2013 Food Code is Out - Time for Light Reading | Marler Blog

2013 Food Code is Out - Time for Light Reading | Marler Blog:

"This Summary provides a synopsis of the textual changes from the 2009 FDA Food Code and the Supplement to the 2009 Food Code Chapters and Annexes to the 2013 edition. The primary intent of this record is to capture the nature of the changes rather than to identify every word or editing change. This record should not be relied upon as an absolute comparison that identifies each and every change."

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Herbal Supplements Are Often Not What They Seem - NYTimes.com

Herbal Supplements Are Often Not What They Seem - NYTimes.com:

"DNA tests show that many pills labeled as healing herbs are little more than powdered rice and weeds."

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Dietary Supplement Warning Letter Immersion Center - Letters Categorized by Type

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Updated July 22, 2021

The original link broke.

Read more about the topic here:

Warning Letters Related to Food, Beverages, and Dietary Supplements - FDA.gov

---  the original post follows below  ---

If you're tracking FDA Warning Letters issued to dietary supplement companies, follow the link below:

NPI Warning Letter Immersion Center:

"This Warning Letter Immersion Center is a place to find the latest information on warning letters sent to dietary supplement and related companies. Included is a table of all the known warning letters to date, including a link to the full text of each letter on FDA website."

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FDA - 70% of Supplement Companies Violate Rules

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FDA official: 70% of supplement companies violate agency rules:

"About 70 percent of the nation's supplement companies have run afoul of the U.S. Food and Drug Administration's manufacturing regulations over the past five years, according to a top agency official.

Consumers are put at risk by poorly measured ingredients, uncleaned manufacturing equipment, pesticides in herbal products, supplements contaminated with illegal prescription medications -- even bacteria in pediatric vitamins, recall notices and agency inspection records have shown."

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Dietary Supplement Label Database (DSLD) - New from the NIH & NLM

Dietary Supplement Label Database (DSLD):

"The Dietary Supplement Label Database (DSLD) is a joint project of the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) and National Library of Medicine (NLM). The DSLD contains the full label contents from a sample of dietary supplement products marketed in the U.S."

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FDA Cites 70% of Dietary Supplement Firms on GMPs

FDA GMP Inspectors Cite 70% of Dietary Supplement Firms:

"During a three-year period, federal inspectors have cited seven out of 10 facilities that make dietary supplements for violating regulations intended to ensure products are safe and contain the ingredients that are listed on the labels.

A total 444 out of 626 inspections for cGMPs (current Good Manufacturing Practices) resulted in the issuance of a "Form 483," according to data Natural Products INSIDER obtained through a Freedom of Information Act (FOIA) request."

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Sex Supplements - Containing Viagra; Other Issues

Sex supplements often contain Viagra ingredients | Reuters:

"Herbal supplements aimed at improving men's sexual abilities often contain the active ingredients in erectile dysfunction pills such as Viagra, according to a new study.

Additionally, researchers found that some of these over-the-counter herbal remedies contained more of the ingredient than is allowed in prescription-only pharmaceuticals."

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Supplements Involved in Half of Drug Recalls

Supplements Involved in Half of Drug Recalls:

"Analysis of FDA data showed 51% of Class I recalls over a 9-year period involved adulterated dietary supplements instead of a pharmaceutical product, Ziv Harel, MD, of St. Michael's Hospital in Toronto, and colleagues reported in a Research Letter published online in JAMA Internal Medicine.

Most of those supplements were either sexual-enhancement, body-building, or weight-loss aids, they reported."

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Dietary Supplement Industry - Vulnerable to FDA Enforcement

Dietary Supplement Industry: Everyone Vulnerable to FDA Enforcement:

"Who is at risk in the dietary supplement industry from the enforcement arm of FDA?

The short answer, says veteran attorney Anthony Young, is everybody.

"We are no longer an unregulated industry in any way," declares Young, a partner with Kleinfeld, Kaplan and Becker, a firm concentrating on the regulation of products subject to FDA jurisdiction."

'via Blog this'

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FDA and Supplement Regulations

Updated 11/7/2015:

You might have been looking for these:

Death By Dietary Supplement (Forbes) - Lamar Odom, etc.

USP launches new GMP audit certification program

By Stephen DANIELLS, 03-Nov-2015
There’s a new player in the GMP audit sector, with the United States Pharmacopeial Convention (USP) expanding its verification services to include a new GMP audit program for dietary supplement and dietary ingredient manufacturers.

= = = original post below = = =

This Slate article is an interesting read about the proliferation of dietary supplements, and the interest in tighter regulatory oversight.

Herbal supplement dangers: FDA does not regulate supplements and they can be deadly. - Slate Magazine:

"Between 1994 and 2008, the number of dietary supplement products on the market increased from 4,000 to 75,000. In the first 10 months of 2008, the FDA received nearly 600 reports of serious adverse events (including hospitalization, disability, and death) from these products and 350 reports of moderate or mild adverse events. However, the FDA believes that these reports are drastically underreported and estimates that the annual number of all adverse events is 50,000."

'via Blog this'

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FDA Closes Down Another Dietary Supplement Company

Updated September 17, 2024

You might also be interested in:

Dietary Supplements - FDA

---  the original post follows below  ---

Another dietary supplement company, PUH, closed down by FDA:

"Pharmacist’s Ultimate Health of St. Paul, Minnesota agreed to a consent decree to cease their unlawful distribution of unapproved new drugs and adulterated dietary supplements. They have to stop distributing their products until all disease claims are removed from their websites and product labels and they comply with cGMP requirements for dietary supplements.

The company marketed products capsules, topical creams, and botanical extracts under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy. The product names include Allergy Relief Complex, Lycopene Standardized Extract, Co Q-10, Cold and Flu Defense, Cholesterol Homocysteine, Prostate Companion, Ginger Root Standardized Extract, and Progesterone Cream, among others."

'via Blog this'

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FDA’s Top Supplement Issues

FDA’s Top Supplement Issues:

"Daniel Fabricant, Ph.D., Director, Division of Dietary Supplement Programs, FDA, gave a quick talk this morning at SupplySide West, touching on FDA’s top regulatory concerns for supplements. He said the most important topic is good manufacturing practices (GMPs), but that’s not the only supplement issue that’s currently top of mind to FDA.

In short, Fabricant said these are the most pressing industry issues: . . ."

'via Blog this'

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Related articles

• FDA Warns Dietary Supplement Firms to Stop Promoting Unapproved Products as Drugs (drughealth.blogspot.com)

What is GMP for Dietary Supplements - Free Video

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Updated August 12, 2021

The original video is no longer available.

You can still learn about the same topic in this video:

Regulatory Approaches to Dietary Supplements and their Claims (video)

---  the original post follows below  ---

This is a nice free video introduction to the FDA GMP regulations for dietary supplements.

Video no longer available.

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Related articles

• QSR & GMP Public Seminar - Trainer Certification - Skillslus

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• FDA Sends Out 10 Warning Letters to Dietary Supplement Manufacturers

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Knock, Knock, FDA Calling

This is a nice article with a nutritional supplement twist to it.

Knock, Knock, FDA Calling - Slowtwitch.com:

"In the United States, the Food and Drug Administration (FDA) is responsible for protecting and promoting public health with ultimate oversight of food and drugs, and of particular interest for this article, the nutritional supplement industry. Their regulatory control covers two main areas: product safety and accurate product labeling. This article summarizes some of what goes on behind the scenes to keep consumer products safer."

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• Live Onsite GMP Training - Olympics for Pharma & Biotech Manufacturers (skillsplusinfo.blogspot.com)
• Gluten in Drug Products - FDA Request for Info (drughealth.blogspot.com)

FDA Supplement Guidance Not Strict Enough, MD Says

This is pretty controversial stuff, as the dietary supplement industry largely opposes the draft regulation

Medical News: FDA Supplement Guidance Not Strict Enough, MD Says - in Public Health and Policy, FDA General from MedPage Today:

"An FDA proposal to require dietary supplement manufacturers to submit data proving their product is safe doesn't go far enough, according to a physician writing in the New England Journal of Medicine.  

More than 100 million Americans spend more than $28 billion on vitamins, minerals, herbal ingredients, amino acids and other natural products in the form of dietary supplements each year, "assuming they are both safe and effective," wrote Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance. 

But they have no assurance that the products are safe because FDA regulation of supplements is too weak, Cohen wrote in a Perspective piece."

'via Blog this'

Read more about this:

FDA Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues

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Drugs Posing as Supplementals May Contain Dangerous Ingredients - NYTimes.com

Drugs Posing as Supplementals May Contain Dangerous Ingredients - NYTimes.com ('via Blog this')

A good read on the shaky tension between legitimate, tainted, and dangerous supplements. The supplement industry blames the FDA for failing to institute mandatory recalls and seize tainted goods.

In a nutshell:

Daniel Fabricant of the FDA says, "the growing availability of tainted products represents a serious public health problem, one that could taint the dietary supplement industry as a whole."

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FDA Dietary Supplement Guidance for Small Businesses

Image via Wikipedia

The FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements set forth in the DS CGMP rule (21 CFR part 111). The DS CGMP rule is binding and has the full force and effect of law:

FDA: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide

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FDA Targets Tainted Dietary Supplements

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Updated February 2, 2021:

You might recall, among the warnings and alerts recently issued, the FDA warned people to stop using Man Up Now, a product marketed for sexual enhancement, as it contains a variation of a drug ingredient found in Viagra that can lower blood pressure to a dangerous level.

The FDA intends to:

• Send a letter to the dietary supplement industry, stressing its legal obligation to prevent tainted products from reaching the market, and emphasizing the possibility of criminal investigations against those who endanger public health by their involvement in tainted products.
• Implement a new, rapid notification system for the public on the FDA web site to alert the public quickly to tainted products marketed as dietary supplements.
• Put in place a mechanism for industry to alert the FDA about the tainted products and the firms involved.

The FDA letter:  The FDA on Tainted Products Marketed as Dietary Supplements

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Dietary Supplements - Legislation Introduced - S. 3414

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New dietary supplement legislation (S. 3414) has been introduced by Senators Harkin and Hatch, as reported by this Lexology article, Dietary supplements on the Hill - new legislation introduced.

In a nutshell:

1. It would allocate funds to the FDA to implement and enforce DSHEA.
2. It would require the FDA to make annual reports to Congress on its implementation and enforcement of DSHEA.
3. 180 days after the enactment of S. 3414, the FDA would be required to publish a guidance document on New Dietary Ingredients (“NDI”).

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Dr. Oz Show About Dietary Supplements

Here's something that might interest you if you follow manufacturing and regulatory issues, or possible health dangers, involving dietary supplements.

This post leads you to the very popular Dr. Oz Show episode aired April 27th 2010 about dietary supplements.  The episode has been uploaded to YouTube in 5 parts.

Therefore, here's the link to part 1 of 5, The Dr Oz Show April 27, 2010 part 1 of 5.   Enjoy!

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