FDA Warns Cosmetic Companies About Unproven Claims

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Are you still convinced that a cosmetic can whisk away your wrinkles?

In 2013, I wrote: “As I have been reporting through seven editions of my Consumer’s Dictionary of Cosmetic Ingredients, the definition of cosmetic, according to the Food, Drug and Cosmetic Act, is that a cosmetic improves appearance, whereas a drug diagnoses, relieves or cures a disease.

Drugs are subjected to an intensive review and approval process by the FDA while cosmetics are not. Drugs also have to reveal side-effects and cosmetics do not.

If a cosmetic claims it can really make your skin younger, than it is a drug. If it can’t, then it is a false claim .

Warning!

The US Food and Drug Association (FDA) have sent out “warning letters” to certain companies about anti-aging claims. Examples of The FDA targeted cosmetic companies:

StriVectin was warned the claim their anti-aging product: “clinically proven to change the anatomy of a wrinkles” and “this superb age-fighting serum is super charged with…potent elastin stimulating peptides”. Its number one selling “Advanced Tightening Neck Cream “Features breakthrough Gravitite-CF Lifting Complex to restore the elastin fiber architecture providing noticeable lift and improving  resistance to gravity.

When I was pregnant—a long time ago—I remember StriVecting being promoted as a treatment for stretch marks… It is still promoted today for that but includes:

“StriVectin SD is a hydrating moisturizer which targets Collagen III, also known as ‘youth collagen’. Youth collagen is vital for smooth and soft skin, and thus its revitalization will prevent wrinkles and stretch marks from forming”

According to the manufacturer – Klein-Becker, StriVectin SD stimulates collagen production and helps repair the damaged skin cells that cause stretch marks. The company also claims that the hydrating formula of the product can help improve the skin’s texture and tone and dramatically change the look of your skin.

The FDA says “appearance” or “look”: are OK but “collagen production” and “repair damaged skin” are not.

L’Oréal USA, which has a lot of money, also received a warning letter this year from the FDA saying “based on a review your products “Rosalie AR Intense” and “Meta D Pigment Control” claims on the website indicate they 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…”

Rosaliac AR Intense is “recommended for Redness-prone skin, experiencing overall redness, flushing and sensation of discomfort….Formula combines 3 effective ingredients to help reduce redness with a long lasting efficacy”

Mela-D Pigment Control—now renamed Youth Code Dark Spot Correcting & Illuminating Serum Corrector  is claimed to  help fade the appearance of dark spots, age spots, sun damage and post acne marks that can make skin appear up to 10 years older. Restore luminosity and fight discoloration with Youth Code Dark Spot Correcting & Illuminating Serum Corrector. This clinically proven formula illuminates skin tone and improves the appearance of dark spots for a more even, radiant and youthful complexion. 86% of women saw fewer dark spots in just 8 weeks*.

The Paris division of L’oreal can obviously ignore the FDA claim restrictions: Its product, Repair Wrinkles. Refirm Contours. Redensify Skin.is claimed to be :

“Formulated with Pro-Xylane + Hyaluronic Acid. Which can  “Visibly reduce wrinkles in 4 weeks.”

Avon Products, Inc. (U.S. Headquarters) 

This WARNING LETTER was sent to AVON’s NY Headquarters Oct 5.2012 and y re-sent Feb.  2015:

This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address http://www.avon.com in August 2012. Based on this review, your products Anew Clinical Advanced Wrinkle Corrector, Anew Reversalist Night Renewal Cream, Anew Reversalist Renewal Serum, Anew Clinical Thermafirm Face Lifting Cream, and Solutions Liquid Bra Toning Gel appear to be intended for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)]. The claims on your web site indicate that these products are intended to affect the structure or any function of the human body, rendering them drugs under the Act. The marketing of these products with claims evidencing these intended uses violates the Act.

The FDA cited examples of some of the red flag claims observed on Avon’s website site include:

Anew Reversalist Night Renewal Cream & Anew Reversalist Renewal Serum

Avon explains “Wrinkles are a result of micro-injuries to the skin, so AVON studied how skin heals. As part of the repair process, the body produces activin…exhaustive research, testing & review have resulted in an unprecedented discovery by AVON scientists: how to activate this key repair molecule. . . . Designed to boost Activin, ANEW’s Activinol Technology helps reactivate skin’s repair process to recreate fresh skin & help dramatically reverse visible wrinkles.”

Anew Clinical Thermafirm Face Lifting Cream

“Our effective lifting treatment is formulated to fortify damaged tissue with new collagen. In just 3 days, see tighter, firmer, more lifted skin.”help tighten the connections between skin’s layers.”

Solutions Liquid Bra Toning Gel

“Formulated with pomegranate and fennel extracts to help boost production of collagen and elastin.”

The FDA’s  letter says: “Your products are not generally recognized among qualified experts as safe and effective for the above referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)],  a new drug may not be legally marketed in the U.S. without prior approval from FDA in the form of an approved New Drug Application (NDA). A description of the new drug approval process can be found on FDA’s  website at:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993

When I accessed the site July 10 2015, the product  is called  Dramatic Firming Cream

Its ingredients are listed as: WATER/EAU MYRISTYL MYRISTATE PRUNUS ARMENIACA (APRICOT) KERNEL OIL BUTYLENE GLYCOL GLYCERYL STEARATE HYDROGENATED VEGETABLE GLYCERIDES PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE SQUALANE PUNICA GRANATUM FRUIT JUICE DAUCUS CAROTA SATIVA (CARROT) SEED OIL RETINYL PALMITATE TOCOPHEROL SOLUBLE COLLAGEN CETEARYL ALCOHOL PEG-100 STEARATE XANTHAN GUM TRIETHANOLAMINE CARBOMER CHOLETH-24 METHYLPARABEN IMIDAZOLIDINYL UREA DIMETHICONE SORBITAN STEARATE CETETH-24 GLYCOL STEARATE ISODECYL SALICYLATE POLYSORBATE 60 PARFUM/FRAGRANCE PEG-150 STEARATE STEARETH-20 STEARAMIDE AMP

In A Consumer’s Dictionary of Cosmetic Ingredients you will note the cream includes grapefruit juice, Carrot seed oil, a number of synthetic oils and fragrance.

Do you think the name on the jar “Dramatic Firming Agent” claims  a body altering ingredient?

And another concern— labeling on a cosmetic container is supposed to have the information about the product large enough so it can be readable for most people. The (Principal Display Panel (PDP) is that part of the label that is most likely to be shown or examined under customary conditions for retail sale. Regulations [21 CFR 701.10] published by the FDA require that the PDP be large enough to accommodate all required label information with clarity and conspicuousness. Exceptions are: Decorative containers; compacts or pencils; container of ¼ ad/oz. or 1/8 fl.oz.capacity and also display cards’lipstick2

I just made an appointment with my ophthalmologist because I couldn’t read the information on the cosmetic  jars I was checking with my glasses plus a magnifying glass.

What effect will the warning letters from the FDA have? The FDA is a paper tiger. Some of the large companies will probably make changes for the benefit of educated consumers. If the FDA takes cosmetic companies to court, it would cost millions of citizen dollars, The Agency will usually lose because the manufacturers have more millions and better lobbyists to fight the charges.

In the meantime, cosmetic sales of anti-aging products are skyrocketing because we are convinced wrinkles and sagging chins make us undesirable to potential friends , employers and to ourselves.

There are more than two dozen warning letters sent out recently by the FDA to cosmetic companies—big and small– Check for yourself: http://www.fda.gov/Cosmetics/ComplianceEnforcement/WarningLetters/ucm081086.htm

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