When looking for products to treat medical and health conditions, we want them to be safe, effective, trusted, and of high quality. Similarly, we want the same thing for the cosmetic items that we use to improve certain aspects of our appearances. With the huge market for such products and wide range of options, the drugs and cosmetics industry often becomes an ideal target for counterfeiters and fraudsters to exploit.
Thankfully, the government, which is responsible for ensuring the wellbeing of its citizens, has created the Philippine Food and Drug Administration, or FDA. FDA’s mandate is to “ensure the safety, efficacy, or quality of health products, which include food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, radiation-emitting devices or equipment, and household/urban hazardous substances, including pesticides and toys, or consumer products that may have an effect on health and require regulations as determined by the FDA.”
In short, the FDA is responsible for making sure that the drugs and cosmetic products that you get on the market are safe, effective, and true to their claimed effects and benefits. Now you might be wondering if the products you are currently using are FDA approved. And the reason why you are here, is Pynocare FDA approved?
Counterfeits vs Unregistered Products
As part of the FDA’s mandate, we often see public health warnings against the purchase and use of specific counterfeit products due to harmful effects or because they are unregistered. A lot of these products are often touted as “miracle” supplements, skin care products, or drugs that could rid you of all your problems.
Counterfeit products are straight-up fake copies of well-established brands, appearing to be the same in appearance and use, but are sometimes cheaper. However, in reality, they contain unknown substances, are manufactured by dubious manufacturers, and are sold by obscure distributors to the unknowing public, potentially causing severe harm to people who happen to take or use them. Disturbingly, a lot of the counterfeits on the market today are imitations of household name drugs, while a number of them have incredulous claims despite not being properly tested for such claims.
Unregistered products, on the other hand, are items that are available on the market but have not undergone the proper verification process of the FDA. They can also be products that have existing, valid licenses but have expired because proper protocol wasn’t followed by the pharmaceutical company that has its marketing authorization for its renewal. They don’t necessarily pose any hazards outright, but since they haven’t undergone the proper checks, the risk for unwanted effects is always present.
How Does a Product Get FDA-Approved?
Now that the difference between counterfeit and unregistered products is out of the way, it’s time to answer the question why you might be here: is Pynocare FDA approved? The short answer is yes. Pynocare is the only FDA approved anti-melasma medication that is marketed today in the Philippines.
But how does a product like Pynocare get such approval in the first place? As mentioned, the directive of the FDA is to ensure the safety, efficacy, and quality of health products, including drugs, supplements, and cosmetics. The approval process is rigorous and highly technical. For a manufacturer, importer, or distributor to get their products onto the Philippine market, they first need to comply with the FDA’s requirements.
The FDA goes over technical documents that details the contents, action, and other aspects of the product. They also pore over clinical trial results, manufacturing specifics, labeling requirements, and many more. The whole process can take weeks or months to complete. All of these security measures are instituted not to waste time, effort, and resources but are put in place to ensure that the public has access to safe and quality products.
Pynocare’s FDA Status
In the case of Pynocare, it is classified by the FDA as a prescription drug with a valid license to market until 2026. All of this information is publicly available at the FDA’s verification portal. So if you are still asking, “is Pynocare FDA approved?” then you can head to the verification portal and see for yourself. You can also use this portal to check if a certain product that you are interested in is licensed and approved to be marketed in the Philippines.
What happens then after the license to market expires? Does this mean that Pynocare is still FDA-approved? Technically, yes, companies apply to renew their authorizations months prior to their license’s expiry date. They would need to comply with any update that the FDA requires and provide documents to support their application.
Benefits of Pynocare
As mentioned above, Pynocare is the only FDA-approved drug on the market today for the treatment of melasma. Its claim is backed by clinical studies and, consequently, approved by the FDA. Products cannot make claims about their actions without proper studies being conducted around them. Below are some of the benefits of Pynocare that can help with melasma.
Reduce hyperpigmentation: Pynocare is well-known for its effectiveness when combating the appearance of dark spots or hyperpigmentation on the skin. Pynocare works by regulating the production of melanin in the skin to reduce the appearance of dark spots.
Protection from free radicals: The beta-carotene present in Pynocare is helpful in improving skin smoothness and elasticity and maintaining youthful-looking skin since it is an antioxidant and it works by combating free radicals caused by environmental stress.
Helps prevent sun damage: Tocopheryl acetate, especially when working with ascorbic acid, can help prevent sun damage. Studies suggest that using tocopheryl acetate with ascorbic acid helps protect the skin from damage due to UV exposure.
Despite the Philippine FDA’s best efforts to safeguard the public, there are still some instances when counterfeit and unregistered products make their way into the market. When considering buying a product, it is important to ask, “Is this FDA-approved?” You can always check the FDA verification portal or watch out for announcements made on FDA’s Facebook page. You can also do your part by reporting suspected products to the proper authorities such as the FDA.
PYNOCARE (Procyanidin + Ascorbic Acid + Betacarotene + d-Alpha-Tocopheryl Acetate)
The first and only oral medicine that is clinically proven to reduce Melasma or dark spots formation in just 8 weeks. Unlike creams, lotions, and gels, it has MSCC or Melasma Skin Clear Complexion Complex formulation that deeply penetrates the inner layers of the skin, to help normalize melanin levels, thus minimizing the appearance of dark spots in a short time.
Mega Lifesciences Limited Inc. or Mega We Care, is actively involved in helping millions of people have access to safe, effective, world-class quality nutritional & herbal supplements, OTC, and ethical products.