Based on opinions and views from critics, researchers, and experts from diverse fields, there has been an impressive degree of consensus across the general public that the FDA (Food & Drug Administration) is a mess of a federal agency. In fact, there are innumerable articles out there published by numerous aggregate health websites, raising their concerns about the problems that mar the FDA, which, while impeding how it runs, are utterly incongruent with its primary objective: protecting and promoting public health. It is clear that the FDA has been on a warpath, and we tend to suspect that the reason is that the government has been running broke for a while now – why? We all know that the FDA is an important cash cow for the federal government, and frankly, they do whatever they want to do because people are terrified of them. In the past, we have had to deal with the EPA (Environmental Protection Agency) in an issue involving CARB (California Air Resources Board) over and over again, and as frustrating as it was, dealing with the FDA makes you feel like you are dealing with a mafia – they simply come to take their protection money and leave.

You may have noticed how they get loud and aggressive in what you may call ebbs and flows. Remember that a while before the COVID-19 pandemic, they had been quite aggressive and then went quiet for a while, only to become aggressive again and start going after people who championed natural and holistic remedies during the pandemic, then they went quiet, but that did not last long. To a larger extent, the only area they consistently go after is the supplement industry, which, FYI, is extremely regulated, although most people think it is not. Worse is that the regulation is so inconsistent that there is no specific statutory framework you can walk through to understand how they regulate this industry – only a hodgepodge of things that they keep doing and saying about how it should operate.

For instance, let us look at a directory the FDA has known as the ingredient advisory list. Ideally, the directory includes commonly used terms for specific ingredients and agency statements and actions. You would think of them as constituents for, say, new drugs, but there is no particular testing for them, but just a list that they manipulate as the basis for going after companies in the supplement industry. Sometimes, with nothing to say, they take off supplements known to have health benefits and that are preferred by most people in health promotion efforts, such as weight loss, especially in a country with a significant number of people with obesity. Simply, ingredients fall off the advisory list, but the level of bureaucracy cannot allow the FDA to even provide a legitimate reason for the same. The problem is that any health benefit claims a company makes regarding a certain drug containing a particular supplement or ingredient is automatically construed by the FDA as a newly-developed drug requiring urgent regulation – ultimately being clobbered, required to comply with a dozen stupid regulations, and eventually having to part with a huge bunch of money in the process – all in the name of lacking FDA approved research, certification, or the like, and therefore, a violation of the law, which requires the FDA to take money and nothing else.

In a nutshell, the FDA would rather see Americans suffer from pain, live with disabilities, and die than pick up the pace and accept the fact that we are living in an era where people need and trust innovative drugs and devices. As an American federal agency, it is then clear that there is a problem with the FDA. Unfortunately, there is no lobby for the supplement industry, of which we would be a member if one existed. Accordingly, based on our opinion as Miletti Law@, we have in this blog and the video it has been adapted from, discussed three things that the FDA needs to fix in order to get their act together.

Consistency

One thing the FDA is very good at is being inconsistent – today, they say something is bad, and tomorrow, they change their stand and say it is good or come up with something crazily different. We all know that since humans walked on earth, Vitamin C has been good for human health, but the FDA says it is not good because it is championed as a good supplement during COVID-19. The only thing that the FDA is consistent at includes welcoming rogue bigwigs who buy and support their ideas, despite how ridiculous they are. Any legitimate business owner knows how challenging it is to set up and propel a business forward when regulatory agencies have inconsistent regulations, guidelines, and laws. Consistency of laws and regulations assists businesses in accurately anticipating and predicting shifts in the market or at least safely adapting to changes in market forces. In light of this, the FDA needs to be consistent in their regulations, guidelines, and laws. Due to the complexity of the health industry, the FDA cannot merely add something to the ingredient advisory list tomorrow and then remove it a month later whenever they wish to.

Standard Labelling Process

This is another area in which the FDA has failed terribly. The FDA is aware of the numerous products, whether cosmetics or health-promotion foods, which require labeling. To ensure a standard and efficient labeling process, they should, for example, provide a feature where a manufacturer or company would just visit their website and key in what their product is, after which the labels are systematically printed. The system should be modeled in such a way that it meets the least minimum requirements that would eliminate the hiccups experienced during the labeling process. Unfortunately, the FDA is best at making little caveats – for example, if you have a product with dietary fiber or an artificial sweetener in it – there are always some inconsistencies that sort of throw everything off the rails. The standard should also be explicitly consistent regarding what you can say and what you cannot. Remember the case of Dr. Mercola, who, not long ago, received a warning letter to the effect that what he was promoting and selling as vitamins C and D was illegal because it is like a new drug. Wait‼ All your life, probably since humans first walked on earth or 10,000 years of their existence, you have been aware that vitamin C is good for your immune system. In short, the FDA needs to have a standard labeling process that is consistent through and through.

Affordable Testing and Certification Process

Most people can agree that FDA testing and certification, especially the former, comprise some of the most expensive processes out there. For example, in the past, testing involving car parts with the EPA would cost up to a whopping $4,000. This has been the case for most testing of aftermarket products related to emissions. Now imagine how much it would cost you if you had five or six different items that required testing – then it might force you to do away with the business altogether because of the outrageous testing costs involved. Mind you, you have not been allowed to sell even a single product yet. How would you even possibly introduce your product into the market when you cannot even afford to get your foot off the ground?

In essence, our theory is that this is “old money” protecting their industry. We all know how cartel and mafia organizations operate to protect their own interests and fight tooth and nail to maintain and grow their share of the market. For instance, when it comes to emissions, it is easy to learn that the only groups that can “afford” the standards and bureaucracy include very few groups, such as Ford and GM (General Motors). So, if you are an aftermarket manufacturer who invented, say, a great new product for an air filter that performs excellently well with emissions, you never get to sell it because it is illegal and unless you have the testing prior, but that you cannot afford, you do not get to join the league of the old money big wigs. It is as if the exorbitant costs have been placed strategically to ensure you cannot afford FDA testing and certification.

In short, the FDA needs to fix those three things, including consistency, standard labeling, and affordability of the testing and certification process, to get their house in order. This also includes providing specific information about intricate details, such as what you can say or not, among other things. With that, feel free to view our video accessible at https://www.youtube.com/watch?v=2okKNN1JXBA, and get it yourself directly from the horse’s mouth. Otherwise, in case you need further clarification regarding the information shared in the video and this blog post or require our services, we are just a call or email away!

As we continue dropping knowledge bombs every day, stay tuned for more educative videos, inspiring training, & legal advice. In the interim, if there are any questions or comments, please let us know at the Contact Us page!

Always rising above the bar,

Isaac T.,

Legal Writer, Author, & Publisher.