New FDA Office of Dietary Supplement Program

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FDA Office of Dietary Supplement Programs

Important Information Regarding the New FDA Office of Dietary Supplement Programs

Today, the FDA announced the launch of its new branch which they named the Office of Dietary Supplement Programs (ODSP). This new branch will cause some changes pertaining to how the FDA regulates dietary supplements, despite the fact that it’s an older FDA program that is just now getting its own separate office. The ODSP used to be a branch of the FDA’s Office of Nutrition Labeling and Dietary Supplement Programs.

What changes will the new branch bring to the market of dietary supplements? Does the new office have more power to influence the dietary supplement market? Keep reading.

The Booming Dietary Supplement Industry

This surge in popularity of dietary supplements has been going strong for the past 20 years and seems to get stronger with every passing year. This continuous boom has prompted the FDA to alter how it deals with dietary supplement manufacturers and marketers, due to nefarious methods used by some to sell their products. Not to mention because of the sheer volume of supplements available in the market and how many people buy them per year.

In the past, the FDA only lived up to the F and D in their name. That means that they only primarily only dealt with things that were classified as foods or drugs. Since dietary supplements fell under neither category, the FDA didn’t bother regulating them. That oversight led to manufacturers taking advantage of the free reign they were granted to make outrageous claims about their product in hopes of capturing a portion of the large market. The only limitation that manufacturers faced was that their claims couldn’t pertain to the ability to cure any particular disease or illness.

Nevertheless, only one branch of the FDA was responsible for controlling the massive dietary supplement industry in the United States. This branch was initiated 2 decades ago when the dietary supplement market was first blooming. Things have obviously changed in that time. To put it into numbers, the market was bringing in a grand total of $6 billion in yearly sales 20 years ago. Now, they bring in $35 billion.

In a press release, the FDA stated that, “Elevating the program’s position will raise the profile of dietary supplements within the agency, and will enhance the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this rapidly expanding industry.”

In short, the FDA realized how much the dietary supplement market has grown and that much more regulation of said market was needed. The problem was that the FDA lacked the funding to create a new division that looked over the massive industry because it wasn’t viewed as an important thing to regulate within the FDA.

However, the birth of the Office of Dietary Supplement Programs will alter that perception and bring the issue of regulating the diet supplement industry to the forefront.

Functions of the ODSP

The Office of Dietary Supplement Programs will be responsible for dealing with dietary supplement manufacturers who release potentially harmful products. A big problem within the market is that makers whip up wild concoctions of vitamins and minerals and call it a diet supplement. Due to former weak regulation, that product could easily end up in the market and consumers would buy it, take it, and get sick because of it. The ODSP will do its best to tackle that issue head-on.

On top of that, the ODSP will look to tackle the corruption in the dietary supplement industry. The lack of regulation gave rise to a lot of fraudulent practices being used by various companies.

Another function of the ODSP is to carry out the dietary supplement good manufacturing practices (GMP) regulation. What is this? It gives special attention to claims of GMP violations that:

— Possibly call into question the safety of a product

— Pertain to a lack of sufficient or even valid labeling of a product, which puts buyers at risk

— Could lead to the misleading of consumers through questionable advertising and insufficient or incomplete labeling of all of the ingredients in the supplement

Another function of the ODSP is one inherited from its predecessor – which is the ability to take dangerous products out of the market. Hopefully with the additional funding and importance given to this branch, it will be able to more effectively deal with the plethora of harmful products floating around. The ODSP will be able to work in conjunction with the FDA’s Center for Drug Evaluation and Research in this capacity to effectively weed out the harmful products being marketed as supplements and get them out of the market ASAP. This cooperation will be especially helpful as it pertains to finding products that masquerade as dietary supplements but are actually harmful pharmaceutical drugs.

All of these functions were performed in one way or another by the predecessor branch, but that previous branch never had the amount of funding, power, and scope that the new ODSP has. This is very good news for consumers of dietary supplements, as way more of the crappy fake products with overblown claims and BS endorsements will be taken off the market.

The Effect the ODSP Will Have on the Whole Dietary Supplement Industry

If a company is completely honest and straightforward about the benefits and ingredients of their products, they will have nothing to worry about. Well, that’s implying that their products are safe, of course. In fact, a majority of the big boys in the dietary supplement market were in support of the expanded role of the FDA in the market through this new office. The letter that announced the creation was approved by the big wigs of various companies such as American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), Natural Products Association (NPA), and United Natural Products Alliance (UNPA).

Basically, this wasn’t the FDA trying to screw over the entire industry, no matter how reputable the company is. This is just an effort to get rid of the bad apples.

The companies who are looking to scam their consumers will have the FDA breathing their necks all the time now thanks to the ODSP and the additional funding coming along with it. The playing field will be much more evened for those nice and honest companies who release legitimate products.

No restriction or law has really changed with the emergence of this new organization. It’s just that the organization has more power and money to enforce the already set laws on a much larger scale.

What Exactly Are These Laws That Are Already Set in Place?

In 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law. It’s the FDA’s, and more specifically the ODSP’s, job to enforce the provisions of this act on the dietary supplement industry.

The DSHEA makes it a point that dietary supplements are to be treated differently than foods and drugs. This means that a whole new set of regulations had to be put in place to ensure the quality of dietary supplement products being released to the public.

The two key points of the act are:

It is unlawful for dietary supplement manufacturers to mislead consumers with false advertising about their product. Many of the big companies have set up specific chapters within the company to deal with analyzing the safety of their product and ensuring the proper labeling is present so that the product passes all of the DSHEA requirements.

Tackling companies that try to sell misleading products to consumers is the FDA’s responsibility. The FDA cannot do anything until the product has already been released into the public market. This means that a good amount of people can be scammed and even be harmed by unsafe products before the FDA has a chance to take down the manufacturers of said product.

There is a glaring problem here and I’m sure you’ve seen it. The companies behind the dietary supplements have the power to decide if their product is safe for human consumption or not. Now, of course, this is nothing to worry about if the company is honest and reputable. Unfortunately, this freedom is abused by many of the smaller companies who are looking to strike it rich quickly and then drop out of the market once they’ve made a pretty penny, with no regard to the potential harm that they’ve done to consumers.

A company literally has the freedom to cook up some insanely dangerous concoction, have an “inspection team” full of “established scientists and drug experts” put their stamp of approval and safety on it, and then market it as a miracle weight loss pill. And guess what? They’ll be able to rake in the profit until the FDA finally finds out about it and takes them down.

The creation of the ODSP is definitely a step in the right direction for the entire dietary supplement industry. It will give the FDA more power and a much larger budget to carry out the laws set forth by the DSHEA. That said, new laws should be put in place to prevent dangerous products from hitting the market in the first place. Companies should NOT be able to perform their own safety tests, due to obvious biases and the bad intentions of some companies in the industry.

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