Warning: Your access to dietary supplements is in jeopardy
How to protect your health freedom in 2012 and beyond
If you’re reading this right now, chances are you have at least one dietary supplement in your medicine cabinet. Maybe it’s omega-3s to support heart health, or zinc to fight off that cold, or vitamin D to help protect against, well, just about everything. Maybe it’s one of my own Real Advantage Nutrients formulas, like GlucoComplete to help you maintain healthy blood sugar.
Whatever your favorites are, do yourself a favor and stock up now——because if the FDA has its way, they won’t be available much longer.
The FDA has put together a draft of guidelines for the new dietary ingredient protocols, and if this draft becomes law…
It would be like dropping an A-bomb on the supplement industry
Poof! Just like that, an entire industry could be gone overnight.
Get ready for a bunch of acronyms, but stay with me. This is important. All supplements on the market must comply with the Dietary Supplement Health and Education Act (DSHEA). Part of DSHEA includes the New Dietary Ingredient (NDI) notification protocols. Ever since DSHEA was enacted in 1994, the NDI protocols have been vague, to say the least. And the government enforcement has been inconsistent, at best. (So what else is new, right?)
Now, 17 years later, the FDA has decided to define the guidelines for the NDI notification protocols, and what they’re proposing could spell the end of nutritional supplements.
With these new guidelines, what began as merely a “notification” process under DSHEA would quickly turn into an “approval” process that was never the original intent of DSHEA’s New Dietary Ingredient protocols. What a nightmare!
I can’t stress to you enough the dangers these new “approval” guidelines pose. Under these new rules, the FDA could outlaw the sale of new supplements based on… well, based on nothing at all.
This doesn’t just place in danger supplements that haven’t been created yet——it affects any supplement developed after 1994 (the year DSHEA was passed).
Here are just a few of the points of the new draft guidance:
? Any ingredient not absolutely identical to how it was before 1994 must be approved.
? NDI notification is based on each manufacturer, and not on each ingredient. So even if multiple companies were manufacturing the same ingredient at the same quantity, each company would have to submit a separate notification for approval.
? A new NDI notification must be made each time a different amount of an ingredient is used, or any time that ingredient is used in combination with separate ingredients.
? Although the FDA has 75 days to acknowledge receiving a new NDI application, they have no deadline for approving them.
The FDA can’t even keep up with its workload as it is! Not only would these regulations set the FDA up for failure——they’d doom the supplement industry to die in a mountain of paperwork and red tape. The result would be the non-approval of completely safe and extremely effective supplements——simply because there aren’t enough lemmings in place to push them through.
These new guidelines could easily cause your access to life-saving supplements to disappear overnight
In the meantime, drug companies can work toward patenting common dietary ingredients. Once an ingredient has been studied and published by a drug company, it can no longer be used in supplements. And you know what that means…you’ll be getting the same thing——but at ten times the price.
These guidelines would require natural supplements to adhere to the same testing and approval methods as pharmaceutical drugs. The kicker is that this is impossible for nutritional supplements——and the FDA knows it. Supplements are made of substances that exist in nature, so they can’t be patented. And if a substance isn’t patented, it’s impossible to be able to afford to pay for the drug approval process.
As usual, the standard justification for these new rules is “consumer safety.” Give me a break! If they care so much about consumer safety, they’d scrap the entire pharmaceutical drug industry and start from scratch. Instead, your government backs the very industry that is responsible for 80 percent of poison–related fatalities. Consumer safety my right foot. That’s like appointing a fox to guard the henhouse and then blaming the pet rabbit for a few missing chickens.
By the way, according to the U.S. National Poison Data System, do you know what percent of poison-related fatalities were caused by nutritional supplements? ZERO.
The bottom line is that these new draft guidelines are unnecessary, unreasonable, and unacceptable. And besides that, they would place already overburdened FDA under an impossible strain.
For now, keep stocking up on your favorite supplements. And you can be sure I’ll keep you posted on this important issue in the months to come.