FDA Sends Out 10 Warning Letters to Dietary Supplement Manufacturers

FDA Sends Out 10 Warning Letters to Dietary Supplement Manufacturers | Eye on FDA:

"10 Count ‘em 10.

That is how many Warning Letters the agency sent out last Friday to manufacturers and distributors of dietary supplements.  The specific focus of the letters was products that were being marketed containing dimethylamylamine, also known as DMAA, sold as a “natural stimulant”.

The list contains 10 different manufacturers covering 15 separate products.

The specific violation cited in the letters was that current law states that when supplements contain dietary ingredients not marketed before October 15, 1994, manufacturers must submit the new ingredient for use as a New Dietary Ingredient, notifying FDA of evidence that supports a conclusion that use is safe.  The agency said in the letters that this requirement had not been met."

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Drug Disposal - National Take-Back Initiative

Drug Disposal - National Take-Back Initiative:

"April 28, 2012 - 10:00 AM - 2:00 PM

The Drug Enforcement Administration (DEA) has scheduled another National Prescription Drug Take-Back Day which will take place on Saturday, April 28, 2012, from 10:00 a.m. to 2:00 p.m.  This is a great opportunity for those who missed the previous events, or who have subsequently accumulated unwanted, unused prescription drugs, to safely dispose of those medications.

Americans that participated in the DEA’s third National Prescription Drug Take-Back Day on October 29, 2011, turned in more than 377,086 pounds (188.5 tons) of unwanted or expired medications for safe and proper disposal at the 5,327 take-back sites that were available in all 50 states and U.S. territories. When the results of the three prior Take-Back Days are combined, the DEA, and its state, local, and tribal law-enforcement and community partners have removed 995,185 pounds (498.5 tons) of medication from circulation in the past 13 months."

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Press Announcements - FDA approves Stendra for erectile dysfunction

Updated December 30, 2019

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FDA Approves New Erectile Dysfunction Drug Stendra - WebMD

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Do we really need another one?!  And what about the name!?

Press Announcements - FDA approves Stendra for erectile dysfunction:

"The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.

Erectile dysfunction is when a man has trouble getting or keeping an erection. An estimated 30 million men in the United States are affected by erectile dysfunction.

Stendra is a pill that patients take on an as-needed basis 30 minutes before sexual activity. Doctors should prescribe the lowest dose of Stendra that provides benefit."

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FDA ‘Aghast’ at Lack of cGMP, AER Compliance by Supplement Manufacturers

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Updated September 26, 2022

Sadly, the original link broke.

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FDA ‘Aghast’ at Lack of cGMP, AER Compliance by Supplement Manufacturers - RAPS - News - Article View:

"The US Food and Drug Administration’s (FDA) top dietary supplement regulator said at an industry conference meeting he is “aghast at the degree of non-compliance” when it comes to current good manufacturing practices (cGMPs) and adverse event reporting (AER) in the industry, reports Nutra Ingredients USA.

Speaking 25 April to a meeting convened by the Natural Products Association, Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs, said the industry has been exhibiting a level of non-compliance he says is troubling."

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FDA Global Initiative

Updated June 30, 2024

The original links broke.

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Office of Global Policy and Strategy - FDA.gov

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FDA’s success in protecting the U.S. public depends increasingly on its ability to reach beyond U.S. borders and engage with its government regulatory counterparts in other nations, as well as industry and regional and international organizations, to help ensure the quality and safety of products before they reach the United States.

Through effective global engagement, FDA is working with its many international partners to weave a global safety net that benefits public health in the United States and around the world.

• Report: Global Engagement (PDF - 5 MB)

FDA Global Initiative: 


"Global production of FDA-regulated products has quadrupled over the last decade and continues to grow.  Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities.


Almost 40 percent of the fruits and nuts and 85 percent of the seafood consumed in America comes from abroad.  Similarly, more than 80 percent of the active pharmaceutical ingredients used to make medicines are imported. The growth in imports has been rapid and promises to accelerate.


Globalization has fundamentally altered the economic and security landscape and demands a major change in the way FDA fulfills its mission.  Over the next decade, FDA will transform from a predominantly domestically-focused agency operating in a globalized economy to a modern public health regulatory agency fully prepared for a complex globalized regulatory environment."

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