- Joined
- Jun 12, 2003
- Messages
- 4,665
Dante:
I agree with you on all points. Many people do not realize the supplement industry is like the wild west. The companies with the highest revenue typically have three actual skill sets (note that none of them have to do with supplements):
1) Ability to raise the most amount of capital (largest marketing budget)
2) Have successfully hired the best marketing staff
3) Have a formula for the highest MER Ratio (ROI) on their advertising campaigns
-What is your opinion on GMP Certified/FDA Approved manufacturers?
-Do you believe the standards set by both of the organizations are high enough? Or are the certifications mostly BS marketing?
-Would you eliminate "Proprietary Blends" or see value in it to protect trade secrets?
-Would you be for higher FDA regulation requiring all supplement companies to only sell products produced in FDA approved facilities?
-Many of the points brought up in CFR 111 are vague, non specific and pointless. I was under the impression the FDA mostly red flagged individuals for false promises on labels. Are you seeing an increase in FDA investigations. Do you believe the FDA is making progress in this direction or really failing to properly regulate/forgetting about health supplements and focusing mostly on food?
1) I think its a ploy for money to be honest with you. NSF or these other certifiers come in and charge you 22 thousand to 35 thousand a year to be "Certified"...when the FDA and the certifiers have nothing to do with each other and companies end up with writeups and 483 letters anyway... NSF responds to Beehive Botanicals warning letter situation ...so you pay all this money for supposed peace of mind and in the grand scheme of things...NOBODY gives two clucks if you are NSF certified anyway. The consumer doesnt and the companys you make products for dont. In 13 years of making products for companys ive been asked a total of once if we were NSF certified and when I said we didnt go that route because of a neighboring manufacturer's opinion (wasnt good) on being NSF certified, they didnt care anyway. So getting NSF or other certified seems to do one thing....raises your prices on manufacturing so you make even less profit and/or lose out to other companies who give lower manufacturing costs....and in some cases ending up with a 483 letter anyway
2) Bullshit marketing....and again nobody cares about it (certainly the FDA doesnt)...we are friends with one of the largest fish oil manufacturers in the world...he goes NSF and gets writeups anyway and FDA scrutiny...so his 22-35k does nothing except raise his production costs
3) I used to be so against proprietary blends until a certain point....and then I saw so much copycatting in the industry that there is no other way for a company that makes a damn good product to keep from their product from being copycatted. How does a company who makes a great product keep their product from being copied and exploited by another company who makes it with crappy ingredients and subpar materials but copies it mg for mg and convinces customers to buy that crap version?
-Would you be for higher FDA regulation requiring all supplement companies to only sell products produced in FDA approved facilities?
I dont know any legitimate manufacturing companies who arent under FDA regulation. I keep hearing people say the industry isnt regulated and i have no idea where that comes from. Anyone who has a certain threshold of sales is going to be visited by the FDA and scrutinized thoroughly (both their facility and their paperwork) and sometimes its a 4-7 day process thats intense. The only people i see not under regulation from the FDA are small time scammers who are making supplements in their basement or kitchen or garage and havent gotten in the FDA's radar yet. Thats why you see these companies pop up and then disappear pop up and disappear, they probably got an FDA visit, and were found out they were packaging up stuff in their basement and not a facility and the FDA shut them down. The large manufacturing companies....they are legit and are following the rules (testing/potency/identity/purity) facility and all paperwork
-Many of the points brought up in CFR 111 are vague, non specific and pointless. I was under the impression the FDA mostly red flagged individuals for false promises on labels. Are you seeing an increase in FDA investigations. Do you believe the FDA is making progress in this direction or really failing to properly regulate/forgetting about health supplements and focusing mostly on food?
They come in and ask for usually 2-4 fully stacked paperwork batch record folders on your most recent productions/popular products....the 3rd party testing must match the COA but if you are only a supplement company (who doesnt make their own products), you have to have testing matching your manufacturers testing which matches the sources COA. FDA usually comes in every single year, sometimes 2x a year , sometimes every 2 years....again I saw one of my FDA agents schedule one year....she had every single supplement company I knew of in a 50 mile radius on her docket....the only ones not getting visited are "underground garage scammers"....In my opinion...the FDA is scrutinizing pretty darn thoroughly...its the flat out scammers who are giving the industry a bad name. In every industry there are going to be people trying their best to scam the system...and these bathtub brew startup companies who arent on the radar yet...give everyone bad publicity when they finally get discovered. As far as the major names getting raked over the coal because they have subpar testing results? Again virtually all supplement companies dont make their own supplements....99.5% of them dont. So that leaves .05% custom manufacturing companies....and again in every incredible bushfull of apples there is a bad one....and for whatever reason certain manufacturers are doctoring paperwork or scamming to get the manufacturing business. The whole amino acid adding scam came about because of money. Manufacturing is done on volume...and to get the contract you have to have the lowest prices so....some slimeball manufacturer didnt want to have a 86 million a year in sales supplement company turn way from him because of too high prices...so he amino spiked to win the manufacturing contract....and i believe thats how it started.
I couldnt even tell you how many companies came to me to have us manufacture for them and we gave them legitimate pricing....and they said "thats too high, so and so will make it for this amount" and I say "really? because i cannot even buy the materials, the containors, and everything else for that cost....never mind even making profit!.....and i give them the if it sounds too good to be true speech which ends with "just remember your reputation with your products is what is the legacy of what your company is built on"......<----this exact scenario happened about 4 years back with a company that was involved in the amino spiking scandal.....and i warned him at that time and he went with the lowball too good to be true manufacturer....and he got what he paid for and ruined his rep.
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