After I published what SOMADERM recently passed on April 27, a reader responded to hope that I could explain the FDA certification that this product calls it. In fact, several readers have asked me about the FDA certification. They said that a certain health product is certified by the US FDA, but why do I say it has no validity?
In fact, I published an FDA certification on 2017-12-6, which is true and false, but few people dig out this old article from three years ago to read, so I decided to write this new article. At the same time, I will also provide newer and more complete information.
The full name of the US FDA is Food and Drug Administration, while the Chinese name is Food and Drug Administration. The name is sensible, and the Food and Drug Administration is responsible for the control of "Food" and "Pharmaceuticals". There is a page on its website called Is It Really ‘FDA Approved? (Is it really FDA approved?). It says that people often see a company's website or ad that is called "FDA Approval", but that's not necessarily true. It also said that the US FDA only approves or certifies two major categories: (1) new drugs and biopharmaceuticals, and (2) medical devices.
New medicine is a chemical drug used to treat diseases, so it must pass the first, second, and third phase clinical trials to prove "Temporary Effectiveness" and "Safety". Biopharmaceuticals are non-chemical drugs used to treat diseases, including proteins, cells, serum, vaccines, etc. used for treatment, and they must also pass the first, second, and third phase clinical trials to prove "Temporary Effect" and "Safety".
The U.S. FDA specifically emphasizes (1) The FDA will not approve dietary supplements, and (2) The FDA will not approve structural functional statements on dietary supplements and other foods. In other words, the FDA will neither verify any health care product itself nor verify the function of any health care product. So, just see a health product sound or any FDA word or magazine, you can be 100% sure it is a snare.
The US FDA website has another page called Dietary Supplement Products & Ingredients (dietary supplement products and ingredients). It says dietary supplements include ingredients such as vitamins, minerals, herbs, amino acids and enzymes. Unlike drugs, dietary supplements are not used to treat, diagnose, prevent or treat diseases. In other words, dietary supplements cannot be called, such as "Reduce Pain" or "Treatment of Heart Diseases". This type of statement can only be used legally for drugs and cannot be used for dietary supplements.
The US FDA website also has another page called Information for Consumers on Using Dietary Supplements. It states that the FDA is not legally authorized to review the safety or effectiveness of dietary supplements before marketing. In other words, health products can be launched without FDA review at all. So, since there is no review, why might there be any health products certified by the FDA?
The US FDA website also has another page called Tips for Dietary Supplement Users. It says that dietary supplement manufacturers are responsible for ensuring that their products are safe before they go to market. They are also responsible for making sure the statements on their labels are correct and true. Dietary supplement products do not require government review before they are launched, but the FDA is responsible for taking action on any unsafe dietary supplement products after they are launched. If the FDA can prove that the sound of post-market dietary supplements is false and misdirected, the FDA can also take action on this.
From these information provided by the FDA, we can clearly see that the FDA will only take action on health products under two circumstances: (1) The user has adverse reactions, and (2) There are false or misleading claims. The first point is that as long as health care products do not cause health hazards to the public, the FDA will not ask. Regarding the second point, cunning health care product operators will certainly not declare that it has a temporary effect on product packaging, nor will they declare that it has a temporary effect on company websites. However, they will clamor for their products to be effective in various media (faces, as well as various “healthy “ websites). Since these voices are posted anonymous or pseudonyms, the FDA has no way to pursue them.
Readers often ask me why the FDA doesn't catch those messy health products. My answer is "I can't control that much". In fact, I issued a FDA to strengthen supervision supplement last year. The first paragraph is: The US FDA announced yesterday (2019-2-11) 12 warning letters and 5 online consultation letters issued to 17 companies. The 17 companies were found by the FDA and are illegally selling over 58 supplements that can prevent, cure or cure Alzheimer's disease and some other serious diseases.
The main content of this article is a letter issued by the FDA Secretary to the public, and there is a passage in it: Since 25 years ago, the … supplement market has seen significant growth.. …, now it has become a industry worth more than US$40 billion, and has more than 50,000 – possibly up to 80,000 more, or even more – different products. With the popularity of supplements, uncertified or misleading statements on the health benefits it may bring also increase.
From this paragraph, we can see that the FDA is very clear about the moisture and harm of health care products, but the problem is, how to deal with it? How to catch it? Therefore, for a consumer, the purchase, use and being cheated of health products is completely "One beating, the other beating", and the FDA cannot blame.
In this article by Archbishop's New Coronavirus Shui, I told you that there is a quiz group that has started selling chlorine dioxide beverages since 2006, saying that it can cure all diseases. Although many people have been hospitalized or even died because of drinking this drink in 2014, the FDA did not take action to rush into this scourge until this year during the COVID-19 pandemic. From this we can see that as a consumer of health care products, you should never expect the FDA to keep your health afar anytime.
Okay, I've talked about so much. In fact, readers only need to know two things: (1) All health products that are claimed to be "FDA certified" are cheating, (2) The consequences of using health products are completely borne by the user. The FDA can choose to intervene or choose not to intervene.
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