The Science of Nails

What Do EPA Registration and FDA Approval Really Mean?

The EPA and FDA play important roles in monitoring chemical use in the United States, but they may not offer as much protection as you think.

True or false? “EPA-registered” means a product should do what the label says and should not pose an unreasonable hazard to your health.

True or false? “FDA-approved” means the product has been tested and deemed safe for consumer use by the Food and Drug Administration.

True or false? “EPA-registered” tells you the product is environmentally friendly.

Answers: True. False. False.

“EPA-registered” and “FDA-approved” are terms that sound official and reassuring but that may not mean what you think.

Some people interpret these pronouncements as meaning that the product is endorsed or deemed safe by these government agencies. This is not true, say the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA).

To understand what roles these two government agencies have in approving products before they’re allowed on the market, NAILS talked to representatives from the EPA and the FDA Color and Cosmetics Division and Office of Over-The Counter Drug Evaluation. Each agency explained its function, how it gathers scientific data and product information, and what registration or approval means to you, the nail technician.

EPA REGISTRATION

Salon disinfectants for use on implements, workstations, and other salon surfaces are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of 1947. The act was amended in 1988, giving the EPA even more authority to regulate pesticides.

FIFRA sets the standards for pesticide registration (salon disinfectants are classified as pesticides by the EPA). According to the EPA Highlights of the 1988 Pesticide Law pamphlet, pesticides are required to perform their intended function when used according to manufacturer’s directions, without posing “unreasonable risks of adverse effects on human health or the environment.”

To register a product with the EPA, there are several steps a company must follow. If, for example, ABC Disinfectant Company formulates a salon disinfectant with bactericidal, fungicidal, and virucidal activity, it must submit a statement detailing the product formula, the proposed product label, and data on the active ingredient (the ingredient that does the work) and inert ingredients (ingredients that keep the formula liquid, add color and fragrance, etc.).

If ABC’s product contains a completely new active ingredient that hasn’t been used as an EPA-registered disinfectant before, the company must submit research data that shows the product doesn’t pose an “unreasonable risk of adverse effects.”

Specifically, the EPA is concerned with the acute (short-term) and chronic (long-term) effects of the active ingredient on human health as well as its impact on the environment. The claims must be supported by the data.

On the other hand, if ABC using an active ingredient that has been used in other EPA-registered disinfectants and the active ingredients has been already registered with the EPA, ABC can get permission from the company that did the original studies to use its data. This can greatly reduce the cost and time for ABC to register its product.

Once the active ingredient is approved, ABC provides specific data on its product – the chemistry of the formulation, how the product performs, and its acute toxicity (immediate health effects). Companies are required to provide a product’s complete formulation. Although manufacturers aren’t required to list every ingredient on the MSDS and product labels that a consumer will ultimately see, they must reveal all to the EPA.

If the product and use directions are substantially similar to another EPA-registered product, the EPA is supposed to approve or deny registration within 90 days. If the active ingredient is new or if its use is new, the registration process can take years.

WHAT DOES IT MEAN?

Once ABC has provided all the required information, filled out various forms, and has finally received an EPA registration number, the company prints the number on the product label. The EPA registration number tells you that the product has demonstrated that it should not cause unreasonable adverse effects on your health or the environment when used according to label instructions.

Adds Wallace Powell, a product reviewer for the EPA Antimicrobial Program, the registration number also tells you that, when used as directed on the label, the product should do what it claims. So, if you purchase ABC’s EPA-registered disinfectant that says it has bacterial, fungicidal, and virucidal activity, you know it should kill bacteria, fungi, and viruses.

“If it’s a so-called human health related product, then the EPA supports those claims of fungicidal, virucidal, etc.,” says Powell. Product effectiveness also is implied by EPA registration. “If it doesn’t work well then it poses a hazard to people because they are depending on it to work in a health-related sense,” continues Powell.

The EPA does not, however, support or approve phrases such as environmentally friendly, non-toxic, organic, or safe.

“Phrases like that are considered misleading because they’re not quantifiable,” explains Powell. “They may give the impression of a degree of safety that is not true.” In general, the EPA does not allow claims like those to be made on the product’s label.

FDA and COSMETICS

The primary responsibility of the FDA is to enforce the regulations and requirements of the Food, Drug and Cosmetics Act of 1938, which protects consumers from contaminated or misbranded (mislabeled) products. There is a common misconception, however, that this means the FDA tests and approves cosmetic ingredients and products, which is not unreasonable considering all the well-publicized flak the FDA gets when if refuses to approve a drug.

However, with cosmetics, unlike with drugs, manufacturers do not have to submit any information to the FDA, and cosmetics are not subject to registration or approval before they are marketed. The FDA Cosmetic Handbook defines cosmetics as “articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or function.” Most nail care products fall into this category.

With the exception of color additives and a few prohibited ingredients, a manufacturing may formulate a product using almost any raw material and sell it as a cosmetic without approval from the FDA, says Dr. John Bailey, acting director of the FDA Color and Cosmetics Division. In general, color additives must be approved by the FDA before they are used.

Though the FDA doesn’t generally regulate product formulations or ingredients like the EPA does, the FD&C Act prohibits the distribution of cosmetics that are impure or misbranded.

A product is considered impure if it contains a substance that makes it harmful to consumers under customary conditions of use; if it contains a “filthy, putrid, or decomposed” substance; if the container is made of a harmful substance; if it’s manufactured or stored under unsanitary conditions; or if it contains a non-approved color additive.

Misbranded products are defined as having false or misleading information, insufficient information, or the incorrect net weight on the label. Cosmetics intended for retail sale to consumers for personal use must have ingredients listed conspicuously and in descending order. Products intended for professional-use only are not required to have ingredients listed.

Complaints from consumers about cosmetic products are evaluated on a case-by-case basis, says Bailey. Although the FDA prohibits false or misleading information, a manufacturer doesn’t have to prove the product does what it claims or even that it won’t hurt someone. “You can’t make wildly exaggerated claims or say anything beyond what’s accepted boundaries for puffery,” says Bailey. However, he adds, the rules change if the cosmetic makes claims that it has curative or medicinal properties, claims would define it as a drug.

COSMETIC OR DRUG?

“If it claims to affect the structure and function of the body then you’re into another regulatory scheme,” explains Bailey. “Those are considered OTC drug products. A product that is an antifungal has to be in compliance with the OTC drug monograph.” The OTC drug monograph is a set of regulations governing the sale of non prescription drugs. Any cosmetic that claims to prevent, treat, or cure a condition is classified as a drug, he adds.

FDA regulations for drugs are much more stringent. Any prescription or over-the-counter drug manufacturer, repacker, or distributor must register with the FDA each year and update its list of all manufactured drugs twice a year. Regulation of OTC drugs (drugs sold without a prescription), however, is much less stringent than prescription drugs.

While manufacturers must register their product to sell it, that does not mean the drug is approved by the FDA or that it is safe and effective, explains Debbie Lumpkins, a microbiologist with the FDA Office of OTC Drug Evaluation.

Nail treatments containing antifungals for example must be registered with the Office of OTC Drug Evaluation. Products currently do not have to be approved by the FDA, but new regulations are in the works, says Lumpkins.

“Manufacturer X can have an antifungal nail product on the market now even though it hasn’t been determined to be safe and productive,” says Lumpkins. If the current proposed rules are finalized, she says antifungal nail treatment manufacturers will have several options: reformulate their product, apply for a New Drug Application (NDA), or submit a citizen’s petition.

FDA IN ACTION

Although the FD&C Act limits the FDA’s power until a product is distributed or sold, the FDA doesn’t just turn a blind eye until major problems arise.

According to Bailey, the FDA records and tracks complaints about products. “We have a voluntary registration program where companies can register their establishments and report adverse reactions they know of,” he says. These companies are given an FDA registration number, but Bailey emphasizes that this does not give FDA approval, clearance, sanction, or endorsement to any company or product.

And, although the FDA does not require that cosmetic products be tested for safety, the FDA strongly urges cosmetics manufacturers to conduct whatever toxicological or other tests deemed appropriate to ensure the product’s safety. If you have any questions or doubts about a particular product, you should ask the manufacturer for information about what safety tests were performed and the results.

If a product causes injury says Bailey, the FDA then has legal authority to act. “If, for example, we all of a sudden get complaints that a product is causing burning, we can declare the product adulterated and stop its sale. And, if we find an ingredient cannot be used safely under all conditions of use, then we can prohibit it,” says Bailey. For example, the FDA received many complaints about methyl methacrylate (used in acrylic powders) in the 1970s. After an investigation, the FDA placed an injunction against its use in nail products.

If the FDA wants to prohibit an ingredient, it has to publish a prohibition proposal for that ingredient in the Federal Register, detailing why the FDA thinks it should not be used. Companies have time to comment and object in writing. The FDA reviews the new information and can declare a prohibition or drop the matter. If the companies still object they can go through the legal process to bar a prohibition. In the case of methyl methacrylate, the FDA didn’t publish a rule prohibiting its use, but, says Bailey, the FDA is ready to do so if necessary.

The FDA will monitor complaints and investigate a product when the complaints seem symptomatic of a problem. “If an injury is serious, one complaint may be all it takes. If reactions are less severe – allergic reactions, for example – we monitor the complaints and will investigate if there is a pattern,” says Bailey.

The EPA and FDA play important roles in monitoring chemical use in the United States. Your newly gained understanding of what the EPA and FDA do will help you evaluate product claims and know what protection you can, and can’t, depend on the government for when working with disinfectants, nail products, and other chemicals in the salon.

Keywords:   EPA     ingredients  



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