Counterfeit Colgate: A Wake up Call for the FDA

The U.S. Food and Drug Administration aggressively regulates products such as food, veterinary products, cosmetics, and medical devices in order to advance and protect the public health. As a result of some of the lethal side effects of medications, the FDA has focused its attention on the safety standards of prescription drugs. Although the FDA has demonstrated adequate surveillance of pharmaceutical drugs, they have failed to sufficiently regulate nutraceuticals and other consumer products, like toothpaste. Recently, counterfeit “Colgate” toothpaste was found in discount stores in several states across the country. It was detected to contain a toxic chemical known as diethylene glycol (DEG), which is illegally used as an artificial sweetener, thickening agent or solvent, and is commonly found in antifreeze. Dr. Nestor Sosa M.D., shown to the right, is a University of Miami trained physician who discovered DEG in other consumer products like cough syrup. He claims that DEG may result in weakness and tingling in the legs, kidney failure, neurological degeneration, and possibly death. Unfortunately, it was only after customers experienced these harmful side effects that the FDA recognized the situation. Even after the toxic side effects were exposed, the FDA continued to take a passive role in regulation. Since the discovery, the company has only pulled the product from shelves in Massachusetts. It still remains in stores in Pennsylvania, New York, Maryland, Florida and New Jersey, and customers in other areas have only received a warning to stay away from the item. Douglas Arbesfeld, a spokesman for the FDA, seemed to take a nonchalant stance on the situation when he stated, “It's (DEG) a low health risk but the bottom line is, it doesn't belong in toothpaste.” It is irresponsible for Arbesfeld to minimize the significance of the side effects of [DEG], particularly after medical doctors from prestigious universities claim that the toxin may be extremely risky and unsafe.

Regulatory agencies, especially the FDA, should have taken a more active role in regulation prior to the public experiencing these toxic consequences. Perhaps their inability to do so may be because of the larger mood of deregulation in Washington. Medical device field inspection and enforcement programs took a 12.2% cut in the FDA’s 1998 budget, as James G. Dickenson claims. Lillian Gill suggested, “The cut would mean fewer and shorter inspections, new risk-based enforcement strategies, elimination of field-headquarters overlaps in processing product recalls, less travel, and more use of satellite- and videoconferencing to get her office's message out.” Nevertheless, the FDA failed to take action, as they overlooked the several misspelled words on the product carton. Other distinguishing characteristics of the imitation product include its origin. Colgate has never imported toothpaste from South Africa, and the FDA neglected to recognize the phrase “Manufactured in South Africa” within the labeling on the container. Fortunately, the Colgate-Palmolive company has made additional developments and taken action to protect consumers against possible risks from the counterfeit toothpaste. For instance, they have clarified to consumers how to distinctly identify the product, and are currently working with the American Dental Association and the American Dental Hygienists Association to provide information to dental professionals in hopes to assist them in answering patient questions. They have also ensured the public that their authentic product is safe by stating that, "Diethylene Glycol is not used in any Colgate toothpaste in the United States or anywhere else in the world and Colgate does not import toothpaste from South Africa into America." Furthermore, by supplying additional representatives on its consumer information line and extending their hours of operation, Colgate Palmolive has made itself more readily available to answer any questions about the counterfeit product.

It is disturbing that the only reason consumers are truly aware of the issues with the counterfeit Colgate is through the Colgate-Palmolive company itself (see toothpaste to left). The Federal Drug Administration is one of the largest regulatory entities in the world, and the public should be reassured that the company will not only meticulously inspect prescription drugs, but also carefully examine everyday household products. There have been recent claims that counterfeit toothpaste is not only being imported from South Africa, but from China as well. Although the FDA claims that, “All Chinese toothpaste is stopped and tested at the border, and very little, if any is coming into the United States,” it is difficult to believe such a statement following the issues with the counterfeit Colgate. The FDA should assure customers of their safety by assessing and evaluating over-the counter products of all origins, including other brands of toothpaste and dental hygienic products, which could potentially contain toxic substances. It should be a requirement for the FDA to examine items that are ingested and also topically applied, because topically applied products have significant systemic absorption.

Failure by the FDA to properly regulate certain materials may not only take a toll on consumers and patients, but could hurt dentists and physicians as well. Dr. Michael Pelekanos M.D. of Forbes Regional Hospital, a qualified obstetrician and gynecologist from the University of Pennsylvania said, “There’s less control on generic drugs. A patient who was on Dilantin for seizure activity for ten years promptly seized two days after starting the generic version. Fortunately the patient was home, but had she’d been driving, it could have jeopardized her life, passangers’ in other cars, and potentially cost me my job.” Inevitably, the system of policing consumer products will never be perfect, even with added regulation to non-prescriptions items. Toxicities of certain compounds may not manifest until repetitive use. However, taking a step towards making the inspection process better is what our governmental agencies must do.