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FDA Approved????

I hear things.

And some of them can really be exasperating.  How many times has someone told you that they are an FDA approved lab or that all of their products are FDA approved?  Probably quite a few.  And probably a lie.  Maybe not intentional, sometimes non-technical people misinterpret the meaning of certain things.

Let’s set this issue to rest.  Brought to you directly from the FDA website (www.fda.gov) is the following list:

The FDA does NOT approve: Companies, compound drugs from pharmacies, cosmetics, medical foods, infant formula, dietary supplements, food labels including Nutrition Facts, structure-function claims on dietary supplements and other foods.

The FDA does approve: New drugs and biologics, medical devices (risk-based tier system we’ll discuss further down), additives in food for people, drugs and additives in food for animals, color additives used in FDA-regulated products.

That’s it!  There is no FDA-approved cosmetic.  We are not an FDA-approved laboratory or manufacturer.  We are an FDA registered facility.  That means that the FDA knows where we are, knows what we are manufacturing and can drop in to inspect us at any time.  (We are also registered with the State of California Department of Public Health, Food and Drug Branch.  They inspect us too!)

Time to take a look at a couple of the items mentioned above:

1) Medical devices – OK, you may wonder how this category affects you.  But it is very relevant.  Condoms, personal lubricants, cock rings, clitoral engorgement items are all medical devices!  Cock rings are in the lowest risk category and the FDA allows their sale without pre-market approval providing that they have the same use and are of the same technology of what is already on the market.  They also need the appropriate instructions and warnings in the language provided by the FDA.

Personal lubricants and condoms are Class II medical devices.  They can be cleared for marketing based on an FDA determination that they are substantially equivalent to an already marketed device of the same type.  This requires a lot of testing and expense by the manufacturing company.  And upon that determination, the product is granted a 510(k) number.   In case you were going to ask, if your new product does not strongly resemble one already on the market, you have to complete a NDA (New Drug Application.)

High risk medical devices like a mechanical heart valve require FDA approval after what can be years of testing and review.

2) Color additives for FDA regulated products.  Those would be all Foods, drugs and cosmetics.  The US works on a positive list.  If the colorant is listed for your particular application, you can use it.  If it is not on the list, no way.

3) Dietary supplements.  If someone offers you a vitamin pill, energy shot, “enhancement” pill and claims they are FDA approved, run away!  The FDA requires the following statement: “This product has not been reviewed by the FDA and is not intended to diagnose, treat, cure or prevent any disease.”  And if it did, that dietary supplement would be a prescription drug.

So what have we learned today?  The FDA does not approve companies or bunches of products.  Since they don’t approve them, do we have to follow their rules?  You betcha!  Our products are regulated, but not necessarily approved.  There are many things that I haven’t touched on here.  Ask me!

Ask questions!  Question authority!

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