Making Progress in Protecting Consumers from Unsafe Supplements | FDA Voice

Read Dr. Ostroff's (FDA) full comments: Making Progress in Protecting Consumers from Unsafe Supplements | FDA Voice:

"We want to expand our use of criminal investigation and enforcement tools to address serious safety-related violations and cases of intentional fraud; and further build strategic investigatory and enforcement collaborations with the Federal Trade Commission, Department of Justice, and state governments, including state health departments and attorneys general.

Ultimately our top priority is to protect the consumers who want to improve, not damage, their health and have a right to expect that dietary supplements will be safe for them and their families."

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Supplement-Maker Who Diluted Products With Other Powders Sentenced To 40 Months In Prison – Consumerist

Read the full article: Supplement-Maker Who Diluted Products With Other Powders Sentenced To 40 Months In Prison – Consumerist:

"When you buy a food product or a dietary supplement, you should be confident that the product’s ingredients are listed on the label, and that you’re getting what you paid for. Federal prosecutors say that one dietary supplement wholesaler in New Jersey spent four years selling products diluted with products like maltodextrin or rice flour, increasing profits but defrauding customers. The company’s owner now must forfeit $1 million in profits and has been sentenced to 40 months in prison and one year of supervised release."

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Questionable Remedies for Eye Disease - NYTimes.com

RE: slowing the progression of macular degeneration and reducing the risk of vision loss

Read the full article: Questionable Remedies for Eye Disease - NYTimes.com:

"Some contained the right ingredients but not the right doses. Some added other stuff (selenium, B vitamins, grapeseed extract) that hasn’t been shown to slow macular degeneration and might actually reduce the effectiveness of the ingredients that do work. Of the 11 supplements that market research shows were top-sellers, only four duplicated the AREDS formula.

 Moreover, most manufacturers didn’t bother to point out that the AREDS results don’t pertain to everyone with macular degeneration, and that therefore some consumers won’t benefit from these products."

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2013 warning letters: NDIs, beverage vs supplement, and brand holders' obligations among important themes

2013 warning letters: NDIs, beverage vs supplement, and brand holders' obligations among important themes:

"Some themes that can be gleaned from 2013’s warning letters are part of a constant drumbeat.  Firms are cited by FDA for basic GMP violations and for making non-compliant disease claims on their products.  But other themes, while perhaps not new per se, have acquired a renewed emphasis in the last year, Prochnow said, including the following:" . . .

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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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GMP Success Tips For Dietary Supplements

Image via WikipediaHere's a short and sweet digestible tip sheet, from Chromadex, on how to successfully tackle the FDA GMPs for Dietary Supplements, Dietary Supplement cGMP Highlights and Tips for Success - Tech Tip 0014 (PDF) 

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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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The Real Vitamin and Mineral Book, 4th edition: The Definitive Guide to Designing Your Personal Supplement Program

Free GMP Webinar on Dietary Supplements - May 5, 2010

The implementation of FDA GMP rules for dietary supplements is coming fast. Nutricap Labs is partnering with Natural Foods Merchandiser magazine to present a free webinar entitled, Will Your Supplement Shelves Be Ready? Understanding the Retail Impact of the June GMPs (registration form).

The webinar will cover:

• What the June GMP’s will entail
• How these regulations will impact the current state of the dietary supplement manufacturing industry
• Choosing between custom manufacturing versus private labeling
• Insider tips on how to select a GMP-certified manufacturer

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Multivitamins Seem Benign, Maybe Beneficial

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Updated October 21, 2021

A link in the original post broke.

You might also be interested in:

Information for Consumers on Using Dietary Supplements - FDA.gov

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We might never really know for sure in my lifetime. I take them because I think my diet isn't diverse enough.

In any event, here's an interesting read published by the Washington Post, Evidence is thin that multivitamins are beneficial, but they seem benign. 

Learn more about vitamins:
- in this FDA video, Fortify Your Knowledge About Vitamins (video)
- read this book, The Complete Idiot's Guide to Vitamins and Minerals, 3rd Edition

Do you take them? ... and why?

#FDA #GMP #training #cGMP

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FDA - June 2009 Supplement Manufacturer Compliance

The federal government is taking a tiered approach to enforcement: companies with more than 500 employees were required to become GMP (good manufacturing practices) compliant by June 2008; companies with 21-499 employees must become compliant before June 2009; and companies with fewer than 20 employees will need to be compliant by 2010, according to this Lab Science News post, New FDA Regulations for Dietary Supplements.

Well, June 2009 is upon is. Lorraine Heller reports that with two weeks to go before mid-sized supplement firms need to comply with new GMPs, the US Food and Drug Administration (FDA) has said it aims to inspect 200 facilities this fiscal year, in her post, FDA aims for 200 GMP inspection this year.

Time is up, and here are some additional references:
FDA Issues Dietary Supplements Final Rule
FDA 21 CFR part 111

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Should The FDA Oversee Nanotechnology Dietary Supplements?

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Updated October 15, 2022:

Some links broke.

You might also be interested in:

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

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If you read this Project On Emerging Nanotechnologies publication, you'll probably say yes, A Hard Pill to Swallow - Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements. Historically, the regulation of dietary supplements has been a significant challenge for the U.S. Food and Drug Administration (FDA), and the fact that some of these products are now being manufactured using nanotechnology creates an additional layer of complexity. The use of engineered nanoparticles in dietary supplements raises serious questions about whether such products are safe. Congress has generally allowed dietary supplements to be marketed without any pre-market demonstration of safety, based largely on the assumption that these products have been used for many years. There is, however, no basis for concluding that dietary supplements containing engineered nanoparticles are safe. The authors ask, "Is FDA equipped to meet the emerging regulatory challenge of dietary supplements that use engineered nanomaterials?" Here's their conclusion . . .

• There is no basis for concluding that dietary supplements containing engineered nanoparticles are safe.
• While it is not possible to determine the prevalence of dietary supplements containing engineered nanoparticles, it is likely that the public’s exposure to these products will grow significantly in the next several years. Congress should adopt legislation granting FDA the authority to collect additional information about these products and to ensure that they are tested for their effects on human health. Such legislation should prohibit the sale of new dietary supplements containing engineered nanoparticles until they have been demonstrated to be safe, and it should provide FDA with sufficient resources to regulate these products.
• Until Congress acts, consumers who take dietary supplements containing engineered nanoparticles will be at additional, unknowable, and potentially serious risk.

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Caution - Some Dietary Supplements Contain Hidden Drugs

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Updated November 19, 2020

Links broke in the original post.

You might also like to read:

Feature: Revealing the hidden dangers of dietary supplements - ScienceMag

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Things aren't always what they seem to be. The same goes for some dietary supplements. An estimated 150 million Americans use dietary supplements, ranging from multivitamins to herbal remedies to specialized mineral blends. So folks need to be careful about what they buy and who they buy it from, reports this Atlanta Journal Constitution article, "Dietary pills laced with drugs - After-market scrutiny: FDA warns about Blue Steel, other supplements that do not have to prove their safety." The government estimates that 30,000 to 40,000 supplement products are being sold by all sorts of companies, some large and reputable, others operating out of a garage or basement. This poses a challenge because regulators are spread too thin, and can only conduct occasional spot checks. Here are some resources that you can reference to try and protect yourself . . . Dietary pills laced with drugs - After-market scrutiny: FDA warns about Blue Steel, other supplements that do not have to prove their safety (audio) 

Resources: 

FDA: Recalls & Safety Alerts for dietary supplements and other products 

FDA: Risks of buying fake erectile dysfunction products on the Internet 

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How The FDA Regulates Botanical Drugs

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You have to read this. In an issue of Nature Biotechnology, you'll learn how FDA personnel review applications to test botanical drugs in humans, and market those products in the US as reported in this article, "New therapies from old medicines - Although new botanical drugs pose many challenges for both industry and the FDA, approval of the first botanical prescription drug shows they can be successfully met (pdf)." In general, here's what it's all about . . .

1. From dietary supplements to new drugs
2. Current US regulatory environment
3. Review of botanical applications at CDER
4. Analysis of botanical drug IND submissions
5. Unique regulatory issues
6. Botanicals as variable, complex mixtures
7. Botanicals as multiple-plant combinations
8. Previous human use of botanicals
9. Botanicals marketed as dietary supplements

It's encouraging to me to see these kinds of articles appearing on the topic. Personally, I'd consider using more botanicals if I can see that some form of rigor is applied to them.

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FDA 101: Dietary Supplements - Things you should know

Updated May 2, 2024

Read this to learn more about dietary supplements. This is another perfect example of how drugs, prescriptions, and dietary supplements intersect the FDA GMPs (good manufacturing practices). According to the FDA, in "FDA 101: Dietary Supplements," ... "The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet." You might want to be concerned if you have certain health conditions, because in some instances, if you take these products, you may be putting yourself at risk. The article recommends consulting a health professional if this is your situation. The major topics covered are: talk with a healthcare professional; how are supplements regulated; are supplements safe; be a safe and informed consumer.

The FDA is involved because it stipulates some regulations. For example, "in general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded."

Additional resources on dietary supplements:

1. Final Rule Promotes Safe Use of Dietary Supplements - another free consumer-oriented FDA article
2. The final rule on CGMPs for dietary supplements - available free on the FDA website, these regulations will interest manufacturers
   

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Free Podcasts - About Herbs and Dietary Supplements

Updated August 17, 2021

The links in the original post broke.

You can still learn more about this topic here:

Weight Loss Dietary Supplements and The Pursuit of Happiness (video) - YouTube. Lecture by Candy Tsourounis, Professor of Clinical Pharmacy UCSF

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Good stuff! A surprising find. Quite by accident, I found a collection of free podcasts produced by UCSF (University of California, San Francisco), my alma mater. This collection is a series of podcasts from a Candy Tsourounis taught pharmacy school course focused on An Evidence Based Review on Herbs and Dietary Supplements. This is a great example of technology making knowledge sharing so accessible to the general public. Follow the link above, and you'll discover 5 podcasts . . .

1. The Dietary Supplement Industry - An Overview
2. Herbs and Supplements in Mental Health
3. Supplements and the Immune System, Herbal Remedies for Immune Function
4. Weight Loss Supplements
5. Glucosamines, Omega 3 Fatty Acids

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