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The FDA Globalization Act

FDA Regulations

FDA Regulations The FDA Globalization Act, intended to impose stricter safety standards on domestic and imported foods, drugs, medical devises, and cosmetics the proposed legislation indeed seems to offer improved consumer protections – at least, at first glance.

FDA Regulations

If you’ve been hearing the soft hum of dissent when you tune into the internet, it might be emanating from opponents of new legislation proposed by the FDA, commonly known as the FDA Globalization Act. Intended to impose stricter safety standards on domestic and imported foods, drugs, medical devises, and cosmetics (and also to raise money for the strapped organization), the proposed legislation indeed seems to offer improved consumer protections — at least, at first glance.

For instance, the bill calls for bi-annual inspections of foreign manufacturing plants that produce drugs and cosmetics imported into the US. Given the apparent rash of disasters that have resulted from contaminated goods arriving from foreign ports, this provision “seems” reasonable. Currently, only seven percent of foreign manufacturing plants receive annual inspections, and these inspections tend to be substandard since factory owners typically get advance notice, giving them time to put on a show. Such lax regulations have resulted in several high-profile public health fiascos, including the 2006 recall of 183,000 packages of contact lens solution manufactured in China because of bacterial contamination, and the uproar in 2007 over China-manufactured toothpaste containing diethylene glycol, which is a solvent and antifreeze component.

Infrequent inspections also have led to some public health problems domestically. And so, the FDA insists that inspecting plants every two years will lead to higher standards and safer products on the shelves. One provision, for instance, requires packing companies to label meat products that contain carbon monoxide, used to disguise how old and decayed the meat is. Requirements such as these have led groups including the Consumers Union to come out strongly in favor of the bill.

So why is there an outcry against such a “reasonable” bill? For one thing, in order to install the cadres of new inspectors that will be necessary to carry out the work, the bill calls for across-the-board fees that have small, alternative health companies reeling. In fact, all companies covered by the act must pay an annual fee of $2,000 to register with the FDA, and that’s just for starters. While companies such as PepsiCo can swallow that amount easily, it’s a hefty chunk for a small start-up. But if you’re thinking, perhaps, that a company shouldn’t be in business if it can’t afford $2,000 for safety, it gets worse — much worse.

Other fees will be assessed for inspection, re-inspection, certification, certifying agent accreditation, laboratory accreditation, export certification, and importer registration. Any company that uses imported ingredients (think ayurvedic and rainforest herbs) will have to pay an additional annual fee of $10,000. Any violation of the regulations, such as failing to register, would result in substantial fines. And on top of paying the fees, companies would need to fill out extensive amounts of paperwork to prove that they’re complying with the regulations. Since the fees charged to small companies equal those charged to the mega-manufacturers, the small companies would end up underwriting the process for the giants. And, because so many nutritional product companies and manufacturers of alternative beauty products rely on imported ingredients, the costs incurred will, in many cases, become prohibitive. In other words, you can say goodbye to many companies and products that you know and love.

According to the FDA Law Blog, the fees netted from “food registration alone will generate approximately $600 million for food safety activities at FDA.” That may be good news for the FDA (and those on its payroll), but will be a definite death sentence for a number of small manufacturers. At the least, we can expect to see those fees passed along to consumers (that’s you, by the way) in the form of substantially higher prices.

There’s also the issue that under the proposed regulations, nutritional supplements would be classified as food products, meaning that they would be subject to the same review process that food items undergo. Within 24 hours of an inspection, a report would be issued, and if it declared that, “processing controls are inadequate to prevent or minimize food safety hazards or that any food from such facility is unsafe for human consumption, adulterated, or misbranded,” the product would be subject to immediate recall. This language makes it possible for any inspector with a biased attitude to ban alternative products at will, ignoring preexisting legislation such as the Dietary Supplement Health and Education (DSHEA) Act. Is bias against alternative health a problem at the FDA? Silly question! It should also be noted that classifying nutritional supplements as food products would require small manufacturers to follow procedures far more appropriate for the large guys — or else!

Make no mistake. The FDA Globalization Act threatens your access to affordable nutritional products. You might want to review the National Health Foundation’s call to action at http://www.thenhf.com/article.php?id=560. And for those of you living outside the US, you are not unaffected. As the FDA tightens regulations, regulations will tighten in your own country as well. To paraphrase George Bush, you might want to take action and fight these regulations in the US, so you won’t have to fight them in your own country. You too, should check out the NHF’s call to action.

:hc

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