The FDA and Your Business -- Good and Bad

Picture this: you head to your local pharmacy to pick up a prescription from your doctor. When you get the bottle from the pharmacist, there's a message somewhere on it: "FDA Approved." That means the FDA -- the US Food and Drug Administration -- has given your medicine the "green light." Ostensibly, this stuff is safe to consume, and will actually do what it says it does.

But what if the bottle doesn't have an FDA mark? In fact, what if -- as is the case with every herbal supplement you'll find in a grocery store, drug store, or your Gano Excel affiliate -- there's a notice specifically saying, "These statements have NOT been evaluated by the Food and Drug Administration." What would you do then?

Way back in 1994, Congress required the FDA to set manufacturing standards for all dietary and herbal supplements. Now, our buddies at the FDA don't prevent the production or selling of untested supplements -- but they do place strict limits on advertising. (This is where the "...and your business" part starts!) Companies that produce supplements cannot make specific claims about the how their products can treat, prevent or cure any diseases, even if they really can treat, prevent or cure a disease. They aren't even allowed to claim any direct health benefits; they can only allude to them. The FDA deems anything that can treat, prevent or cure diseases is a drug, and must go through the lengthy and expensive drug approval process.

And let us tell you, that can take a loooong time. A company that develops a drug for human consumption must first be able to prove scientifically that the drug is safe (mainly through animal testing -- you know, all those poor monkeys, rabbits, and lab mice). Then, the drug has to get FDA approval to begin tests in humans. From there it's progress reports, risk assessments, all that jazz -- and sometimes, even after all that, stuff gets buried or confused. For instance, some people saw links between antidepressant Prozac and an elevated risk of suicide in teenagers -- but the drug was still on the market, even as our children were at risk. (Click here to read a BBC article on the subject.)

This testing process can cost millions of dollars, leaving most supplement companies unable to even dream of filing their product as a drug.

 Although this policy aims to prevent supplement companies from making false or misleading claims, it can also prevent consumers from easily identifying potential health benefits from truly effective supplements. As a result, many consumers are not aware of the many commercially available supplements that can treat their medical conditions cheaply and safely, unless supplements are prescribed by their doctor. This whole thing seems a bit ridiculous.

In a perfect world, supplement manufacturers would be able to discuss more clearly just what their products can do. However, the reality is that many companies are willing to promise more than they can deliver, and as such, FDA standards serve an important “watchdog” function. By following FDA policies, Gano Excel is unable to get the message out to consumers of the potential of their ganoderma-infused products to treat, prevent or cure many diseases. Instead we can merely state that the products promote good health. Yet customers who have had remarkable health results can’t help but tell others and by word of mouth, the amazing power of the Gano Excel products is told.

But let’s be clear: we here at Gano Excel understand and believe that the FDA does serve a vital role in protecting the people of the United States. The FDA ensures that supplement products are free from pesticides, microbes, and metals. The FDA also polices the industry to ensure truth in labeling, which means that the ingredients listed on the supplement label match the ingredients of the product. The FDA testing and labeling restrictions have been put in place to ensure safety for consumers, through rigid standards of testing, advertising, and product approval. The FDA is designed to not only approve products but also to ensure that no false guarantees are promised in advertising.

Gano Excel adheres to FDA regulations faithfully, and follows the guiding principles of the FDA. Gano Excel has maintained a Good Manufacturing Practices certification which actually exceeds the health and safety standards of the FDA. Gano Excel also welcomes (and actively invites) the scrutiny of their operations by their customers, as they are backed by an impressive health and safety record.

Want to find out more about the FDA and your business? Check out these informative links:

--http://www.jonbarron.org/blog_published/2007/04/fda_labeling_guidelines.html

 

--http://meddesktop.blogspot.com/2008/08/dietary-supplements-101-form-fda.html

Comments

[Joshwa Wolf]

It is safe to say that Gano Excel exceeds the expectations of the FDA and still goes through the brutal inspection process as new shipments are sent into the US.

Rather than making claims our products cure, heal etc.... State that the Ganoderma has all these added benefits which can be reviewed on pubmed.gov putting the spot light on the #1 herb in the world with documented research, then simply stating our product just has ganoderma in it.. as Mike Marumoto states...

I always tell people we are 100% FDA inspected not approved but hold the highest standards of the FDA and maintain the "Good manufacturing practices certificate".

We have an amazing product here folks and Gano Corp is here to help ensure that we are around for a long time running which ensure's that our businesses will be able to flourish in the years to come.