Is the soap you use a drug, a cosmetic or both? Sometimes, the US Food and Drug Administration doesn’t even know. The legal difference between a cosmetic and a drug is determined by a product’s intended use. Different laws and regulation apply to each type of product.
The FDA defines cosmetics by their intended uses as “articles intended to be rubbed. Poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body for cleansing or otherwise applied to the human body…for cleaning, beautifying, promoting attractiveness or altering the appearance” (FD&C ACT sec. 201 (1). Shampoos and toothpastes are considered cosmetics
The FD &C Act defined a drug by its intended ended use to diagnose, cure, mitigate, treat, or prevent a disease. A drug , other than foods, is also intended to affect the structure, or any function of the body of humans or other animals (FD&C Act201)(g)(1)
Can a Product be both a cosmetic and a drug?
This is where things become complicated. A shampoo, for example, is a cosmetic because its intended use is to cleanse the hair as an anti-dandruff treatment; it is a drug because it is intended to treat dandruff. Another example is toothpaste that contains fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection chemical.
FDA does not have a premarket approval system for cosmetic products ingredients with the exception of color additives; also cannot remove a cosmetic from the market unless a consumer or health practitoners makes a complaint and files it with the FDA. Cosmetics, in other words, usually unregulated and anyone can go into the business using their own kitchen to make the product.
Drugs, on the other and, are asked to have premarket approval by the FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. There are more than more loopholes in this “safe guard”. I wrote a whole book about it, A Consumer’s Dictionary of Cosmetic Ingredients.
It is becoming more and more difficult today to determine a drug from a cosmetic. Almost all drug, food and cosmetic ingredients are made overseas. The FDA is underfunded and understaffed. Complete.
How to clean up the mess?
Take triclosan, an antimicrobial, and antibacterial found in soaps. Several studies have shown that triclosan may alter hormone regulation in laboratory animals or cause antibiotic resistance. Some consumer groups and members of Congress want triclosan banned in antiseptic products such as hand soap. The F.D.A. has already said that soap with triclosan is no more effective than washing with ordinary soap and water, a finding that manufacturers dispute.
The F.D.A. was to announce the results of its review of triclosan this year, but now says the report is unlikely until next year. The Environmental Protection Agency is also looking into the safety of triclosan.
In August, 10, 2011, ten law suits in various states against the marketing materials for Dial Complete, — which contains triclosan, — were consolidated in a New Hampshire Federal court. The suits are based on the claims the product “kills 99.99% of germs” and “kills more germs than any other liquid hand soap” The pending lawsuits maintain these claims are false and misleading.
The outcome of the federal inquiries poses a significant risk to the makers of antimicrobial and antibacterial hand soaps, which represent about half of the $750 million market for liquid hand soaps in the United States, according to the market research firm Kline & Company.
Many of those soaps use triclosan as the active ingredient and say so on the label. Dial Complete is the fifth-best-selling liquid hand soap in the nation, according to data collected from most major stores (except for Wal-Mart) by Symphony IRI Group, a Chicago-based market research firm.
Richard Theiler, senior vice president for research and development at Henkel, the German-based manufacturer of Dial Complete, says there was no real evidence showing that triclosan is dangerous for humans. He also says several recent studies had proved the effectiveness of triclosan in killing germs, and that those studies had been submitted to the federal regulators.
But as consumer groups have campaigned against triclosan, some consumer product manufacturers have removed it and substituted less controversial ingredients. Reckitt Benckiser removed triclosan from three face washes, for instance. And citing “changing consumer preferences,” Colgate-Palmolive replaced triclosan with lactic acid, a product derived from glucose and glycogen (sugar and alcohol). It is produced commercially by fermentation of whey, cornstarch, potatoes, and molasses. In Palmolive Antibacterial Dish Liquid, and its Soft soap liquid hand soap has been reformulated without triclosan.
Colgate, however, continues to use triclosan in its Colgate Total Toothpaste because it has been proven to fight gum inflammation, a claim approved by the F.D.A.
“The safety and efficacy of Colgate Total toothpaste is fully supported by over 70 clinical studies in over 10,000 patients,” the company said in a statement. Never-the-less, scientists have raised concerns about triclosan for decades. Last year, Representative Edward J. Markey, (D-MA) pressured the F.D.A. to write regulations for antiseptic products like hand soap, including the use of triclosan. Although the process of creating regulations was started more than three decades ago, Mr. Markey has called now for a ban on triclosan in hand soaps, in products that come in contact with food and in products marketed to children.
The concern is based on recent studies about the possible health impacts of triclosan, which the F.D.A. said, in a Feb. 23, 2010, in a letter to Mr. Markey that recent studies “raise valid concerns about the effect of repetitive daily human exposure to these antiseptic ingredients.”
So what is a soap of a drug?
The FDA’s Code of Regulations concluded in 2010:
If a product:
- Is intended solely for cleansing the human body and
- Has the characteristics consumers generally associate with soap
- Does not consist primarily of alkali a salt of fatty acids (pH greater than 7) it may be identified in labeling as soap, but it is regulated as a cosmetic.”