# Do FDA regulations apply to imported goods?
**URL:** https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821
**Category:** Factual Questions
**Created:** [June 19, 2016, 8:55pm UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821 "2016-06-19T20:55:49Z")
**Posts on this page:** 11
**Page:** 1
### Author:  [@boffking](https://boards.straightdope.com/u/boffking)
#### Post date: [June 19, 2016, 8:55pm UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821/1 "2016-06-19T20:55:49Z")
Some people I know have been talking about food and meds made in China, and how these are dangerous because China doesn’t have the regulations we do. Don’t our regulations still apply if it is going to be sold here in the USA? I can’t imagine inspectors give dangerous goods a free pass just because they come from somewhere else.
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### Author:  [@D\_Anconia](https://boards.straightdope.com/u/D_Anconia)
#### Post date: [June 19, 2016, 9:04pm UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821/2 "2016-06-19T21:04:30Z")
> [@boffking](#):
>
> Some people I know have been talking about food and meds made in China, and how these are dangerous because China doesn’t have the regulations we do. Don’t our regulations still apply if it is going to be sold here in the USA? I can’t imagine inspectors give dangerous goods a free pass just because they come from somewhere else.
Yes, FDA regulations apply to imported food and drugs.
[http://www.fda.gov/ForIndustry/ImportProgram/default.htm](http://www.fda.gov/ForIndustry/ImportProgram/default.htm)
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### Author:  [@rbroome](https://boards.straightdope.com/u/rbroome)
#### Post date: [June 19, 2016, 10:17pm UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821/3 "2016-06-19T22:17:12Z")
The real problem isn’t that the regulations don’t apply, they do, but that there are nowhere near enough inspectors to look at all the goods coming in to the US. Something like 1% of the goods (depending on how you wish to measure them) of the goods entering the US is inspected. So a major problem with Chinese goods is simply that they may not be what is claimed.
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### Author:  [@Exapno\_Mapcase](https://boards.straightdope.com/u/Exapno_Mapcase)
#### Post date: [June 19, 2016, 10:23pm UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821/4 "2016-06-19T22:23:47Z")
> [@D\_Anconia](#):
>
> Yes, FDA regulations apply to imported food and drugs.
>
> [Import Program – Food and Drug Administration (FDA) | FDA](http://www.fda.gov/ForIndustry/ImportProgram/default.htm)
Note that the link says:
> [@](#):
>
> All products regulated by the Food and Drug Administration must meet the same requirements
Most supplements, dietary aids, nostrums, herbs, and all the other stuff that fill stores are not regulated by the FDA. Congress has specifically precluded the FDA from regulating the supplement industry. They are not “drugs” or “medications.” They are entirely legal as long as they do not make specific health claims.
> [@](#):
>
> FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.
>
> The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market.
>
> If the dietary supplement contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing. However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness.
>
> Manufacturers are required to produce dietary supplements in a quality manner and ensure that they do not contain contaminants or impurities, and are accurately labeled according to current Good Manufacturing Practice (cGMP) and labeling regulations.
>
> If a serious problem associated with a dietary supplement occurs, manufacturers must report it to FDA as an adverse event. FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.
So something that is called, say, ginkgo baloba could contain some, all, or none of actual ginkgo biloba. It could have any strength of ginkgo biloba, including lethal dosages. It could have anything added to the ginkgo biloba, including cheap adulterants that may be poisonous. That’s illegal, strictly speaking, but the FDA can’t possibly look into every product sold over the Internet. They normally find out about problems after their bad effects are reported.
This is true for products made in the U.S. as well as those imported. If you want to take ginkgo biloba your best bet is to get it from some company you trust for quality, purity, and reliability. That’s much harder to do from companies in other countries, especially those whose language you can’t read.
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### Author:  [@D\_Anconia](https://boards.straightdope.com/u/D_Anconia)
#### Post date: [June 19, 2016, 10:26pm UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821/5 "2016-06-19T22:26:45Z")
So what? The OP specifically asked about food and meds, not supplements.
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### Author:  [@OldOlds](https://boards.straightdope.com/u/OldOlds)
#### Post date: [June 19, 2016, 11:33pm UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821/6 "2016-06-19T23:33:03Z")
I won’t speak to food, as that’s not my industry. But I have been dealing with the FDA on pharmaceuticals for over 20 years, and one of my current roles is to set up production overseas, sometimes for local supply and sometimes to bring back to the US.
The FDA regulations apply to everything sold legally in the US (under their purview, which as mentioned above isn’t everything but it is all drugs). Many of the pharmaceuticals you get will have been made in foreign factories which will have been required to meet the same requirements as a US factory. Part of bringing any new product to market, or of changing factories, or of opening a new factory is a Pre-Approval Inspection (PAI) by the FDA. So a Chinese firm, or a US firm using Chinese facilities, will have been inspected. Furthermore, the FDA does look at the supporting facilities (testing labs, critical suppliers, etc) and inspects them as well.
US customs is on the lookout for drugs coming in and actually coordinates with FDA to ensure that a shipment is approved by them. I frequently have headaches around this when customs thinks something is FDA regulated but isn’t, and I have to clear that up before it can come in. So they do a pretty good job watching.
So, at least in theory, if it is here legally it’s been through the appropriate checks.
Editorializing:
However, the FDA is really operating under the assumption that it’s companies are trying to do the right thing, and it isn’t that hard to fake it if you’re determined and operating in an environment where there is an acceptance of cheating. Further, it doesn’t help if you’re someplace where the FDA can’t come down on you. The worst the FDA can really do to a Chinese company is prevent their imports. Finally, I mentioned above that the FDA goes out a layer or two looking at support operations, but as you can imagine it is much more difficult for them to do their job in China or India than it is in Ohio. As such, most of us suspect that the rigor just isn’t there like it is here.
I work with groups at many of the major pharma companies, and the general consensus on India and China is that they really aren’t quite ready to supply finished pharmaceuticals (what we call drug product) to the US, and the liability scares most of us. So when we work there we often like to produce locally for local use, rather than export. However, we are starting to use more and more Active Pharmaceutical Ingredients (APIs) from those places, but it’s mush easier for us to verify the quality of these as compared to finished product.
Over time, I am sure we will see the Chinese and Indian operations come up to speed. In the meantime, the major Indian pharmaceutical companies seem to be on a buying spree (smart move, IMO). After a string of negative inspections back in India, they are buying US production facilities that are already operating in good standing and moving their products into them.
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### Author:  [@Exapno\_Mapcase](https://boards.straightdope.com/u/Exapno_Mapcase)
#### Post date: [June 20, 2016, 1:55am UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821/7 "2016-06-20T01:55:29Z")
> [@D\_Anconia](#):
>
> So what? The OP specifically asked about food and meds, not supplements.
A. The FDA doesn’t regulate foods in the first place.
B. I don’t know what the OP meant by meds. There’s about a million things people call meds but legally are supplements.
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### Author:  [@spamforbrains](https://boards.straightdope.com/u/spamforbrains)
#### Post date: [June 20, 2016, 2:06am UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821/8 "2016-06-20T02:06:40Z")
> [@](#):
>
> The FDA doesn’t regulate foods in the first place.
yes it does. What do you think the “F” stands for?
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### Author:  [@D\_Anconia](https://boards.straightdope.com/u/D_Anconia)
#### Post date: [June 20, 2016, 2:55am UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821/9 "2016-06-20T02:55:15Z")
> [@Exapno\_Mapcase](#):
>
> A. The FDA doesn’t regulate foods in the first place.
Food safety, then. What’s your point?
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### Author:  [@OldOlds](https://boards.straightdope.com/u/OldOlds)
#### Post date: [June 20, 2016, 3:08am UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821/10 "2016-06-20T03:08:04Z")
> [@Exapno\_Mapcase](#):
>
> A. The FDA doesn’t regulate foods in the first place.
> B. I don’t know what the OP meant by meds. There’s about a million things people call meds but legally are supplements.
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/default.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/default.htm)
Note that there are a significant number of warning letters issued to food companies. Without looking closely I see a Bakery and a Whole Foods.
A Warning Letter is the last stop before the FDA makes you very miserable.
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### Author:  [@Exapno\_Mapcase](https://boards.straightdope.com/u/Exapno_Mapcase)
#### Post date: [June 20, 2016, 3:20am UTC](https://boards.straightdope.com/t/do-fda-regulations-apply-to-imported-goods/757821/11 "2016-06-20T03:20:00Z")
> [@D\_Anconia](#):
>
> Food safety, then. What’s your point?
That “meds” is an ambiguous term. If the OP stops back he can define what he meant.