The FDA just dropped a bombshell.
And you need to know about this.
Supplements that you take regularly may not be available much longer if FDA gets is way.
They issued a document that described what the dietary supplement industry should do to meet their NEW DIETARY INGREDIENTS policy.
The New Dietary Ingredients (NDI) is not law yet. There is a comment period that’s about to end shortly.
If NDI becomes law:
- Only ingredients found in the food supply can be sold as supplements.
- (My comment: if we find a new herb or plant in a jungle that the natives have been using safely for centuries, it cannot be sold as a supplement. Pharmaceutical companies may take this herb and turn it into a drug if they choose or supplement companies may submit an NDI request – see below.)
- Every single ingredient and every supplement formula would be required to get a New Dietary Ingredient Notification.
- FDA has rejected 8 out of 10 NDI notifications.
- A mountain of money and work is required to file an NDI notification. Dietary supplement companies will have to hire consultants, lawyers and nutritionists to file NDI notifications.
- (My comment: in some cases, if the FDA requires toxicology or safety studies, it could cost hundreds of thousands of dollars. When companies are burdened with costs, guess who ultimately pays for it? Yup. YOU! Or the company goes belly up.)
- Every company selling already-proven-safe Vitamin C or D or fish oil will still have to separately file NDI notifications. Even if they are all selling the exact same ingredient!
- (My comment: this is insanity! This is government bureaucracy at its worst! There are hundreds, if not thousands, of companies in the supplement industry. They all must file the same notification for the same ingredients.)
- If a company has two products – a fish oil and a Vitamin D – that have both been independently approved by the FDA, and then the company decides to combine the two ingredients, a new NDI will have to be filed all over again.
- (My comment: this is a sure-fire way to kill innovation and creativity. Nutritionists and supplement companies will keep their formulas to themselves. It will prevent a good idea from ever seeing the light of day.)
- Nobody knows how long this FDA approval process will take.
- (My comment: Good formulas could get stuck in this bureaucratic quick sand for months.)
In FDA’s defense
The FDA must safeguard people from harmful substances.
And consumers have the right to expect safe products…and that the products they buy perform as claimed. We all agree.
But existing laws and the current level of FDA authority are more than sufficient to accomplish this!
Just for perspective sake…
Number of deaths per year due to supplements: 1
Number of deaths per year due to OTC pain-killers: 500
Number of deaths per year due to food safety: 5,000
Sure, there are a few fly-by-night supplement companies selling instant weight loss cures and cancer remedies that turn out to be useless at best. And predatory or dangerous at worst.
But the FDA already has the authority to go after them! The FDA should pursue them with vigor and bring them to justice!
Why seek new authority?
With this new NDI rule, the FDA is hurting you, the consumer. And they are hurting all the legitimate businesses that sell safe and effective products.
In an interview with an online nutrition magazine, NutraIngredients, Daniel Fabricant, the official behind all this, indicated that this regulation is virtually a foregone conclusion and says, ‘No surprise here, you already have the data required to prove your product’s safety and efficacy,’ to the dietary supplement manufacturers.
In other words, ‘What’s the big deal?’
WHAT’S THE BIG DEAL??
The big deal is that this hurtful regulation could outlaw products you’ve been relying on for your health.
The big deal is that 8 out of 10 applications for NDIs have been rejected by the FDA.
The big deal is that this could be so costly that many good companies will go out of business.
The big deal is that your supplements will cost more.
The big deal is that the two winners out of this are pharmaceutical and insurance companies. Oh, and the lawyers too.
The big deal is that NDIs will ‘clog the system’ and possibly hurt FDA’s focus on food safety.
THAT’S the big deal.
The cynical reality: this is an over-reaching of FDA’s authority.
This could severely hurt your health and well being.
Six things can you do to stop this!
- Write to your Congressperson. Call the congressional switchboard toll-free at 1-877-762-8762. They will connect you with your Representative’s office. Tell them that you are opposed to the new NDI Draft Guidance.
- Write to your Senator.
- Speak directly to the government. Share your comments here.
- Call the FDA Office of Nutrition, Labeling and Dietary Supplements at 1-888-723-3366 and express your outrage.
- Share your thoughts on Senator Roy Blunt’s Facebook page. He’s the ranking member of the Agriculture Appropriations Subcommittee, the group that decides the FDA’s budget. By the way, they just increased the FDA’s budget by $50 million, while most other agencies are facing cuts.
- Send a letter to the President’s Office of Management and Budget. State that FDA’s new guidelines conflict with an Executive Order issued July 11, 2011 that orders the FDA to repeal burdensome regulations that interfere with job creation, economic growth, and innovation.
The FDA recently increased the comment period for this draft guidance by 60 days, to December 2, 2011.