Well it finally happened. Just when I thought the FDA singled me out for selling BULK powders, yesterday the FDA issued warning letters to a bunch of bulk supplement companies. Essentially the warning letters are a chance for the companies to correct their violations before the FDA seeks legal action to stop the companies from doing business. These companies have 15 days to respond to what actions they are going to take to comply with the CFR 111’s. Too bad it wont do them any good. Let me explain why…
First for the record these companies that I’m going to talk about may very well be following the CFR 111’s to the “T”. They might have the best quality control practices in the world. BUT…because I am well versed in the CFR 111’s for dietary supplements I can tell you in my opinion and it’s my guess that their is no way that these companies are compliant with the CFR 111’s to begin with. Each one of these companies sells BULK supplements which require tons and tons and tons of paperwork in order to be compliant with the CFR 111’s. It is literally impossible to sell products in such a way and be compliant with the regulations. That is why my company had to stop selling bulk supplements. It was impossible to sell supplements this way and remain compliant.
Let me show you what I mean. Take a look at how many powders SMART POWDERS has
They have 116 products bulked packaged. And out of those 116 product many of them you have the option to buy different sizes. I would guess in total about almost 200 different products. Now according to the FDA regulations 111’s for dietary supplements you need a BOAT LOAD of documents. You need a boatload of lab tests. Every single one of these supplements that Smart Powders is selling on their site must be tested for strength, composition, and purity. FOR EVERY SINGLE BATCH MANUFACTURED. You need master manufacturing records and batch product records. You need lab certifications and lab analysis. And that is just scratching the surface. There are just too many powders in this companies inventory for me to believe that they have all the paperwork to satisfy the 111’s for each and every product and each and every batch. That is what happened to my company. We would sell bulk supplements. A customer would order a certain amount and we would pack it up and ship it out. YOU CANNOT SELL supplements like this and follow the 111’s. It is impossible!! That is why I had to stop selling bulk.
These companies that the FDA served warning letters to are going to have to stop selling their “bulk supplements” because physically and financially it is impossible to follow the governments regulations for dietary supplements. Hey more power to them if they can. Personally I couldnt find anyway to do it so I stopped selling bulk. I’d rather keep my business then have a judge shut me down.
Now here is the part in the warning letter that is really important.
This means ALL of their products must comply with ALL of the regulations. Meaning the FDA wants ALL their products compliant, not just the caffeine. So that creatine that they are selling…yea they better have a MMR, BPR, lab certs, SOP manual, testing, and all the other 10,000 documents required for every single product that they are selling.
For a while there I was that guy that the police pulled over for speeding while everyone else is flying by on the freeway doing 100mph and I’M the guy getting the ticket. Well now everyone else is getting the speeding ticket, not just me. It’s about time!
Here are the warning letters if you want to see them.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm460203.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm460201.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm460204.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm460208.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm460200.htm
Alex Rogers is a supplement manufacturing expert. He has been formulating, consulting, & manufacturing dietary supplements since 1998. Alex invented protein customization in 1998 & was the first company to allow consumers to create their own protein blends. He helped create the first supplement to contain natural follistatin, invented whey protein with egg lecithin, & recently imported the world’s first 100% hydrolyzed whey.
