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

The link in the original post broke.

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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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FDA issues draft guidance on nanotechnology

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Updated June 25, 2023:

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GUIDANCE DOCUMENT - Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry - APRIL 2022 - FDA.gov

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Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.

Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers – particles so small that they can not be seen with a regular microscope. The technology has a broad range of potential applications, such as the packaging of food or altering the look and feel of cosmetics.

Press Announcements - FDA issues draft guidance on nanotechnology:


The two draft guidance documents are: “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.”

The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:

• affect the identity of the food substance;
• affect the safety of the use of the food substance;
• affect the regulatory status of the use of the food substance; or
• warrant a regulatory submission to FDA.

The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:

• The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled.
• To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.

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As Mobile Applications Cross Over Into FDA Regulatory Territory, New Frictions Emerge

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Updated April 9, 2024

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Device Software Functions Including Mobile Medical Applications - FDA.gov

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We want mobile apps, and it's going to be a very tough regulatory balancing act . . .

As Mobile Applications Cross Over Into FDA Regulatory Territory, New Frictions Emerge - RAPS - News - Article View:

"The emerging clash follows FDA’s promulgation of draft guidance in July 2011, when it proposed some basic regulatory principles for mobile medical application developers. Those principles include which apps would—and which apps would not—be regulated under FDA’s authority, FDA’s regulatory approach toward those applications, general categories for mobile medical applications and corresponding levels of anticipated FDA regulation, and regulatory requirements for developers and manufacturers of applications.

“That seemed reasonable enough to the traditional medical-device industry, which is well-versed in the ways of the FDA,” explained Politico. “But the requirements — data on effectiveness, possibly clinical trials — have gobsmacked some software developers who are used to working in the fast-paced, relatively unregulated wilds of the Internet.”"

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Mesothelioma Blog: Golfer Fred Couples designates Presidents Cup funds to mesothelioma research

Mesothelioma Blog: Golfer Fred Couples designates Presidents Cup funds to mesothelioma research | myMeso:

"Professional golfer Fred Couples designated $25,000 from the 2011 Presidents Cup tournament to go to the Mesothelioma Applied Research Foundation. The Presidents Cup tournament raised a record-setting $4.5 million in proceeds to be distributed to charitable organizations around the world. Beneficiaries are chosen by the 30 players, captains and captains’ assistants. Couples chose the Meso Foundation with his girlfriend and caddy, Midge Elo Trammell, whose father, George Sheldon Elo, passed away in 2009 after a battle with pleural mesothelioma."

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FDA Publications in Foreign Languages

FDA Publications in Foreign Languages:

"The FDA’s Office of International Programs (OIP) has redesigned its webpage for FDA Publications in Foreign Languages. It is our hope that the featured content is presented in a more user-friendly format. OIP has categorized the content per product type. Currently, we have featured five product types: cosmetics, drugs, food, medical devices, and veterinary. Each product type will list document titles in a foreign language. Also, upon accessing product page, you will be able to access an inventory of all the translated documents that are featured on OIP’s webpage. You will be able to sort by product type, language, etc. In addition, there are additional informative topics that are presented below. There will be additional translations featured on this page, so please come back to see what else OIP has to offer you."

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Turning Stem Cells into a Powerful Weapon Against AIDS

Updated February 17, 2022

Some current news:

Maryland HIV researcher on latest research: It's not a cure - WBALTV - "Scientists used a cutting-edge stem cell transplant method to treat a woman's HIV, but a lead researcher in Maryland said it's too soon to celebrate. | A U.S. woman is the third known person who is in HIV remission after receiving stem cells from umbilical cord blood, an American research team announced Wednesday."

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Turning Stem Cells into a Powerful Weapon Against AIDS | NBC Los Angeles:

"They figured out how to engineer stem cells taken from adult blood, and turn them into immune cells that attack and kill the HIV virus.

The history making breakthrough even surprised them.

"We knew that the results were coming down the pike," says UCLA researcher, Dr. Jerome Zack. "When they finally came out we looked and went, that's pretty good."

So far the technique has been successful in attacking HIV in hundreds of lab mice.

"We haven't fully developed the technology to clear them of HIV, but they are significantly suppressed in the amount of virus that’s replicating," says researcher Dr. Scott Kitchen.

Researchers say human clinical trials are the next step."

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FDA Compliance & Enforcement - Inspection of Cosmetics: An Overview

FDA Compliance and Enforcement; Inspection of Cosmetics: An Overview:

"Section 704 of the Federal Food, Drug, and Cosmetic Act (FD and C Act) authorizes FDA to conduct inspections of cosmetic firms at reasonable times, in a reasonable manner, and without prior notice in order to assure compliance with the applicable laws and regulations, to determine whether cosmetics are safe and properly labeled, and to identify possible health risks and other violations of the law.

A number of factors affect how FDA determines that an inspection of a cosmetic establishment may be warranted. These factors may include--but are not limited to--the type of products, the significance of consumer or trade complaints received, the company's compliance history, FDA surveillance and compliance initiatives, and agency resources.

Some things to know about inspections: . . . "

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Follow the link above to read the full FDA article.

Although there are no good manufacturing practice (GMP) regulations for cosmetics, the FDA offers a Good Manufacturing Practice Guidelines (Inspection Checklist). Failure to adhere to GMP may result in an adulterated or misbranded product.

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Online Pharmacy Scam: Consumers Blackmailed | Video

If you order medications over the internet, be on the lookout for this blackmailing scam . . .

Online Pharmacy Scam: Consumers Blackmailed | Video - ABC News:   ( 'via Blog this' )

Tainted Sexual Enhancement Products - FDA on Medication Health Fraud

Medication Health Fraud; Tainted Sexual Enhancement Products:

"FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement."

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FDA's Stance On Online Pharmacies May Go Too Far, Study Says : Shots - Health Blog : NPR

FDA's Stance On Online Pharmacies May Go Too Far, Study Says : Shots - Health Blog : NPR:

"The Food and Drug Administration has warned people about the many dangers of buying medications from foreign pharmacies over the Internet. While some sites might offer high-quality medicines, there are plenty that sell bogus and potentially dangerous products.

But a recent economic analysis suggests that while there's good reason for the safety warnings, the FDA's stance on the matter might go too far. Many Americans don't fill their prescriptions because they can't afford to, the study says, and some legitimate foreign pharmacies may offer medicines at prices lower than those of verified U.S. suppliers."

. . . "In light of this," the researchers asked, "we wonder whether a blanket warning against foreign websites has limited price competition between U.S. and foreign websites, and whether a more open and educational policy could make better use of the existing verification services for consumer savings in authentic drugs."

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Read about the FDA's stance on Buying Medicines Over The Internet

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FDA Gives Safety Tips For Dyeing Eater Eggs

Refrigerate eggs promptly.
Keep clean.
Cook eggs thoroughly.
Separate (i.e., Never let raw eggs come into contact with any food that will be eaten raw)

FDA Gives Safety Tips For Dyeing Eater Eggs « CBS Detroit:

"Colored eggs are emblems of Easter. But eggs, when not handled with special care, can cause food poisoning. The FDA has provided a few quick tips about dealing with eggs to help prevent foodborne illness.

Salmonella, an organism that causes nausea, vomiting, diarrhea, cramps, and fever, can be found on both the outside and inside of eggs that look perfectly normal."

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FDA - Drug Integrity and Supply Chain Security - Another counterfeit cancer medicine found in U.S. - Illegal practice puts patients at risk

Updated May 4, 2023

The original link broke.

You can still read about the issue here:

GENENTECH STATEMENT ON COUNTERFEIT DRUG LABELED AS ALTUZAN (BEVACIZUMAB) IN THE UNITED STATES

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FDA - Drug Integrity and Supply Chain Security; Another counterfeit cancer medicine found in U.S. - Illegal practice puts patients at risk:

"Patients receiving cancer drugs or other drugs not approved by the FDA for the U.S. market may not be receiving needed therapy. Patients are encouraged to discuss any concerns they may have about the source of their medications with their healthcare professional.

FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab), an injectable cancer medication, found in the U.S. contains no active ingredient.  Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey).  On February 14, FDA issued an alert about another cancer drug in U.S. distribution that was purchased from a foreign source and found to be counterfeit."

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FDA'S Response To Cargo Thefts

The FDA wants to make sure that drugmakers do more than bolster internal operations. In a new standard operating procedure, the agency wants the pharmaceutical industry to know that there are various obligations when a theft occurs and this includes alerting regulators and the public.

FDA STAFF MANUAL GUIDES, VOLUME IV - AGENCY PROGRAM DIRECTIVESGENERAL OR MULTIDISCIPLINEFDA'S RESPONSE TO CARGO THEFTS - Effective Date: 03/23/2012

The purpose of this Standard Operating Procedure (SOP) is to provide a general procedure for determining FDA’s regulatory response when a cargo theft involving an FDA-regulated product has occurred. When followed in conjunction with the established procedures for product removal from the market, public notice, and handling medical product shortages, if applicable, the procedures described in this document will ensure that FDA’s regulatory response to cargo thefts is consistent and effective.

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