Many consumers shopping for health and beauty products believe they are buying a tested, effective product when they see the words “FDA approved” or “FDA registered.” In truth, however, outside the context of actual prescription medications and some medical devices used by physicians themselves, these words often have very little meaning. Our personal injury lawyers urge consumers to educate themselves about these terms, and use caution when buying.
In fact, manufacturers and sellers know that consumers place great faith in the FDA, and exploit this to their own advantage. First and foremost, FDA approval at all levels is never a guarantee that the product or device is safe and effective. Even in the best case, this label simply means that a product is generally safe enough to pass established administrative hurdles – usually meaning that the likely benefits outweigh the health risks.
But for most products, FDA approval or registration actually means far less. This includes products such as natural supplements, weight loss and exercise devices and supplements, and hair restoration devices, creams, etc. Many of these products visibly and noticeably tout their “FDA approval” or “FDA clearance.”
The FDA only approves prescription drugs and high-tech medical devices (for example, defibrillators implanted in the human body). All other products can be listed or registered with the FDA, but are not approved in this same sense. Even over-the-counter medications, such as pain killers and cold medicines, enjoy a far less rigorous testing and safety process in order to gain FDA approval.
For example, cosmetic products generally do not require any kind of clearance from the FDA. Cosmetic products which claim to alleviate specific conditions (for example, acne or dandruff) do require FDA clearance, but at a very low level. The FDA does not regulate vitamins, herbs or other dietary supplements at all. Consumers should thus be highly skeptical of any supplement claiming FDA approval or certification in any form.
Many manufacturers are able to flout the law simply because the FDA does not have the necessary resources to stop them. Others work around the law by, for example claiming FDA approval for a supplement that was “approved” as a component of a prescription drug, not as a product in its own right.
The procedure for devices enjoys a similar set of levels. High tech implantable devices, as discussed above, are subject to a process comparable to prescription drugs. Less invasive devices (such as X-rays, skin lasers, and even wheelchairs) enjoy reduced scrutiny and testing comparable to over-the-counter medicines. But even these devices can avoid true testing if they receive FDA “clearance” as being similar to a product already on the market. But that product, in turn, may not itself be effective.
Lesser devices, such as tongue depressors and most exercise equipment, receives no testing or scrutiny at all – the manufacturer simply registers with the FDA. We believe it is important that consumers are aware that the many products on store shelves touting their FDA “registration” have in fact simply filed with the agency, which has done exactly no investigation into their safety or effectiveness.
The simple rule for consumers is “let the buyer beware.” A claim of FDA approval, certification, clearance, or registration should always be taken with a grain of salt. Consumers should do research before buying – and remember, if a product sounds too good to be true, it probably is, even if it says “FDA” on the box.
For a free consultation with an experienced Chicago injury lawyer at Passen & Powell, call us at (312) 527-4500.