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    1. Lamisskay's Avatar
      Lamisskay is offline

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      #1

      Restrictions on importing Chinese herbs

      Ive got a fairly successful naturalpathic storefront using mostly domestic product, but have recently gotten requests for Chinese imported remedies. Anyone out there have information on the kinds of restrictions the US puts on herbal remedies imported from China?
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      That really depends on what you intend to do with the herbs. Heres what you can claim them as -- cosmetics, curative/tonic, paints, dyes, insecticides, or detergents. Lycium chinense, used in trail mixes is a food, but could conceivably be classified as a drug, as it is claimed to have a positive effect on the heart and lungs.

      A drug is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and articles (other than foods and dietary supplements) intended to affect the structure or any function of the body.

      https://www.wholesaleforum.com/discu...etic-act-4242/

      Most herbs used in traditional Chinese medicine (TCM) will be classified as drugs by the FDA, and will likely need certification to enter the country. By and large, in order to import an herbal remedy into the country, there must exist evidence of--

      Well documented traditional usage.

      Not terribly difficult in Chinese herbs. The library of classic herbal medicine texts is still a foundation for the science behind medicine in China.

      Single-plant medicines. That is, a plant is a complete remedy in and of itself. Think of aloe on a burn, tobacco on an insect sting, Valerian root for sleeplessness.

      Medicinal plants free from pesticides, heavy metals, et al.

      Environmental controls are lax in China when compared to what we have in the States. Insecticides and other sprays arent often used due to their expense, but lead and other metals are still often present in the soil and water. The FDA requires that anything intended for consumption by humans meets the same standards for purity and cleanliness as consumables produced domestically.

      Standardization based on chemical activity profiles

      basically; agreement on chemical definitions is focused on what the chemical does.

      So long as the ingredients havent been formally refused import, you likely wont run into any problems. As a way to insure this (and to avoid any nasty entanglements in anti-bioterrorism legislation), youll need to provide the FDA with Prior Notice. Head over to the FDA site, for a quick start guide.

      You will basically need--

      ● Description of the items to be imported-- one entry per item.
      ● The mode of entry for the ingredients
      ○ i.e, straight to the marketplace, dry storage, cold storage, transport by baggage, entry into a Foreign Trade Zone, etc.
      ● Port of arrival
      ● Name of the exporter and importer (you)
      ● Domestic carrier (if any)
      ● FDA product code, if available.
      ● Quantity and type of packaging
      ● Manufacturer, if any

      This, barring any controlled or refused items, will expedite your importing and should prevent most problems with the FDA and customs.

      Youll want to contact the FDA for specifics on any ingredients or preparations that have been refused import. Fundamentally, thats all you really need to be concerned about. You should be able to find an up-to-date list on the FDA website (Id link it here, but their surveillance alert tool has been down of late). Stay away from the obviously dangerous stuff (Double Dragon pills, etc.), and provide the FDA with Prior Notice, and you should be fine.

      Reasons Why Chinese Remedies may be Restricted

      A major concern still involved in medicinal herbs from China is the level of toxins in the ingredients themselves. Lead, arsenic, and mercury are particularly likely to show up. Cinnabar, zhūshā (朱砂), is a major component in medicinal preparations, and is an ore of mercury. Likewise, the mineral realgar is an ore form of arsenic. Cinnabar is toxic to consume, but realgar isnt intrinsically poisonous.

      The concentrations created by traditional preparations (like boiling the components down, and drying the resulting liquid into a paste or powder) can easily result in high enough levels of toxic metals that it becomes an issue. Realgar is often found with raw arsenic, and anything dug up out of the ground has the potential of having levels of lead mixed in with the target ore. Combine this with the relative low safety standards on lead exposure found in the rural regions of China where most of the ingredients are found by necessity, and its clear just why heavy metal toxicity-- lead and mercury in particular-- is such a concern with herbal preparations from China.

      Id keep away from items like Double Dragon Pills, which have concentrations of lead 30 times that of the allowed level of 10 parts-per-million (PPM). Likewise, any preparation using cinnabar is going to have potentially high levels of mercury. Pay attention to the ingredients in the remedies you import, and keep an eye on your customers safety.

      Much of the issue is with the ingredients themselves, since even those preparations whose constituent parts are produced in the States are questionable in safety at best. Levels in naturalpathic remedies are difficult to control, and until recently the FDA hasnt required facility testing in domestic remedy companies. New legislation is most likely going to change that, with tighter controls expected on herbal and traditional remedies kicked-off from such things as inconsistent levels of the highly toxic belladonna in infant teething tablets.
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      #3
      Ill definitely make sure I pay attention to the ingredients before I approach the FDA and potentially waste a lot of time. Thanks for letting me know all this!

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