Client Health

What Does FDA Say?

The FDA receives relatively few cosmetic-relatd consumer complaints; manufacturers aren't required to pass along complaints they receive. 

Editor’s Note: The following article by Annabel Hecht is reprinted from the February 1988 issue of FDA Consumer, the official magazine of the U.S. Food and Drug Administration. We would like to thank Mr. John A. Wenninger, FDA Division of Colors and Cosmetics for keeping us informed and for allowing us to reprint the story.

The art teacher’s nails were, admittedly, in bad shape. The materials she used in her classes—clay, finger paints, India ink—plus the constant hand washing to get them off had made her nails split and break. Usually she just lived with it, but the following week she was getting married and naturally wanted her nails to look their best. Thanks to a procedure that has become increasingly popular coast to coast, she was able to do that with little trouble. She had new nails sculptured over the old.

Today, modern acrylics and other plastic materials make it possible to “grow” a whole new set of nails in a matter of minutes or to have perfect nails to mask those that are broken, chewed to the quick, or just not as long as you would like. Some of these artificial nails can be had only at beauty salons or at ultra-specialized nail salons; others are do-it-yourself. But, whatever the type, it’s important to know that these products are not without risk. Used improperly, they can cause infections, allergic reactions, and other problems. So care in creating and tending your new nails will help make sure the attention they bring you isn’t just from your dermatologist.

To create the art teacher’s new nails, the nail salon technician first buffed each nail to remove natural oils and slightly roughen the surface so the acrylic material would adhere. Then she applied an antiseptic as a precaution against infection. Finally, to support the sculptured extension and to protect the surrounding skin, she fitted a small horseshoe-shaped collar made of foil with a mylar coating around each nail.

Using a vibrating brush first dipped in a clear liquid, then in a powder, the technician placed a bead of the resulting material on the nail. The vibrations of the brush helped blend the material and spread it evenly over the nail. Additional material was added to build and extend the new nail. The technician had to work quickly because the acrylic material hardens fast, and in less than half an hour the teacher’s new nails were finished, ready to be further shaped and polished.

That’s not quite the end of the process, however. The sculptured nail will move up as the nail grows, leaving a space at the cuticle end of the nail. In order to maintain her new nails the art teacher will have to return every two or three weeks for a “fill-in.” Once applied, the artificial nails can stay on for years. However, Dr. Richard Sher, a dermatologist and expert on nails formerly with Brown University in Rhode Island, says he advises his patients to remove the acrylic at least once a year to give the nails a rest.

Techniques used to apply sculptured nails may vary from salon to salon, but the materials used are basically the same and are, incidentally, from the same class of chemicals as those used to make dentures—the pink-colored base that holds the false teeth, not the teeth themselves. (When used in dentistry these chemicals are regulated as medical devises by FDA. However, the agency does not have authority to require approval of these same chemicals for use in cosmetics.)

The powder is usually polymethyl methacrylate with benzoyl peroxide added as a catalyst; the liquid is a mixture of one or more methacrylate ester monomers and promoter such as N, N-dimethyl-p-toluidine. When combined, the chemicals react so that the monomer (a simple molecule) becomes a polymer—a compound made up of two or more monomers. This is called polymerization.

Some nail-building products are gels that usually contain methacrylic or acrylic ester monomers, polyurethane, and a curing agent all in one. They are painted on the nails in much the same way as the two part process, but are then “cured”, or hardened, under visible or ultraviolet light or by an activator in the form of a spray.

Longer nails can also be created by attaching plastic tips to the natural nail with a special acrylic glue. About one-fourth to one-half of the nail will be covered, depending on the design of the tip. In the case of nail biters, who have less to start with, the tip may cover a good part of the nail. Acrylic nail builders and nail wrappings may be applied over the tip and the nail to strengthen the bond between the two.

Nail wraps also may be used alone to strengthen and repair natural nails without artificial tips. The wraps, which are made of paper, silk, linen, fibreglass, or—for those with exotic tastes—reptile skins, are applied with nail glue or sealers, and can be filed or polished. Like the sculptured nails, nail tips and wraps move up as the nails grow, necessitating return visits for fill-ins and fix-ups.

What must be the ultimate in artificial finger adornment is the 14-karat gold nail. Often sold in jewelry stores, gold nails are available plain or set with diamonds and are applied in the same way as plastic nails.

For the consumer who wants longer nails but can’t afford salon prices (a new set of nails may run $50 or more), satisfaction is as close as the nearest drugstore.

Most stores carry a selection of do-it-yourself nail extenders. For those who want sculptured nails there is a kit containing the acrylic liquid and powder, nail forms, and brushes similar to those used in nail salons. Also available are the preformed plastic tips and full nails that can be had in “natural,” “European,” “glamour” or “Dragon Lady” lengths. Plastic nails are either glued on with an acrylic substance or pressed on using a patch with adhesive on both sides. Some of the plastic nails come already colored; others are clear or white and can be polished like a natural nail.

While all of these products—from store or salon—can pose some hazards, today’s materials are not likely to cause problems as did those used when artificial nails first became available. In the early 1970’s, FDA received complaints of discoloration, deformity or loss of fingernails, and irritation and inflammation of the nail bed or nail fold at the base of the nail from women who had used nail-building kits containing methyl methacrylate.

FDA subsequently sued C.E.B. Products, Inc., the manufacturer of a methyl methacrylate monomer containing nail product called Long Nails, for distributing an adulterated cosmetic in interstate commerce. Distribution of Long Nails was halted under a court order. This action, and the seizure and recall of other similar products during the second half of 1974 and in 1975, led manufacturers to reformulate their products. Methyl methacrylate was replaced by other methacrylate esters such as ethyl methacrylate, isobutyl methacrylate, and many other chemically realted monomers.

Reformulation, however, did not completely eliminate problems with artificial nails. From 1976 to 1986, FDA received 65 consumer complaints about nail-building products, including nail damage, skin reactions, infections, headaches, sneezing, nausea and coughing. This does not represent all of the adverse reactions that may have occurred during this period, however. FDA receives relatively few cosmetic-related consumer complaints and manufacturers are not required to pass along any complaints they receive.

Some people who are sensitive to acrylics have had allergic reactions to sculptured nails. The chemicals may cause redness, swelling and pain in the nail bed and the surrounding tissue. Heinz Eiermann, director of the division of colors and cosmetics in FDA’s Center for Food Safety and Applied Nutrition, says these reactions may occur when the methacrylate monomers are not completely cured, or polymerized, leaving some monomer free to enter the natural nail. In some cases, it may be imperfect if the nail root has been damaged.

Once a person becomes allergic to acrylics—which can happen after repeated exposure to them—she (or he) may never be able to use the products again. (For more on sensitization, see “Cosmetic Allergies” in the November 1986 FDA Consumer.) But allergic reactions to acrylic nails are infrequent, Eiermann says. Of greater concern, perhaps, are bacterial or fungal infections that develop on top of the natural nail between it and the artificial nail.

A bump or knock to a long artificial nail may cause it to lift from the natural nail at the base, leaving an opening for dirt to get in. If the nail is reglued without proper cleaning, bacterial or fungal spores may grow between the nails and possibly spread into the natural nail.

The primary symptom of a fungal infection is blue-green discoloration of the nail—an indication that the fungus has grown into the nail plate. In mild cases there is no pain. When discoloration is noticed, all artificial coloring must be removed before the infected areas can be treated with an antimicrobial product. Unfortunately, the discoloration will remain four to six months until the nails have grown out. Severe, painful cases of infection, should be treated by a dermatologist.

The press-on and glue-on, do-it-yourself plastic nails pose few hazards if used according to the package directions. But if care isn’t taken, glue can bond to the skin or irritate the eye. Some products warn that their adhesives are flammable and should be used in a well ventilated area. The plastic nails themselves should be kept away from heat and flames. Full-sized nails should be removed after 48 hours, in part because these nails do not always fit tightly over the natural nail, allowing space for microbial contamination.

Besides the instructions, the artificial nail package includes another very important item—the ingredient list. Unlike drugs, cosmetics—including artificial fingernails—do not have to be approved for safety and effectiveness by FDA before they go on the market, says John Wenninger, associate director for cosmetics of FDA’s colors and cosmetics division. But the law does require manufacturers to tell what’s in cosmetics, sold for use at home. (Ingredient labelling is not required on products sold solely for use in nail and beauty salons.) Ingredient information can be very helpful in alerting consumers to chemicals that could cause allergic reactions or other problems, says Wenninger. And if a problem requiring medical attention should develop, the physician will be aided by knowing what chemicals the patient was exposed to.

FDA continues to monitor consumer complaints of adverse reactions to all types of artificial nails and will take appropriate regulatory action against products that pose a health hazard. Agency laboratories are also analyzing nail products used in beauty and nail salons to get a better understanding of what chemicals are in them. The law does not require cosmetic products to be registered with FDA, although some firms do register their formulas voluntarily. However, very few, if any, nail extender products used in salons are registered.

Here are some things consumers should bear in mind if they intend to use artificial nails:

  • If there is any question about sensitivity to the materials in sculptured nails, have one nail done as a test and wait a few days to see if any reaction develops.
  • Never apply an artificial nail if the nail or tissue around it is infected or irritated; let the infection heal first.
  • Read instructions for do-it-yourself nails before applying them, and follow the directions carefully. Save the ingredient list for your doctor in case of an allergic reaction or other injury.
  • Treat your artificial nails with care. They may look—and be—stronger than your own, but they can still break and separate. Protect them from harsh detergents and microbial contamination. Try not to bump or knock the tips. Find new ways to do ordinary tasks, like using a pencil to dial the phone.
  • If an artificial nail separates, dip the fingertip into rubbing alcohol to clean the space between the natural and artificial nails before reattaching the artificial nail. This will help prevent infection. Never use household glues for home repairs. Use only products intended for such use, and follow the instructions and heed all cautions on the product label.

Annabel Hecht is a free-lance writer in Silver Spring, Maryland, specializing in health reporting.

Facebook Comments ()

Leave a Comment


Comments (0)

Subscribe to NAILS & SAVE!

Get a free preview issue and a Free Gift
Subscribe Today!

Please sign in or register to .    Close
Subscribe Today
Subscribe Today