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FDA’s New Office of Dietary Supplement Programs
The FDA announced big changes to the way it manages dietary supplements today: the FDA created a new division called the Office of Dietary Supplement Programs, or ODSP.
The new office is actually just an elevation of an existing program. Previously, the organization was a division under the Office of Nutrition Labeling and Dietary Supplement Programs.
What do you need to know about this new office? Does it change the nutritional supplements industry in any way? Let’s find out?
The Nutritional Supplement Industry Has Exploded with Growth Over the Past 2 Decades
Over the past few years, it has become clear that the FDA needed to change the way it worked with nutritional supplements.
Previously, the FDA dealt mostly with foods and drugs. Since nutritional supplements were not foods (you don’t eat them as a main part of your diet) nor were they drugs (you don’t take them to treat a medical condition), they fell through the cracks of FDA regulations.
This meant that diet pill manufacturers could make just about any claim they wanted without necessarily proving that claim.
The only thing nutritional supplement manufacturers couldn’t really do was make claims that their supplement treated a specific illness or disease.
In any case, the entire nutritional supplement industry in America was managed by one division of the FDA. That division was created 20 years ago.
Over the past 20 years, the industry has grown from about $6 billion to $35 billion in annual sales, according to the press release from the FDA:
“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 other words, the FDA recognized that the nutritional supplement industry needed further regulation, but they didn’t have the funding to allocate a significant amount of resources to that division because of its lack of importance in the bureaucratic structure.
The creation of the Office of Nutritional Labeling and Dietary Supplement Programs will change that.
What Will The ODSP Do?
The ODSP is tasked with the following responsibilities:
-Take action against nutritional supplements that may cause serious harm to the consumer (like nutritional supplements that claim to treat serious diseases)
-Crack down on widespread economic fraud in the nutritional supplement industry
-Enforce the dietary supplement good manufacturing practices (GMP) regulation, giving priority to cases in which GMP violations:
-Potentially compromise product safety
-Fail to ensure product identity, which could potentially jeopardize consumer safety
-Result in consumer deception, which happens, for example, when manufacturers do not verify the identity of their raw materials
-Remove supplements from the market that are dangerous to consumers
-Work in cooperation with the FDA’s Center for Drug Evaluation and Research to help remove products from the market that are falsely labeled as dietary supplements but actually contain pharmaceutical agents that could be harmful to the American public
Over the past few years, the office in its previous form performed all of these roles. The main difference with this new office is that it will have increased oversight, funding, and power to take further action against supplements.
Ultimately, that means the low-quality, fraudulent supplement manufacturers will continue facing action from the FDA – the FDA will just be able to catch more of them now.
What Does This Mean for the Dietary Supplements Industry?
The FDA’s move was supported by some of the nutritional supplement industry’s big players. The letter announcing the move was signed by the leaders of the 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).
In other words, this wasn’t some under-handed move against the nutritional supplement industry.
Reputable manufacturers are looking forward to enjoying an even playing field.
Disreputable manufacturers – like the companies selling autoship scams and low-quality, overpriced supplements – are the ones who should be worried. For years, the FDA hasn’t had the budget to track down all of these supplements.
With the creation of the ODSP, the rules haven’t changed: although the enforcement of those rules will be ramped up.
What Are the FDA’s Rules About Nutritional Supplements?
To recap, the FDA’s rules about nutritional supplements continue to be the same. The FDA’s duty is to enforce the Dietary Supplement Health and Education Act of 1994 (DSHEA).
That act mandates that dietary supplements are covered under a different set of regulations than those covering conventional food and drug products.
The two main portions of the act include:
-Manufacturers and distributors of dietary supplements and dietary ingredients cannot market products that are adulterated or misbranded. Firms are responsible for evaluating the safety of their products and labeling them to ensure they meet all DSHEA and FDA requirements and regulations.
-The FDA is responsible for taking action against any manufacturers that distribute adulterated or misbranded dietary supplements. The FDA can only take action after these supplements have reached the marketplace.
You can see the problem here: the FDA passes off the regulatory duties to manufacturers. These manufacturers are responsible for labeling their own products and ensuring those products are safe to use.
The manufacturers can release a product, sell it on the market place, and make money from it without having any oversight from a third-party regulatory group. Only after the product reaches the market can the FDA take action.
Meanwhile, it’s the FDA’s duty to keep the manufacturers honest. That means they need to routinely test products, check for fraudulent scams – like supplement autoship programs – and penalize manufacturers who break the rules.
Ultimately, the new ODSP will give the FDA greater power over its enforcement of the above regulations. It will not, however, change the rules governing nutritional supplement manufacturers.