To the surprise of no one, the FDA has decided to go after your supplements once again. So, let's break down the new guidance rules and how they may affect you.
The "New" FDA Guidelines Explained
The newly enforced guidance focuses on the New Dietary Ingredient (NDI) notifications, which will require supplement companies to submit a "New Dietary Ingredient" application to the FDA, if the product fits into any of the following categories:
- The serving size changes
- The marketing strategy changes
- Any new ingredient is added to the product
- The manufacturing technique "chemically alters" an ingredient in the product
These guidelines are not really "new," but more "newly enforced." Back in 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed , one of the stipulations was that supplement companies had to notify the FDA when ingredients changed in their products.
If you read DHSEA, you will want to look closely to the wording in Section 8 titled "New Dietary Ingredients". For convenience sake, here's the definition word-for-word from DSHEA:
§8. New Dietary Ingredients(c) DEFINITION. - For purposes of this section, the term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.".
This is the thing: since 1994, only about 700 notifications have been filed with the FDA. At the time of this writing, there are currently over 55,000 dietary supplements on the market. Out of those thousands of products, NDI notifications have been filed on a mere 1.27% of them. The intention of these new guidelines is to get a better understanding of what ingredients are in the thousands of health products on the market.
However, in the meantime, what does it mean for your favorite health supplements? According to the definition laid out in Section 8 of the DSHEA Act, if the product was not marketed in the U.S. before October 15, 1994, the FDA may come and pull it off the shelf until the proper notification has been filed and approved.
When you look at the NDI notification guidelines from the perspective of consumers, it seems fairly clear that congressional intent was protection of the supplement-taking public. Notifications could be used as the basis for a list of dietary ingredients in commerce and to raise a flag if an ingredient with known safety risks is being used or advertised inappropriately; the last part is extremely important when you consider that there is a potential toxic level for any substance. Notifications must be viewed in the larger context of DSHEA itself, which was clearly designed to increase consumer access to information and products without drug-like regulation.
Without a doubt, these new NDI guidelines will help protect anybody that regularly takes supplements from companies that include cheap and unsafe ingredients. Of course, these new hoops the FDA is making supplement companies jump through will surely weed out some of the unethical companies that are only worried about their bottom-line, instead of the health and safety of people taking their product. But that's only going to affect a very small percentage of these companies in the long run.
It's only a matter of time before those same shady companies fill out the appropriate paperwork, get their notifications approved by the FDA again and start selling them to unsuspecting customers. Like always, it is wise to do the proper research on every ingredient, product and company BEFORE you buy from them.
According to, Daniel Fabricant, Ph.D., the head of the FDA's dietary supplements division, these new guidelines are not a "doomsday scenario" for supplement companies or anybody that regularly takes dietary supplements. However, it's hard to see it that way when the FDA now has the power to deny any ingredient in any product that was not marketed prior to the end of 1994 in the exact same form it is now sold.
Additionally, they require an application to be filed for every ingredient in a product. So if one product has twenty herbs in it, supplement companies will have to fill out twenty NDI notifications for that one product. On top of that, if another supplement company has a similar product formulation, they will also have to fill out NDI notifications for each product, despite the fact that another company already has. This seems excessive to many in the natural products industry since there are far fewer ingredients than potential products.
Filing NDI applications for every dietary supplement introduced into commerce, every formulation change, and every change in processing method will undoubtedly create an administrative backlog that has the potential to cripple the natural products industry and, as a direct consequence, keep safe supplements out of the hands of consumers, like yourself.
So, for example, let's take a look at our popular digestive enzymes supplement. In the product, we have a blend of twenty different enzymes that are beneficial for you. This means we will have to fill out twenty different NDI notifications and send them to the FDA. Accordingly, any of our competitors that sell a different enzyme supplement, will also have to fill out numerous NDI notifications, even if their enzymes are the exact same as ours.
That's just one product example. There are hundreds of different categories of dietary supplements out there. Just think about how much paperwork the FDA is going to be bombarded with in upcoming months. How quick will they be able to approve these notifications?
If the worst case scenario pans out, the FDA could literally pull all of your favorite health supplements (created after 1994) off the shelves, at least until the proper paperwork is not only filled out, but also approved.
With so many companies now rushing to fill out the NDI notifications, one can only assume that it is going to create a mountain of paperwork for the FDA, which will take time to sift through and analyze. There are a lot of unanswered questions floating around out there, and seemingly, nobody to answer them.
How long will it take for the FDA to approve the new ingredients? Will they forbid supplement companies from selling their products until the notifications have been approved? What happens with the companies when their products are in limbo? Will people lose their jobs in this already tough economy?
Of course, this is a worst case scenario, and not likely to happen. But, it could. The FDA does hold that unregulated power to blindly shut down supplement companies and put thousands of people out of work. And that is where this gets ugly.
Is all this really necessary?
According to the latest report (PDF) from the American Association of Poison Control Center's National Poison Data System , dietary supplements/herbal medicines/homeopathic remedies resulted in only ONE reported death in the year 2009. Yes, you read that correctly – ONE DEATH.
While no deaths are acceptable, in that same time period, Aspirin accounted for 18 deaths. Acetaminophen played a role in 170 deaths. Cardiovascular drugs accounted for 47 deaths. Muscle relaxers accounted for 3 deaths. In total, pharmaceuticals accounted for 497 deaths!
UPDATE — 08/14/2011:
Since I posted this article a few days ago, I have had some questions on the status of the draft guidance and whether it has actually been passed. I’ve spoken to some industry insiders about the guidance and have basically been told that it is a wait-and-see situation. The FDA published it in the Federal Register on July 5th of this year, but there is an open comment period ending on October 2nd.
The comment period allows trade organizations, companies and individuals to make their opinions heard regarding the potential effects of changes, or, really, proposed enforcement in this case. If you read the information posted on the FDA's site, it states that it is for "comment purposes only" and that the guidance "contains nonbinding recommendations ...not for implementation." That means that this is the time to make our voices heard: I strongly encourage everyone to participate by commenting about how the notifications could negatively affect the availability of vital supplements.
The new guidance seems a little bit like giving everyone a ticket that drives a car capable of going over the speed limit, just in case they drive too fast one day. Personally, I think that it makes more sense to just catch the people that actually break the law. Of course there are a number of other organizations and companies that are very concerned about an undue burden on supplement companies that would likely severely limit what you can buy, maybe even supplements that you have been relying on for years. Below are a few that are advocating for your health freedom; please take the time to make your voice heard while it still can make a difference.
What You Can Do:
- Sign the Petition from Life Extension
- Fax the petition to the FDA at 301-443-9767
- Call the FDA and voice your concern at 1-888-7233366
- Send a letter to your Representative and Senators
- U.S.Food and Drug Administration. Dietary Supplements guidance documents.
- Office of Dietary Supplements. Dietary supplement health and education act of 1994. National Institutes of Health. 1994 October 25.
- American Association of Poison Control Center. (PDF). http://www.aapcc.org/dnn/Portals/0/correctedannualreport.pdf/ (last accessed 2011 August 11).
†Results may vary. Information and statements made are for education purposes and are not intended to replace the advice of your doctor. If you have a severe medical condition or health concern, see your physician.