There was great relief amongst some quarters when the FDA decided to update its guidelines in 2016 and start to implement regulations in relation to the sale of dietary supplements.
Unfortunately, such relief was short-lived. On close inspection, it soon becomes clear that the guidelines are hardly watertight, and simply focus on premarket safely. It means that any manufacturer who is looking to release a product into the supplements market now needs to notify the FDA a minimum of 75 days before it hits the shelves. A further caveat is that this notification need only occur if the product in question contains a brand new dietary ingredient (which is usually the case when it comes to fat burning supplements).
In comparison to the pharmaceutical industry, the regulations are minor. Unlike pharmaceutical products, the FDA has no say in relation to the potency, purity or biologic activity of supplements. Ultimately, the authorities don’t have to clear a product on this basis before it hits the shelves. The only power that they do possess is in relation to the labelling. It’s here where they can moderate any claims which are commonplace on packaging, and ensure that everything which is stated is completely accurate.
Unfortunately, this is not all. Something that drug makers are held accountable for, and rightly so, is the potential adverse reactions that their products can cause. This, quite alarmingly, is completely voluntary in the supplements market. It means that supplements manufacturers can be as mischievous as they like when it comes to reporting these issues – and many will simply point out the “minor” issues that are unlikely to alarm their target consumer. Many of these target consumers don’t trust medical realm anyway, meaning that they are completely open to the text that is contained in product instructions which is meant to detail possible side-effects.
As you may have gathered, we have only covered the tip of the iceberg. While one might assume that the Dietary Supplement Health and Education Act of 1994 might protect the consumer to maximum effect, this isn’t the case in the slightest. In reality, the act allows any product with “established” ingredients to be sold without any questions asked regarding the effectiveness or safety. When the term “established” is used, it refers to ingredients that were being sold prior to 1994 (in other words, before the law was passed). Suffice to say, this is no guarantee of safety. In contrast, when the pharmaceutical industry is scrutinized, no product can be made available for the market until the FDA receives clear proof that it is completely safe for the end consumer.
Following on from the above, one assumption might be that the pharmaceutical companies are up-in-arms about this situation. After all, why should they have to play by different rules?
This is when the story takes a turn for the interesting. Even though they might have to pay for costly drugs trials and everything else that is required to show that their drugs are safe, they aren’t overly disturbed by the ease in which supplements are passed to the market. This is because many of these manufacturers have got their fingers in both pies. In other words, they make both drugs and supplements.
To coin an example, Big Pharma and Big Herba are the very same. While one might need to be FDA approved, the other is being manufactured in the same environment but without any tests. Instead, fancy marketing spiel is provided to the consumer and the end result is the “natural” and “wholesome” products that fool many and line a lot of pockets. Of course, there are some supplements companies who only dabble in this field. In the grand scheme of things, this is a very small number, and they only represent a tiny fraction of the entire supplements market – which is said to be worth $23 billion-a-year.
The fact that these pharmaceutical companies have made headway into the supplements market really shouldn’t come as a surprise. They have everything in place; but the big difference is that they can now make products with much lower costs than what they incur with drug development.
Perhaps the biggest surprise of all is that the tables are starting to turn. For years we’ve seen the pharmaceutical brands dabble in supplements, for the reasons that we have just outlined. Now, the opposite is occurring, with supplements manufacturers starting to create their own drugs.
Sound scary? Well, one of the most well-known brands in the world is following this path, and they seem to be doing it very well. Nestle have developed their Nestle Health Science; a subsidiary which employs around 3,000 people all around the world and is worth approximately $2 billion to their business. They bring the likes of high-protein shakes to the market (under Boost), as well as various energy products under their Meritene brand.
Following this success, they are now setting their sights far higher and on the pharmaceutical industry. They are investing in human trials for various products; one of which looks to tackle Chron’s disease. Considering the innovation at stake here, one can only assume that this is a positive move for the market.
Nevertheless, the message is still the same – the difference between supplements and pharmaceuticals from a legal perspective are still far apart. This is something that is proving to be an increasing danger for the general public, although experts do think that the two industries are operating under extremes. On one hand, some believe that supplements require far more regulation. On the other, some believe that pharmaceutical companies have excessive red take to navigate. The optimum solution is something that comes in the middle of the two, but following years of debate it remains to be seen whether such a solution is ever going to happen.