The Supplement Crack-Down Has Crossed the Atlantic

Date: 01/11/11

Nutritional supplements are under siege! Despite their impeccable safety record, the FDA has issued new rules — called The New Dietary Ingredients. These stringent regulations will see to it that some of the most effective nutrients, like resveratrol, CoQ10 ubiquinol… bacopa… strontium… and many more, will be pulled from the market… supplements and natural remedies will be regulated and tested like they were pharmaceuticals! 

We’ve seen it happen in the UK and the rest of Europe, and now it appears these draconian measures are crossing the Atlantic… nutritional supplements are under siege!

This alert is extremely important, especially for our US readers. So, I’m asking you, before I start, to forward this email to everyone you know (especially any friends you have in the US), after you’ve finished reading it.
Banned in the US… Banned worldwide

Let’s look at some key facts first: 

  • Pathogens like E. coli in food kill at least 2,000 people each year
  • Acetaminophen in drugs like Tylenol kills 450 people every year
  • The prescription drug Vioxx likely killed over 26,000 people before the American Food and Drug Administration (FDA) finally took it off the market!

Statistically supplements are much safer than prescription drugs, cosmetics, medical devices, and even food! Unlike pharmaceuticals, according to the US Poison Control Centres, there were zero deaths due to supplements in 2008. In 2009, there was one. Need I add that millions of people have benefitted from taking supplements? They’ve found relief from joint pain… protected their hearts and arteries… boosted their memory… and much more. Most supplements are also side-effect free.

Despite their impeccable safety record, the FDA has issued new rules — called The New Dietary Ingredients. These stringent regulations will see to it that some of the most effective nutrients, like resveratrol, CoQ10 ubiquinol… bacopa… strontium… and many more, will be pulled from the market… supplements and natural remedies will be regulated and tested like they were pharmaceuticals!
Back with a vengeance

In the early 1990s, the FDA tried a similar stunt. In a massive revolt, alarmed consumers managed to stop the FDA’s bullying and the US Congress passed the Dietary Supplement Health and Education Act (DSHEA) — a law that protected supplements from the FDA unless they could prove a supplement wasn’t safe. For 17 years, the FDA took no action, gave no guidance, and launched no enforcement. The dietary supplement industry was safe and flourished, and came forward with tremendous innovations.

BUT… and there’s always a but… There was a loophole in the DSHEA: The FDA still had the authority to regulate new ingredients introduced after 15 October 1994… Now, the time has come for the FDA to hit back with a vengeance… After 17 years of doing nothing!

Under the proposed guidelines, the FDA can define almost anything as a “new” dietary ingredient. For example:

  • Let’s say a supplement includes more of an ingredient than was used 17 years ago — even something like vitamin C — it’s “new.”
  • If an ingredient uses a different extraction process — like baking or fermentation — it’s “new.”
  • If a supplement uses an ingredient at a different “life stage” — such as using ripe rather than non-ripe apples — it’s “new.”

The list of ludicrous regulations goes on and on… If a supplement is regarded as a “new” ingredient, manufacturers will have to remove it from store shelves until they can prove the ingredients are safe — even if those ingredients have been used safely for the past 17 years!

This is nothing short of a blatant and vindictive abuse of power! Not only is the FDA making it near impossible for manufactures to comply with these regulations, but it’s also an underhand tactic to slowly suffocate the supplement industry.

Firstly, the cost of a one year study (a requirement under the new rules), comes to round about $100,000-$200,000 per study, per ingredient — a product with six ingredients will effectively cost $3.6 and $7.2 million to test. Secondly, many companies would have to conduct animal studies using a dosage that’s 1,000 times the typical dose… to prove that it’s safe! So, animals will be force-fed the human equivalent of 240,000 milligrams of a particular ingredient each and every day. This will almost certainly harm them. Voila! The FDA would then have their reason to outlaw the product… If only dangerous and side-effect ridden drugs like statins were tested under the same guidelines, the world would be a much safer and better place!

These measures mean that most of the nutrients you buy today will be pulled from the market and never return. Those that do return will be a lot more expensive — or may only be available as prescription drugs!
First, we conquer Europe…

The FDA is clearly following suit with what has happened across Europe. In April 2011, the European Food Safety Authority (EFSA) implemented the Traditional Herbal Medicinal Products Directive (THMPD). The THMPD is similar to the New Dietary Ingredients and has had a massive impact on the supplement industry. Our health food stores are running empty over here and when you eventually manage to lay your hands on a high quality supplement, it costs an arm and a leg.

But there is still hope for the US. The FDA’s proposed guidelines have not yet been finalized. The public still has the opportunity to comment on this draft before it is made final. In this case, the public has until December 1st to comment on the draft. It’s a small window of opportunity but you can still voice your disapproval.
I’ll repeat that date: 1 December 2011!

The best way to defeat the New Dietary Ingredients is to talk to the people you’ve elected — your congressman and your two US senators. They have the power to reign in the FDA — and they have done so in the past when enough voters complained. So, make your voice heard.

Here’s what you need to do:

Go to this website and look up the phone numbers of your US Senators and your Representative (congressman). Then give them a call… here’s some pointers of

What to say:

  • Hello, my name is [name] and I am a constituent of [name of Senator or Representative].
  • I am very concerned about the new FDA draft guidance on dietary supplements and new dietary ingredients.
  • Feel free to tell them about the supplements you take and/or the benefits you get from those supplements. Then feel free to make as many of the following points as you like:

1. Supplements have an unrivaled safety record. Statistics show they’re safer than drugs, safer than medical devices, safer than cosmetics, and even safer than food.

2. The FDA cannot define New Dietary Ingredients so broadly. According to these guidelines, almost everything is a New Dietary Ingredient. This will strangle innovation and deprive consumers of the supplements they depend on for their health.

3. The FDA did nothing about new dietary ingredients for 17 years. Now they want to wipe out 17 years’ worth of innovation and 17 years’ worth of benefits to the consumer.

4. When the Dietary Health Supplement Education Act was passed, Congress intended a simple notification process for new dietary ingredients. The FDA is turning this into a pre-approval scheme, which goes against the intent of the law.

5. The FDA already has ample regulatory authority to take action against a product if it’s unsafe. They don’t need to have this pre-approval power, too.

6. These could be disastrous to public health. At a time when preventative measures are even more important to health care costs, the FDA is limiting access to preventative health care.

7. The cost of complying with these guidelines would be astronomical. Experts estimate that the studies required would cost between $100,000 and $200,000 per ingredient notification. That adds up to millions of dollars per supplement company. Smaller companies would not be able to afford this and would go out of business.

8. The economy is already hurting and we have high unemployment. Experts estimate that this could cost the economy tens of billions of dollars and result in the loss of tens of thousands of jobs.

9.  The government’s resources are already stretched. We have record budget deficits and record debt. Why enact more regulations when there are no safety issues here?

  • I request that Congress direct the FDA to carefully review their draft guidance. If they do not amend the guidance to reflect my concerns, I request that Congress call hearings at the end of the review process. I also call on Congress to write legislation that would “grandfather” all supplements currently on the market.
  • Thank you for your time.

Remember, the job of those answering the phone is to listen politely and to relay what you say to their boss. So please do call. Don’t be shy.

After the phone call, send a letter to your senators and reps, making the same points. Make sure the letter is in your own words (form letters tend not to work as well). You can find the e-mail and physical addresses at the same website.
Then send the same letter to President Obama. (His address and phone number are on the website, too.)

Do not make the mistake of thinking that the FDA won’t take your supplements away.

As you’ll know from reading these e-alerts, similar regulations have already been passed in other countries, and the results have been nothing short of disastrous. Many supplements have been banned forever. Don’t let that happen in the US too.


Sources:
‘New Dietary Ingredients in Dietary Supplements – Background for Industry’ published online, www.fda.gov/
‘Legal action against EU’s herbal medicines ban ‘imminent’ published online 23.05.11, nutraingredients.com

Taken from: http://www.thehealthierlife.co.uk/natural-health-articles/news-views/american-food-and-drug-adiministration-supplements-efsa-thmpd-00742.aspx