Inspections, Compliance, Enforcement, and Criminal Investigations

Cosmetic Dermatology 12/3/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
 
WARNING LETTER
FLA-16-03
December 3, 2015
 
 
Stephane Colleu
Director
Drbrandtskincare.com
Cosmetic Dermatology, Inc.
8798 Northwest 15th Street
Miami, Florida 33172
 
 
Dear Mr. Colleu:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://drbrandtskincare.com in November 2015, and has determined that you take orders there for your products, which you market as cosmetics, “glow by dr. brandt® overnight resurfacing serum,” “glow by dr. brandt® ruby crystal retinol hydracrème,” “glow by dr. brandt® revitalizing retinol eye cream,” “glow by dr. brandt® travel kit,” “The Wrinkle Solution,” “Do Not Age with dr. brandt dream night cream,” “oxygen facial flash recovery mask,” “Save Our Skin, Do Not Age with dr. brandt ® time reversing cream,” “Do Not Age with dr. brandt® firming neck cream,” “xtend your youth dual fusion water,” “xtnd your youth eye cream,” “BB cream with signature FLEXITONE®,” “Cellusculpt,” “Do Not Age with dr. brandt® triple peptide eye cream,” dr. brandt dark circles away®,” “pores no more pore refiner primer,” “pores no more poresolution,” “Do Not Age with dr. brandt beauty sleep serum,” “needles no more®,” “Do Not Age with dr. brandt® transforming pearl serum,” “Ultimate anti-aging solution,” “Laser Fx lift serum,” “Best of Brandt holiday kit,” “Do Not Age discovery kit,” “needles no more 3-D filler Mask,” “The doctor's VIP treatments,” “detoxifying anti-oxidant water booster goji-maqui).” As described below, your website promotes these products for conditions that cause the products to be drugs under the Federal Food, Drug, and Cosmetic Act (the Act). As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
 
Unapproved New Drugs
 
The following topical products are promoted for uses that cause the products to be drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and/or 201(g)(1)(C)]. The claims on your website indicate that these products are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Glow product line (overnight resurfacing serum, ruby crystal retinol hydracrème, revitalizing retinol eye cream, glow by dr. brandt® travel kit):
 
·       “[B]oosts collagen production…”
 
Shop by concern – dry skin (The Wrinkle Solution, Do Not Age with dr. brandt dream night cream, oxygen facial flash recovery mask, Save Our Skin, Do Not Age with dr. brandt ® time reversing cream 30g, Do Not Age with dr. brandt ® time reversing cream, Do Not Age with dr. brandt® firming neck cream, xtend your youth dual fusion water, xtnd your youth eye cream, and BB cream with signature FLEXITONE®, ultimate anti-aging solution 2.0, detoxifying anti-oxidant water booster goji-maqui):
 
·       “Seborrheic dermatitis can lead to dry patches, itchy skin, flaking and/or scaling”
 
Shop by concern – mature skin, deep wrinkles (The Wrinkle Solution, Do Not Age with dr. brandt beauty sleep serum, Do Not Age with dr. brandt dream night cream, needles no more®, oxygen facial flash recovery mask, Do Not Age with dr. brandt® transforming pearl serum, Ultimate anti-aging solution, Do Not Age with dr. brandt® triple peptide eye cream, Do Not Age with dr. brandt ® time reversing cream 30g, Laser Fx lift serum, Best of Brandt holiday kit, Do Not Age discovery kit, Do Not Age with dr. brandt ® time reversing cream, and Do Not Age with dr. brandt® firming neck cream, needles no more 3-D filler Mask, The doctor's VIP treatments):
 
·       “[A]dvanced collagen boosters and botox alternatives that actually work”
 
Cellusculpt:
 
·       “[H]elps breakdown fat deposits…”
 
Do Not Age with dr. brandt® triple peptide eye cream
 
·       “[R]epairs damaged skin”
 
xtend your youth dual fusion water
 
·       “[W]ill protect it from inflammation… and inhibit bacterial reactions”
 
Save Our Skin
 
·       “[A]n emergency solution for post laser, peeling or injections”
 
dr. brandt dark circles away®
 
·       “helps fade dark circles by stimulating microcirculation”
·       “reduces puffiness by draining excess fluids”
·       “helps reduce under eye bags by breaking down abnormal fatty deposits”
 
pores no more pore refiner primer
 
·       “[A]ntibacterial action”
 
pores no more poresolution
 
·       “[A]ntibacterial”
 
Your above-listed products are not generally recognized as safe and effective for the above-referenced uses and therefore, the products are “new drugs” under Section 201(p)(1) of the Act [21 USC § 321(p)(1)]. A new drug may not be legally marketed in the United States without prior approval from FDA as described in Section 505(a) of the Act [21 USC § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
 
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to promptly correct these violations may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
 
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA.  You may respond in writing to Andrea H. Norwood, Compliance Officer, Food & Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions about the contents of this letter, please contact CO Norwood at 407-475-4724.
 
Sincerely,
/s/ 
Susan M. Turcovski
Director, Florida District

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