3 ms·

cGMP appears to apply to drug manufacturers. This isn't a drug, and isn't being marketed as a drug. It's a food. Similar to the hippie granola bars I mention

by blhack 13y ago

cGMP appears to apply to drug manufacturers. This isn't a drug, and isn't being marketed as a drug. It's a food. Similar to the hippie granola bars I mentioned. edit: are you saying that you have experience in this field? Enlighten me. What are they doing wrong, and how should they remedy it?

atdrummond 13y ago
cGMP applies to all dietary supplements, which is what this will likely be classified as. This same process applies to Abbott Labs [owner of EAS] as well as small entities. Here is the compliance guide for small entities: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm238182.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocuments... As of 2010 all SEs must meet these requirements, regardless of firm size. Re: my experience in this field, it is all indirect - research for those interested in developing products in this area, alongside business partnerships and friendships with those who produce a wide range of dietary supplements. EDIT: I will note that they now claim the product will be produced in a FDA-approved facility. Whether this facility's certification is applicable to their specific case is not made clear but this is at least a step in the right direction. There's also the matter of labeling/ad claims with the FDA but hopefully they have the foresight to dial back the hyperbole before pushing the product to a wider audience. I would also suggest caution with what "industry experts" one works. There's quite a few less-than-desirable elements in the dietary supplement game. Case in point? The lacing of the Craze/Detonate pre-workout supplements with amphetamines just a few months ago. (http://patrickarnoldblog.com/craziness-over-craze/ http://patrickarnoldblog.com/craziness-over-craze/)

3 ms·

cGMP appears to apply to drug manufacturers. This isn't a drug, and isn't being marketed as a drug. It's a food. Similar to the hippie granola bars I mention

by blhack 13y ago

atdrummond 13y ago
cGMP applies to all dietary supplements, which is what this will likely be classified as. This same process applies to Abbott Labs [owner of EAS] as well as small entities. Here is the compliance guide for small entities: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm238182.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocuments... As of 2010 all SEs must meet these requirements, regardless of firm size. Re: my experience in this field, it is all indirect - research for those interested in developing products in this area, alongside business partnerships and friendships with those who produce a wide range of dietary supplements. EDIT: I will note that they now claim the product will be produced in a FDA-approved facility. Whether this facility's certification is applicable to their specific case is not made clear but this is at least a step in the right direction. There's also the matter of labeling/ad claims with the FDA but hopefully they have the foresight to dial back the hyperbole before pushing the product to a wider audience. I would also suggest caution with what "industry experts" one works. There's quite a few less-than-desirable elements in the dietary supplement game. Case in point? The lacing of the Craze/Detonate pre-workout supplements with amphetamines just a few months ago. (http://patrickarnoldblog.com/craziness-over-craze/ http://patrickarnoldblog.com/craziness-over-craze/)