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HUB Heads UP Announcement
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Being Well Informed Helps Us and Our Clients
to Be Prepared & Choose Our Responses Wisely
Please read this entire email.
Share with colleagues and clients that you believe
will benefit from a Heads Up about recent FDA actions.
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| The FDA continues its attention to homeopathic products |
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Last month the HUB newsletter included news about the FDA’s warning letters for homeopathic eye drops. None of these warnings were initiated by consumer complaints. The FDA continues its efforts to address homeopathic products used in other ways than oral / topical.
In some cases, the FDA was notifying companies that there were quality problems with their manufacturing. In other cases, the FDA was warning companies about the labeling of their homeopathic eye drops for specific conditions such as pinkeye, cataracts and glaucoma.
The companies were given 15 days to respond to the FDA, outlining how they intended to address the FDA’s warnings. Similisan has stopped sales of their eyedrops in the US. Read more… Walgreens and CVS removed the identified eyedrop products from shelves.
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The FDA is Checking
Homeopathic Packages
Entering the US |
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The package pictured here was shipped from Helios pharmacy in the UK (Sept 25, 2023) to a homeopath in the US. While in US Customs, the package was opened, examined, marked with a notice by the FDA Office of Regulatory Affairs, and sent on to the recipient, still containing the ordered remedies (October 30, 2023).
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NOTE: This only applies to international pharmacy shipments
This checking of packages coming through US Customs by the FDA is not NEW – there have been reports of remedy packages opened or held or refused/returned over the past several years.
We do not know the criteria being used to evaluate contents of any package opened and examined. We do not know the extent of the current vetting of packages entering the US from foreign homeopathic pharmacies.
Let’s take this opportunity to team up together.
Inspired by Hahnemann, let’s ‘take the case’ of this situation
by gathering data about homeopathic packages
coming through US Customs.
Once we know more about this, we will be better prepared,
as a community, to formulate wise actions moving forward.
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| Here are actions to take now: |
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Be aware that you or your colleagues, clients, friends or family who order from international homeopathic pharmacies may receive a package with a large red sticker from the FDA.
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Share factual information with your clients, friends or family, using concise statements such as: “The FDA is inspecting some packages coming through customs. We are learning more about this now. You may see a sticker on products you order.”
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Confirm with clients, friends or family that these large red stickers do not mean there is anything wrong with the remedies they received. Reduce their stress and fear with factual statements – being aware of the possibility in advance is helpful.
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Continue to order from international pharmacies as you have been, marking your calendar with the order date and expected arrival date – monitor the status to notice if a package appears to be delayed.
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Discuss with colleagues and friends in person, by phone or through email, rather than social media. Share this email with colleagues and others where appropriate.
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Stick with the facts we know: some packages of remedies are being examined by the FDA in Customs, then sent on to the recipient.
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Build package inspection data for our community by entering info about each package you receive from an international pharmacy in a simple survey form. Homeopaths can use this form for their clients’ remedy shipments as well as for their own packages.
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| Here are actions to avoid: |
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- Don’t conjecture or make assumptions about the FDA’s actions – we are gathering data so that we can make reasonable conclusions when we can quantify the situation.
- Don’t search the internet about FDA warnings and then click through, increasing hit rates on those webpages
- Don’t share or discuss on social media about these international package inspections. The homeopathic profession does not benefit from social media messaging on this topic.
- Don’t contact the FDA with complaints about their package examination actions.
- Don’t stop ordering from international pharmacies as you have been in the past.
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Please share status for your international remedy order packages coming through US Customs.
The resulting data will be collated and reported.
Anyone can use this package data collection survey – you do not need to be registered or subscribed to the HUB.
Here is the direct link to the survey:
(You can Cut / Paste / Bookmark / Share)
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Copyright TrinityHealthHub.com 2023
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