FDA Issues Long-Awaited Revised Dietary Supplement NDI Draft Guidance: FDA Law Blog

FDA Law Blog: FDA Issues Long-Awaited Revised Dietary Supplement NDI Draft Guidance:

"Last week, FDA issued for the dietary supplement industry a draft guidance document that largely doubles-down on controversial positions the Agency has previously taken. The draft guidance – “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” – replaces the draft of the same name that was issued in July 2011."

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Read the FDA guidance:
Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry - Draft Guidance (PDF)

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CRN FDA GMP Warning Letter Database - For Dietary Supplements - Free

Read the full press release: CRN FDA GMP Warning Letter Database Document:

"The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, today announced a free online tool that compiles FDA Warning Letters sent to dietary supplement companies into a searchable database to help industry achieve better regulatory compliance. The database can be used to evaluate FDA’s warning letter allegations of good manufacturing practices (GMPs) violations, products making impermissible claims, and products tainted with illegal ingredients."

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Access the CRN FDA Warning Letters Database for Dietary Supplements

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Quality of Dietary Supplements - QM USP

Updated Mar 24, 2023

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Dietary Supplements - USP Quality Matters

---  the original post follows below  ---

Read the full article: Quality of Dietary Supplements - QM (Quality Matters) USP:

"In the United States, current Good Manufacturing Practices (cGMPs) for dietary supplements are mandated by law, and the FDA has the authority to oversee dietary supplement companies for compliance with those GMPs. This provision of the law acts to safeguard consumers of some quality issues, helping to keep dietary supplements from becoming adulterated.

However, most quality specifications for dietary supplements in the United States are set by manufacturers with no premarketing oversight and few uniform requirements. For that reason, the quality of dietary supplements may vary significantly from one manufacturer to another.

Moreover, dietary supplements and their ingredients may be manufactured in countries with weaker regulatory systems making it even more difficult to control the quality of dietary supplements imported into our domestic market."

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Dietary Supplement Manufacturer Audit Preparation - NPI

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Read the full article: Dietary Supplement Manufacturer Audit Preparation - NPI:

"Common Mistakes Auditors Find

Recent GMP audits reveal companies failure to perform tasks in two main areas:

Quality Issues

• Perform required identity testing on incoming dietary ingredients raw materials
• Set appropriate specifications for raw materials, components and finished good product
• Perform finished good product testing confirming identity, strength and composition
• Lack of finished product release criteria (does finished batch conform to product spec?)
• Adopt written procedures (e.g., SOPs)
• Prepare and follow master manufacturing records (MMR) and/or batch production records (BPRs) for manufacture of dietary supplements (with formulation and batch size)
• Document corrective actions undertaken
• To conduct required material reviews and make disposition decisions

Facility Issues

• Physical plant design
• Sanitation requirements of the physical plant and associated grounds
• Issues with manufacturing equipment and utensils"

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One third of Americans mixing supplements with meds: study | Reuters

One third of Americans mixing supplements with meds: study | Reuters:

"“Multivitamins are commonly assumed to be safe, but our analysis suggests multivitamins, which may include multivitamin ‘plus’ combination products, can also contain botanical and herbal ingredients that have the potential to interact with prescription medications,” Harris Lieberman told Reuters Health in an email."

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FDA: For Women > Dietary Supplements: Tips for Women

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For Women > Dietary Supplements: Tips for Women - FDA:

"Dietary supplements are products that people add to their diets. They include vitamins, minerals, herbs, and amino acids. They can be pills, liquids, powders or energy bars.

Although dietary supplements can help support good health, they may also cause side effects and health problems. It is important to think about the health benefits and risks before taking any product.

Tips for Women
Anyone can have problems with dietary supplements. Some women need to take special steps to stay safe."

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FDA Finalizes 2009 Draft Guidance on Distinguishing Liquid Dietary Supplements from Beverages - FDA Law Blog

FDA Law Blog: FDA Finalizes 2009 Draft Guidance on Distinguishing Liquid Dietary Supplements from Beverages:

"Compared to the 2009 draft guidance, the final guidance “Distinguishing Liquid Dietary Supplements from Beverages” provides considerably more information, including specific examples, on the factors FDA considers when determining whether the product is a conventional food or a dietary supplement.  As mentioned in the draft guidance, FDA considers labeling and advertising, product name, product packaging, serving size and recommended daily intake, directions for use, marketing practices and composition.  Where the draft guidance merely listed these factors, the final guidance discusses each factor and provides specific examples."

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The two new guidances:
Distinguishing Liquid Dietary Supplements from Beverages (PDF)
Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplement (PDF)

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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

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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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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 - Don't Represent Dietary Supplements As Foods

FDA: Dietary Supplements Can't be Marketed as Foods:

" . . . If nothing else, it is a very good reminder that you must be extremely careful making any representations about your product, not just the claims on the label," Prochnow said in an email Tuesday to the media. "Claims on websites and in other marketing and advertising can and will be used by FDA as evidence of the company's true intent to sell the product.""

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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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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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GAO Makes Dietary Supplements AERs Recommendations to FDA

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U.S. GAO - Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products:

GAO recommends, among other things, that FDA explore options to obtain poison center data, if determined to be useful; collect information on how it uses AERs; provide more information to the public about AERs; and establish a time frame to finalize guidance related to GAO's 2009 recommendations. FDA generally concurred with each of GAO's recommendations.

Read the full GAO Report (PDF):
DIETARY SUPPLEMENTS - FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products

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FDA Seizes Illegal Dietary Supplements in FL

FDA Seizes Illegal Dietary Supplements in FL | Designated Representative and Exemptee:

"WASHINGTON: FDA seizes illegal dietary supplements in Florida - Business Breaking News - MiamiHerald.com:

"Several of the supplements from Globe All Wellness LLC contain the active ingredient in Meridia, a weight loss drug that was withdrawn from the market in 2010. The drug was pulled after studies showed it could increase the risk of heart attack and stroke.

Among other problems, the Hollywood, Florida-based company made unsubstantiated claims about the benefits of its products and did not comply with manufacturing standards."

For additional details:
FDA Warning Letters - Globe All Wellness, LLC 2/6/12

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Related articles

• Titan Medical Enterprises Shut Down for GMP Violations (drughealth.blogspot.com)

Titan Medical Enterprises Shut Down for GMP Violations

Press Announcements > Court shuts down U.S. operations of California drug, dietary supplement manufacturer:

"The court found that the company and McDaniel violated the Act by failing to follow current Good Manufacturing Practice for drugs (Drug cGMP) and for dietary supplements (Dietary Supplement cGMP). The court also found that the defendants violated federal law by distributing unapproved new drugs in violation of the Act. Prior to entry of the court’s order, Titan Medical Enterprises manufactured and domestically distributed a variety of drugs and dietary supplements."   . . .

Drug cGMP includes practices and systems required to be adopted in the manufacture and testing of pharmaceuticals. Drug cGMP outlines the aspects of production and testing that can impact the quality of a product.

Similarly, Dietary Supplement cGMP regulations require dietary supplement manufacturers to ensure quality in their dietary supplements by appropriately controlling all aspects of their processes and procedures to ensure a supplement meets minimal quality standards and is not adulterated by the presence of contaminants.

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FDA Inspection - Tips by the FDAzilla Blog

A good quick primer with some useful links to resources . . .

» 20 Resources to Ace Your Next FDA Inspection FDAzilla Blog:

"FDA inspections.  If part of your job includes preparing your cGMP manufacturing facility to be ready at any second for an FDA inspection.  This page is for you.  Here are our top 20 resources and FAQs for you: . . ."

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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: . . ."

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

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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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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• FDA Sends Out 10 Warning Letters to Dietary Supplement Manufacturers

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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.

- - -  the original post follows below  - - -

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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