Ensuring high-quality dietary supplements with 'quality-by-design' - QbD

The U.S. Food and Drug Administration (FDA) regulates dietary supplements as a category of foods, rather than drugs.

Ensuring high-quality dietary supplements with 'quality-by-design':

"They concluded that a QbD approach — ensuring the quality of a product from its very inception — is the best strategy. One key step in applying QbD to dietary supplements, for instance, would involve verifying the identities of the raw materials — the plants — used to make supplements. “It is clear that only a systematic designed approach can provide the required solution for complete botanical characterization, authentication and safety evaluation,” they say."

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Drugs May Last Past The Expiration Date

What Expiration? Your Drugs May Last A Long Time // Pharmalot:

"Next time you decide to toss that prescription medicine because it appears to have expired, you may want to think twice. Why? A new analysis indicates that some prescription drugs retain their potency long after the expiration date, and the finding also suggests that the healthcare system could save untold oodles of money if expiration dates were sufficiently extended.

To wit, a team of researchers analyzed 14 different medications and found that 12, or 86 percent, tested at concentrations that were at least 90 percent of the amount on the labeling. Three actually had concentrations that exceeded the labeling; just two medications had less than 90 percent of the labeled concentration, according to a research letter published in the Archives of Internal Medicine"

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For more information (link to the original Arch Intern Med article):
Stability of Active Ingredients in Long-Expired Prescription Medications

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Top counterfeit drug events in 2012

The article provides links to the related drug event stories.

Top counterfeit drug events in 2012 - FiercePharma:

"This report points to some of the most significant events in the effort to address counterfeiting this year. Maybe you know of others not mentioned. It would be great if the report could start a public discussion of which steps need to be emphasized next. There is little question that more needs to be done, and it is best if it is done with some forethought. -- Eric Palmer"

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FDA Food Inspections Fail To Catch Vast Majority Of Pathogens

FDA Food Inspections Fail To Catch Vast Majority Of Pathogens, 'Bloomberg Markets' Finds:

"The U.S. federal government has been fighting foodborne illness for a century, ever since Upton Sinclair terrified the country with The Jungle, his expose of the Chicago meatpacking industry. Many think these measures have been successful. House Republicans, for example, recently voted to cut the FDA's budget for food safety, using the argument that our food system is "99 percent safe."

Widely-touted statistics about the prevalence of food poisoning cast some serious aspersions on that idea. In 2011, 48.7 million Americans contracted a foodborne illness. Of those, 127,839 were hospitalized and 3,037 died."

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FDA seeks to reargue cigarette-warning label rules

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Updated July 6, 2021

The original link broke.

You can read more about the history of this topic here:

Federal appeals court strikes down FDA tobacco warning label law - CNN

---  the original post follows below  ---

My gut sense is that the proposed cigarette-warning labels would be effective. When I look at them, they make me feel uneasy.

FDA seeks to reargue cigarette-warning label rules:

"The agency in a filing today in the U.S Court of Appeals in Washington said the court's 2-1 ruling finding the regulations violated the free speech rights of tobacco companies under the First Amendment of the U.S. Constitution was wrong and conflicts with a ruling by a federal appeals court in Cincinnati.
The majority on the three-judge panel said in August that the government failed to present any data showing the warnings would cut smoking rates.

"The First Amendment does not require statistical proof of the extent to which the decline in smoking rates resulted 'directly' from the new health warnings," the FDA said in today's filing."

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