This is a double edged sword. They make laws like this to give absolute power to a government agency without appearing to be actually doing just that. The upside to this is that consumers will have their dietary supplements regulated, which makes them guaranteed the safest product. Is there a single instance that brought this about? I'm sure tainted dog food and toothpaste within the last couple of months didn't help, but there's no direction to wholeheartedly point the finger at. Honestly, small companies will disappear, product prices will increase, proprietary blend products will be gone, and "Big Pharma" is going to have the last laugh. Those of you who think this is all gravy will be singing a different tune very shortly.
It will effect the companies (larger contract manufacturers) with over 500 employees the most- there was a plant in Fort Mill, SC that did contract manufacture that voluntarily shut down last week- they could not afford to implement all the changes required in the allotted August 2007 time frame- so they closed their entire East Coast operation.
How will AN adapt? Pretty easily, actually- the law really changes very little for us, since we do everything by the book anyways AN is in the process of getting ISO and cGMP certifications (and will have the certification in the alotted FDA-mandated time frame), and strictly adheres to all GMPs- it is actually easier to stick to GMPs in a smaller operation, for the following reasons:
1. The chain of custody of raw and finished goods is much shorter- a lot of mistakes and issues can arise from this in itself
2. You can hand-pick your own suppliers of raw materials and develop business relationships personally instead of through said contract manufacturer
3. Process documentation is much easier to keep track of, because you are seeing how each process is implemented, and how it applies to the products of our company
4. You control and write your own SOPs and Quality Assurance Manual, and I (as the QAP) am in charge of dictating all these processes to employees (HUGE). These are tailored the needs of AN and our customers, and how we can bring you, the consumer, a safer, more effective product (not 50-100 other companies)- this makes for better quality control, process documentation, employee training, and employee awareness of cGMPs...
5. Most importantly, we reserve the ability to bring AN customers THE VERY BEST extracts and products, because we are not paying a contract manufacturer extra $$$ to make our products for us.
Products that would cost most companies an arm and a leg to bring to market and would not be cost effective ARE cost effective to AN, and this allows us to bring out the most effective products on the market, and we pass these savings on to our customers. We roll the money we save back into two things: better equipment and better ingredients/extracts. The result: RPM, IGF-2, NeoVar and the rest of our product line!!!
We are in this game to be a profitable company, just like everyone else, but we (ME especially) take a LARGE amount of pride in what I manufacture, and it is reflected in all of AN's products!!!
6. The same people are making YOUR products day-in and day-out w/ the same formulations and processes (not the products of 50-100 different companies- this is where mistakes really come into play). This also prevents cross-contamination issues....
7. You can design your own manufacturing facility, and taking into account FDA/cGMP guidelines, tailor it to the needs of your company and customers.
8. We have a 700 square-foot in-house manufacturing facility that is strictly humidity-controlled (less than 25% at all times), air quality-controlled (air flitration down to 0.5 microns), and temperature-controlled (78 F at all times). The facility is complete with separate linear rooms for mixing, encapsulation, and bottling. We based the design of this facility off of FDA/cGMP guidelines- we know exactly what was expected of us when we built the facility, and did not deviate from it.
9. Direct product sampling/lot retention/batch management is MUCH easier, and required testing can occur within a day because we keep all lot and batch records in-house. Stability testing is easier for this reason as well- we know EXACTLY when someone was made, not a general idea, and we have all of the COAs and refs to back it up....
10. We have the ability to formulate, research, and test numerous different supplement combinations in a controlled environment- we have 100 different types of raw materials in our warehouse, and AN is constantly researching ways to make our products better, and how to make more effective combinations/blends.
11. We clearly list all product components of our blends on the label, and this is strictly adhered to- we don't make up names for novel components, and won't produce anything that has not been deemed safe and effective by research- in a smaller operation run by honest people, this is a very easy process to adhere to.
Just because we are small does not mean we are not highly organized- hell, ask Outside Backer or Buffhunk- they have both seen our entire operation
Dirk plagiarized this answer telepathically from my mind.
Applied Nutriceuticals Representative Better Results Through Science Success occurs when everything you have is APPLIED.
Have you heard about N.O. Uptake? ;-)