FDA - Seizes & Shuts Down 1,677 Illegal Rx Websites

Press Announcements > FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies:

"The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide."

"The FDA’s Office of Criminal Investigations Cybercrime Investigations Unit banner is now displayed on seized websites to help consumers identify them as illegal. Here are some examples:

• http://www.canadianhealthandcaremall.com/
  
• http://www.walgreens-store.com
  
• http://www.c-v-s-pharmacy.com  "
  

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Pharma & Pers Care Products - In The Top 10 Most Counterfeited

The 10 Most Counterfeited Products - Business Insider:

An estimated $83 million worth of pharmaceuticals and personal care products were seized in 2012, down from nearly $142 million just a year earlier.

China was responsible for most of the seized counterfeit drugs and personal care items, with an estimated $46.9 million worth of products.

You might also be interested in:
Customs and Border Protection - Seizure Statistics

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FDA Seizes Illegal Dietary Supplements in FL

FDA Seizes Illegal Dietary Supplements in FL | Designated Representative and Exemptee:

"WASHINGTON: FDA seizes illegal dietary supplements in Florida - Business Breaking News - MiamiHerald.com:

"Several of the supplements from Globe All Wellness LLC contain the active ingredient in Meridia, a weight loss drug that was withdrawn from the market in 2010. The drug was pulled after studies showed it could increase the risk of heart attack and stroke.

Among other problems, the Hollywood, Florida-based company made unsubstantiated claims about the benefits of its products and did not comply with manufacturing standards."

For additional details:
FDA Warning Letters - Globe All Wellness, LLC 2/6/12

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Related articles

• Titan Medical Enterprises Shut Down for GMP Violations (drughealth.blogspot.com)

US counterfeit drug seizures up 200 per cent in 2011

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Updated May 11, 2022

The original link broke.

You can still read about the same topic here:

US fake drug seizures up 200% - outsourcing-pharma.com

---  the original post follows below  ---

SecuringPharma - US counterfeit drug seizures up 200 per cent in 2011:

"China remained the primary source of counterfeit goods across all categories, representing 62 per cent of all seizures by value, with the value of pharmaceutical seizures from China increasing by more than $4.3m and the value of perfume seizures up $7m on the prior year.

Meanwhile, India and Pakistan both featured in the top 10 source countries in 2011, mainly due to seizures of counterfeit pharmaceuticals. Pharmaceutical seizures accounted for 86 per cent of the value of seizures from India and 85 per cent from Pakistan, said the CBP.

The top 10 source countries - in descending order - were: China; Hong Kong; India; Pakistan; Taiwan; Switzerland; Malaysia; South Korea; UK; and Mexico."

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FDA Crackdown on Viagra-Like Supplements

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Updated November 12, 2020

Links broke in the original post.

You might also be interested in:  Tainted Sexual Enhancement Products - FDA.gov

- - -  original post follows below  - - -

FDA Crackdown on Viagra-Like Supplements - Video - Bloomberg:

"The discovery came during a Food and Drug Administration inspection that’s part of an expanding crackdown by the agency on the $28 billion supplement industry."

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My gut sense tells me that this is just the tip of the iceberg, a problem of enforcement that the FDA will be hard pressed to wrap their arms around.

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FDA Seizes Millions Worth of Unapproved New Drugs

• FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training
  

Updated January 31, 2021

Links in the original post broke.

People also ask about:

Guidance for FDA Staff and Industry Marketed Unapproved Drugs – Compliance Policy Guide

Sec. 440.100  Marketed New Drugs Without Approved NDAs or ANDAs 

- - -  original post follows below  - - -

This makes me think twice. The FDA and US Marshals caught this one though, "Federal Agents Seize more than $24 Million in Unapproved New Drugs Products made after the FDA required an end to production." As a consumer, I wonder how many manufacturers simply ignore the regulations and get away with it. As a GMP trainer, this situation makes another good example to add to your gmp training war stories. Additional FDA-related resources related to this post:

1. Guidance for FDA Staff and IndustryMarketed Unapproved Drugs —Compliance Policy Guide
2. FDA cracking down on unapproved prescription drugs.(Practice Trends)(Food and Drug Administration): An article from: Internal Medicine News
3. Serious Problems With Generic Drug Makers In U.S. Continue To Be Discovered

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