerns about silicone implants, consult with your surgeon.