While most of you are aware of these facts published by FDA last week, I found this article quite interesting, and it may teach us a thing or two!  And because many of our readers come from different backgrounds than us in regulatory, the FDA, or the healthcare industry, it may provide some prospective on the different categories of products that the FDA is charged with regulating.  Remember, while the FDA may regulate a lot of product types, not all of these products are FDA approved. 

Fact #1: Generic medicines work the same as brand-name medicines. 

While some would challenge this on an individual product basis, this FDA fact is overwhelmingly true. 

Fact #2: Vitamins, minerals, herbs, and other dietary supplements are NOT FDA approved to treat or prevent disease. 

This is an area where the FDA is looking for additional statutory authority.  I have written numerous blog posts about problems with firms marketing products that do not meet the definition of dietary supplements or, if they do, firms may make unlawful or unsubstantiated claims about their products intended uses. 

Fact #4: The FDA hasn’t approved an e-cigarette as an aid to quit smoking. 

Fact #5: The FDA doesn’t approve facilities. 

This is 100% correct! The FDA may indicate that a firm is in compliance with current good manufacturing practices at a given time and, thus, acceptable for the manufacture of drugs, devices, or biological products, as testing labs, or the like, **but** the FDA does not approve facilities so, if you see a statement that a particular facility is approved, it is wrong.

Fact #6: There’s no such thing as waterproof sunscreen. 

How many times have you seen sunscreens labeled as waterproof?  I saw one just last week.  Sunscreen can be water resistant, but they are not waterproof.  According to the FDA fact sheet, “[E]ven those labeled ‘water resistant,’ eventually wash off.  Water resistance claims, for 40 or 80 minutes, tell you how much time you can expect to get protection while moving in and out of the water.” 

Fact #7: The FDA does not approve cosmetics. 

The FDA is looking for more statutory authority to regulate this class of products as well.  The concern comes from additional adverse events being reported for cosmetics and the use of ingredients that are not currently acceptable for use in cosmetics. 

Fact #8: FDA-approved vaccines have undergone a rigorous evaluation by the FDA to ensure their safety and effectiveness.  Bonus fact:  There is no link between vaccines and autism, as has been shown with scientific rigor in multiple studies. 

Fact #9: Using CBD raises safety concerns, and some CBD products are being sold with unproven claims saying they can treat or prevent diseases or conditions. 

This is yet another burgeoning industry that is basically under-regulated, and the widespread use and proliferation of CBD products over the past few years have taken the FDA somewhat by surprise.  Again, the FDA is studying how to best regulate these products to protect the public, and this is another area where the Agency is looking for additional regulatory authority to do so. 

Fact #10: The FDA is responsible for protecting the public’s health. 

I hope you find these facts interesting and helpful.  Fact #10 is all encompassing regarding the FDA’s daily push to further protect the public from products that are illegal, dangerous, contain undeclared drugs, or are labeled with claims that are unsubstantiated or not proven through proper regulatory channels.