Pat McCarthy
Owner of Piercology

“Approved by the FDA” is a claim we’ve all seen on corporate websites or mentioned in marketing literature and online ads. Salespeople sometimes refer to the products they promote within the body art community as being “FDA approved”. Clients who come to Piercology often ask me or my piercing staff if the US Food and Drug Administration (FDA) has approved the products we use. I’m sure many of you have faced similar questions or simply wondered yourselves.

I’ve done some research in order to clarify the issue and answer in a fair and honest way the following questions. Does a manufacturer or distributor have the legitimate right to claim a particular product was approved by the FDA? If the product has an Over-the-Counter (OTC) drug label and a National Drug Code (NDC) number what does that really mean?

This is what I’ve discovered:

The classification of cosmetics and drugs are defined by law, based on their intended use. Each classification has associated laws and regulations. There is a lot of information available, so let’s start with a few excerpts directly from the FDA website:

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.

The FD&C Act defines drugs…as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. Drugs, however, must generally either receive pre-market approval by FDA through the New Drug Application (NDA) process or they must conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded…(and) state requirements for categories of nonprescription drugs, such as what ingredients may be used and for what intended use.

In other words, the FDA does not approve cosmetic products or formulas. It is essentially left up to a manufacturer to insure their product complies with the standards, packaging, and label requirements. We all want to think “natural”, “botanical”, and “herbal” formulas are safer and better in some way. Maybe they are, but I remain skeptical until I know where the ingredients come from and if they have certificates of authenticity. I want answers to questions such as where was the formula developed and manufactured, is there a scientifically based and tested preservative system to prevent bacterial growth, is there stability testing, and has the product been tested against the type of bacterial concerns we face in our professional lives such as Staph, E.coli and MRSA? I’ve often wondered how some non-OTC products on the market have “healing claims” yet despite their intended use they are not registered as an OTC drug with an NDC number?

Contrary to what some people hope or believe, the FDA does not have a system in place to approve the vast majority of non-prescription OTC drug products intended for human use either. It is up to the manufacturer to insure their product(s) follow the existing monographs and prove their products are both safe and effective. At first glance it seems as if the government is relying on an “honor” system they believe responsible companies will follow.

Unfortunately, the result of leaving it up to others is that some claims seem “too good to be true”. Is it possible for example that a single product can be effective as a “skin prep” and gentle enough for “aftercare”? The concept of “electrified water” seems promising, but if sealed packaging is required to prevent a reduction in efficacy how do we know if the product works as promised after it’s opened, or after a few weeks or months. Critical questions should be asked regarding how a product is manufactured and if the prevailing monographs are being followed. Also important to question: how has the product been tested and where can the test results be found?

The FDA issues “Establishment Licenses” to manufacturing facilities that comply with rigorous standards that include “Current Good Manufacturing Practices” (cGMP) so it is important to know where the products we use and recommend come from. Topical antiseptics for example should be manufactured following cGMP regulations to insure the facility has appropriate procedures in place to prevent the presence of objectionable microorganisms in drug products that are not manufactured as sterile. A licensed facility typically has the staff, equipment and procedures in place to validate the raw materials, formulas and every stage of the production process.

Incredibly, there are documented cases of companies using “NDC-like” numbers on their labels without ever applying for or obtaining the legitimate NDC. Typically however, the vast majority of companies file an application to obtain the NDC prior to offering the product for sale to the public. Does this mean all OTC drug formulas are approved in advance? NO! Does it mean the FDA has approved the product because an NDC number has been assigned? NO! Obtaining an NDC number means the manufacturer has provided the required information and followed the correct steps during the application process. This includes stating the intended use of the product and confirming the active and inactive ingredients are not restricted or used in amounts beyond the established limits. Also, the OTC drug label structure and claims must all fall within the prevailing FDA monograph.

A section of the FDA website supplies a frequently updated NDC directory, which clearly states: “Assignment of an NDC number does not in any way denote FDA approval of the product. Any representation that creates an impression of official approval because of possession of an NDC number is misleading and constitutes misbranding. (21 CFR 207.39)”

So why do some companies claim their products have been “FDA approved” when in fact it’s not an accurate statement? Do they think we are easily fooled? Maybe…

The FDA website explains the drug application of OTC classified products, which states: “OTC drugs are defined as drugs that are safe and effective for use by the general public without seeking treatment by a health professional. Because there are over 300,000 marketed OTC drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs. OTC drug monographs are a kind of “recipe book” covering acceptable ingredients, doses, formulations, and labeling. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients.”

DailyMed is a website operated by the US National Library of Medicine (NLM) to publish up-to-date and accurate drug labels to health care providers and the general public. The contents are provided and updated daily by the FDA. As a handy reference source that lists individual OTC drugs that have been assigned an NDC number, it is important to know the information provided usually comes with this disclaimer: “Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.”

The bottom line is this, don’t be fooled by marketing claims that a particular product has been “approved” by any government agency, including the FDA. My best advice is to look up the NDC number on a site like DailyMed, find out the origin of the product, and ask the manufacturer or distributor for documented test results from a recognized and trusted lab to substantiate their claims of safety and efficacy. It always pays to ask questions, for your sake and for the sake of your clients.

Many products used in our industry may be well intentioned, including those meant for aftercare, but it’s important to know if the manufacturer follows aseptic cGMP techniques and the FDA monograph rules that cover acceptable ingredients, doses, formulations, and labeling of an OTC drug product. “Natural” does not automatically mean it’s better, safer, or more effective. Ask to see bona fide test results.

I’ve seen enough in my 22+ years in this business to know it’s OK to be skeptical. It’s OK to question what you do as a professional and strive to be the best you can be. It just makes good sense to protect yourself and your clients in order to grow your business. Because your friend or another artist uses a product does not prove anything! Before you choose to work with any product, or recommend it for your clients, find out where it comes from, and what testing has been done to prove it is both safe and effective for the intended purpose. Good luck and may your business grow and prosper in the future.

Some background: Pat is the owner of Piercology in Columbus, OH, one of the oldest and most successful piercing studios in the USA. He was the first elected President of the Association of Professional Piercers. He is the founding and current President of the Association of Body Art Professionals in Ohio. Pat has been working with Ohio legislators on body mod studio regulations, and he frequently lectures Ohio Health Inspectors on bloodborne pathogens and best practices in piercing and tattoo studios.