The US Food and Drug Administration (FDA), issued warning letters to manufacturers of medical devices marketed for hair growth products, weight reduction, spider vein removal, as well as injections fillers. The FDA’s task is to clearly differentiate between medical devices and cosmetic products. The FDA is aiming to clearly define the differences between the two so there is no confusion.
Although the devices are used to affect appearances, any devices used to treat abrasions, bone structures or bodily functions, would be categorized as medical devices, according to the Federal Food, Drug, & Cosmetic Act (FD&C Act). So as an example, all contact lenses are considered medical devices, since they provide a medical function.
The letter was sent to Thomas M. O’Brien, CEO, Eclipse Aesthetics. The product under scrutiny was the Eclipse MicroPen Elite. According to the FDA, Eclipse Aesthetics did not have an approved application for premarket approval. The company also did not inform the agency of their intent to introduce the device into the market.
The Eclipse MicroPen Elite system allows for controlled collagen induction therapy by creating micro-injuries in the skin, which trigger new collagen synthesis, and is marketed to treat conditions such as the appearance of moderate to deep wrinkles and stretch marks.
The letter requested Eclipse Aesthetics to immediately stop commercial distribution of the device and notify the FDA since it was mislabeled, and warned the company that strict action could be taken against it if it did not follow through.
The FD&C Act requires medical device manufacturers to be market cleared before they can be sent for production. [FD&C Act, section 501(f)(1)]. The law currently does not offer clearance or approval to market cosmetic products or ingredients (an exception is color additives, which are covered separately in section 721 of the FD&C Act).
Additionally, all medical devices are subject to the Quality System Regulation (21 CFR part 820) whereas cosmetic products are not subject to this regulation.
According to the FDA, a medical device is defined as:
“…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is – (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.” [FD&C Act, section 201 (h)]
According to the FDA, cosmetic products are:
“… (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.” [FD&C Act, section 201(i)]
This warning letter comes as little surprise, since many cosmetic products contain harmful ingredients that can harm the body. Cosmetic products such as mascara contain lead sulphide that causes infertility, mental disability and neural degeneration. Many skin creams and lotions, contain radium, so instead of making skin healthy, these products expose the skin to radiation.
Moreover, many cosmetic products contain parabens that are extremely dangerous to pregnant women and their babies. According to a new study, makeup products, if used extensively by pregnant women, can affect their unborn child’s health. The study found that parabens used in cosmetics can cause severe health problems in fetuses such as premature birth and decreased bodily activities. Parabens can act as estrogens by confusing estrogen receptors, which can lead to breast cancer and cell proliferation. Parabens are not harmful on their own, but combined with other toxic elements they can be quite dangerous.
Parabens mimic estrogen, tricking the body into thinking that they are actually estrogen. The more a woman is exposed to estrogen, the greater the chances of aggressive cell reproduction, which can lead to breast cancer. The compound can be more toxic when introduced in the body. The results of the study are quite shocking, as it shows that even at low volumes, cancer growth was quite rapid.
The FDA, with the help of Federal Trade Commission (FTC), also issued guidelines for mobile health app developers, so that their apps would be more in line with the functionality they provided and would help to securely and clearly identify health information.
The FDA recently released a draft containing guidelines for medical device manufacturers who build 3D medical devices. Since the number of 3D manufacturing companies is rapidly increasing, a set of rules and regulations that guided the companies on the manufacturing process is needed.
Many healthcare devices are quite expensive and are not readily available. Therefore, more and more manufacturers are looking towards 3D technology for cheaper alternatives that do not compromise on quality, practicality and functionality.
Since the massive influx of 3D printed devices, it is becoming increasingly hard for the FDA to keep a check and balance on all devices. Consequently, instead of correcting each device, they introduced a draft of guidelines for the manufactures to make healthcare more accessible for everyone.
Many medical devices and health support gadgets can put users at risks and can even be fatal if not properly tested. To equip patients with the latest scientific breakthroughs healthcare technology has to offer, medical devices need to be approved through regulations. It is also highly important to safeguard patients’ health by limiting harmful products, whether they are cosmetics or medical devices, by limiting the production of items that have not been tested properly.
In order to accurately test, check their validity, reliability and functionality, medical devices and cosmetics need to be properly differentiated and defined. They can then be categorized accordingly so that specific rules and regulations can be applied to them.