May
Last week, prompted by a mention on a Cropwatch missive, I posted inquiring about the Global Harmonization Act for 2008, and could not find the legislative information or actual verbiage of the act anywhere, except for one small snipped saying I could find it on a website (I couldn’t) and that I could write a certain address with an SASE - however, given the nature of legislative acts in the United States, I assume I couldn’t afford the postage let alone the truck to haul all the paperwork. I even contacted my city/county library, and the reference librarian pulled in a government documents specialist - and this was what they could tell me:
“What I did find was information on the Global Harmonization Task Force GHTF formed in 1992. U.S. Canada, the European Union, Japan and Australia were founding members. Its objective is: ‘to encourage convergence at the global level of regulatory systems of medical devices to facilitate trade while preserving the right of Participating members to address the protection of public health by regulatory means condsidered most suitable.’ There is a notice in the February 6, 2007 issue of the Federal Register vol.72, no. 24 concerning the recommendations of 3 of 5 study groups with the GHTF. Group 4 issued: ‘Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers.’ None of the findings, guidances, or audits constitute mandatory regulations or laws.”
Shortly after starting this search, one of my guild members pointed me to this link talking about a hearing regarding new FDA Regulations. While the article does not say so explicitly it does seem to be related to this Harmonization Act, and also related to addressing the chronically understaffed and underresourced issues of the FDA. It also mentions that should the legislation pass as it is all cosmetics businesses would be required to pay a fee of $2000 in order to sell their products. This, much like IFRA’s attempt to ban nearly all naturals in perfumery last year, is nothing more and nothing less than an attempt to weed out micro-competitors like myself in order to protect their failing corporate profit models. Instead of addressing their internal problems by spanking greedy board members as needed, they are trying to shut down businesses that ultimately have no bearing on their own customer base - the people that buy from the small sellers wouldn’t buy from the big names to begin with, something they’d know if they did any genuine market research.
Some large corporations taking advantage of another big problem that the US in particular has, and trying to ride out a need cut to competition under the guise of law - unless the smaller sellers get it across that this is actually a violation of anti-trust regulations in the U.S. I’m certainly not opposed to regulated consumer safety, but this recommended fee is very clearly not about that.
I fully intend to write all my legislators about this, but before I do, I need the full information. If anyone can point me to it, please do!
If someone knows where I could find it, please, point me to it!
