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Over Half of Dietary Supplement Manufacturing Facilities Fail FDA Inspections

dietary supplements supplement quality dshea

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#1 Michael

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Posted 01 June 2019 - 09:52 PM


All:
 
FDA struggled for years to get current Good Manufacturing Procedures (cGMP) regulations passed as required under DSHEA, with constant pushback from the industry. Since they were more or less finalized in 2007, there have been reports year after year that more than half of inspected manufacturing facilities have failed: for instance, in 2012, the Chicago Tribune reported that
 

In the last four years, the U.S. Food and Drug Administration has found violations of manufacturing rules in half of the nearly 450 dietary supplement firms it has inspected, according to agency officials.
 
The inspection reports portray an industry struggling to meet basic manufacturing standards, from verifying the identity of the ingredients that go into its products to inspecting finished batches of supplements.
 
Some firms don’t even have recipes, known as master manufacturing records, for their products.
 
Others make their supplements in unsanitary factories. New Jersey-based Quality Formulation Laboratories produced protein powder mixes and other supplements in a facility infested with rodents, rodent feces and urine, according to government records. FDA inspectors found a rodent apparently cut in half next to a scoop, according to a 2008 inspection report.
 
“It’s downright scary,” said Daniel Fabricant, head of the FDA’s Division of Dietary Supplement Programs. “At least half of industry is failing on its face.”
 
The FDA began conducting inspections in 2008 to assess compliance with new regulations governing the manufacturing, packing and holding of dietary supplements. Since then, 1 in 4 dietary supplement companies inspected by the agency have received a warning letter, considered a significant enforcement action.
 
So far this year, FDA inspectors have found violations of good manufacturing practices during two-thirds of the 204 inspections they have conducted in nearly 200 supplement firms’ facilities, agency officials said. Seventy of these inspections resulted in the agency’s most serious rating.

 
In 2015, as reported by a dietary supplements trade publication (not some extremist anti-supplement organization),
 

FDA Still Finds Basic GMP Violations in Supplement Industry
 
For a number of years, FDA inspectors have continued to observe dietary supplement firms commit the same egregious violations of manufacturing regulations. Unfortunately, fiscal year 2015 was no different.
 
Nearly 19 percent of dietary supplement firms that were cited by inspectors for violations of the cGMPs (current good manufacturing practices) allegedly failed to set specifications for the identity, purity, strength and composition of the finished product, INSIDER learned through a Freedom of Information Act (FOIA) request. About 16 percent of firms that were issued a document for violations of cGMPs, or 46 total inspections, failed to verify the identity of a dietary ingredient through an appropriate test or exam, according to the FDA data. ...
 
FY15 cGMP inspections: 483
Reinspections: 63
Form 483s issued [Warning Letters documenting substantial inspection failure]: 281 [That is, [281/(483-63)]= 67% of inspected facilities failed inspection]
Total observations: 1,437
Average number of observations: 5.1
Most common observation: failure to establish product specifications
Dietary supplement facilities registered with FDA: 12,964 [that is, only about a third of facilities inspected at all]
Source: FDA


 ... and now we know that still, in 2018:
 

Harvard Medical School professor criticizes FDA drop in dietary supplement inspections
... FDA data shows the agency conducted 591 inspections in fiscal year 2018 (FY18) for compliance with cGMPs (current good manufacturing practices), regulations FDA adopted more than a decade ago. That’s down from 656 inspections the previous year.
 
Of the total inspections in FY18, 317—or 54 percent—received a document (Form 483) alleging violations of the cGMPs, according to FDA data INSIDER obtained through a Freedom of Information Act request. In the previous year, 379 inspections—or 58 percent—were cited for alleged infractions or “observations,” FDA data shows.

Dietary supplement cGMPs: By the numbers
FY18 inspections: 591
Firms issued Form 483: 317
Average number of inspections per 483: 5.12
Most common “observation”: You did not establish product specifications for identity, purity, strength and composition of finished dietary supplement (75 inspections/23.66 percent of inspections issued 483).
Source: FDA based on response to Freedom of Information Act request.

 
“The dietary supplement cGMP regulation has been in effect for about 10 years, and the overall level of industry-wide compliance that we observe during inspections is still well below where it needs to be,” Steven Tave, director of FDA’s Office of Dietary Supplement Programs, said in an emailed statement. “We continue to see fundamental deficiencies, and our compliance and enforcement activity, including recalls, warning letters and judicial actions, reflects that reality. This is a state of affairs that has to improve.”
Nonetheless, Tave recognized “many firms are, for the most part, getting it right.” ...
 
Corinne Newhart, an FDA spokeswoman, said ... “Generally speaking, dietary supplement firms are inspected every three years or five years, depending on whether they are considered to be high risk,” she explained in an email....
 
Under FSMA, high-risk facilities must be inspected every three years. But each year, FDA only inspects a fraction of the total number of registered facilities. According to a presentation from an FDA official, there were 9,300 registered dietary supplement facilities in FY17. [So only 6% of facilities were even inspected!].
 
Potentially complicating matters for FDA, new entrants regularly venture into the dietary supplement market, while others merge or go out of business.
“There’s a lot of new companies,” Marian Boardley, an independent cGMP consultant, said in an interview. “Companies get bought. Companies get sold. They get merged. They go bankrupt.”
Larisa Pavlick is a former FDA investigator who inspected dietary supplement facilities for compliance with cGMPs in the Denver District. She has firsthand experience dealing with the agency’s competing priorities and limited resources.
“Just from a management perspective, when you only have one handful of investigators to apply to the entire food industry, the resources are not being placed in the supplement area, especially when there’s outbreaks,” said Pavlick, vice president of global regulatory and compliance with the United Natural Products Alliance (UNPA). “Everyone gets pulled into whatever the emergency or outbreak is and managing those versus the routine work that might [be devoted to] the supplement GMPs.”


 

FDA still finding same cGMP deficiencies at dietary supplement facilities

... In fiscal year 2018 (FY18), 75 inspections—or about 24 percent of firms that received a Form 483 inspection report for “observations,” or alleged cGMP violations—were cited for failing to establish product specifications for the identity, purity, strength and composition of the finished dietary supplement, FDA data revealed. This was the most common cGMP observation in FY18 year as well as in FY17 when 24 percent of firms (89 inspections) were cited for the same infraction, according to FDA data INSIDER obtained through the Freedom of Information Act (FOIA).

Over the years, FDA has repeatedly emphasized the importance of setting and following specifications for the identity and other key attributes of a dietary supplement. Without doing so, FDA and outside cGMP consultants have said, manufacturers have no reliable way to know and verify what is in their products.

Nearly half (274 inspections, or 46 percent) of the 591 inspections in FY18 didn’t receive a Form 483, which suggests those dietary supplement manufacturing facilities are fully compliant with the cGMPs. [MR: actually, no, it doesn't: it means that 46% of facilities did not have infractions serious or persistent enough to trigger a Form 483 Warning Letter]. ...

Through the first nine months of 2018, FDA most commonly cited dietary supplement firms in warning letters for failing to establish and follow written procedures for the responsibilities of quality control operations. In FY18 Form 483s, the latter cGMP infraction was the second most cited cGMP observation (52 inspections, representing around 16 percent of all Form 483s).
In the previous three years, the most common cGMP violation reported in FDA warning letters was related to specifications to establish when devising a production and process control system, NPA reported this week in a chart within a news release. The above infraction dropped to the third most-cited cGMP violation in 2018 warning letters, while the second most commonly cited infraction related to recordkeeping requirements for production and process control systems.

Written Procedures and Recordkeeping
Daniel Fabricant, Ph.D., president and CEO of NPA, didn’t seem surprised that many cGMP infractions in 2018 warning letters related to written procedures and recordkeeping. The point of a GMP rule, he said in an interview Wednesday, is to ensure safety and consistency in the manufacturing of products. ...

“We know they’re [FDA investigators] not going to be everywhere,” Fabricant, who previously oversaw FDA’s Division (now an office) of Dietary Supplement Programs, said. “But what’s the number they have to conduct to at least ensure a baseline level of compliance? That’s the question I think that still remains unanswered.”
He asked, “[i]f FDA’s only getting to 5 percent of the firms out there, 10 percent of the firms, is that truly enough to deter bad behavior when it comes to manufacturing quality?”


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#2 Mind

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Posted 02 June 2019 - 09:43 AM

Not easy to find the actual FDA record of inspections. Anyone know where to find that? It would be good to know the percentage of companies failing for contamination vs. poor record-keeping.


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#3 Michael

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Posted 02 June 2019 - 03:33 PM

Not easy to find the actual FDA record of inspections. Anyone know where to find that? It would be good to know the percentage of companies failing for contamination vs. poor record-keeping.

They don't actually publish inspection records, unfortunately (company privacy, preliminary, blah blah): only Warning Letters. I have found no good central database of these: FDA itself either doesn't have one or has them pretty darned buried, and while the misnamed Council for Responsible Nutrition (the biggest dietary supplement trade group) has a what they call a database of such records, it's woefully incomplete, with only three Warning Letters in the last two years (!).
 
If you Google:
"dietary supplements" OR dshea "warning letter"
 
or
 
"warning letter" [company name]
 
You can get a bunch, with some false positives — but not nicely organized, and clearly also incomplete.
 
I wouldn't dismiss "poor record-keeping," by the way. Modern QC, post the 1993 Jack in the Box E. coli disaster, relies almost entirely on rigorous paper trails of procedures enacted and followed, whether it's HACCP for ground beef or cGMPs for dietary supplements. First, if a company can't even keep good records, is it really likely they're taking good care to (for instance) consistently properly calculate out and disperse potentially toxic ingredients at teensy-tinesy doses in complex products, like vitamin A or selenium in a multivitamin?  Second, unless you have a whistle-bower or a hidden camera, how would you know a company is doing no testing or the wrong testing or is letting its employees walk around without protective gear unless you have a paper trail to document it? The alternative wold be to get FDA to independently test every batch of every product for active ingredients and multiple potential contaminants during a random one-week period or something — not very damned likely. The budget for FDA's dietary supplement division is woefully inadequate as it is. There's a reason why ConsumerLab has so few entries for any given product, despite changing both companies and consumers for their service.


Edited by Michael, 02 June 2019 - 03:46 PM.


#4 Michael

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Posted 16 June 2019 - 04:02 PM

 

Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices
June 14, 2019

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized more than 300,000 containers of dietary supplements, including tablets, capsules, and teas from Life Rising Corporation. The seized goods ... consisted of more than 500 products bearing brand names Life Rising, Holicare, or HopeStream, and are valued at approximately $3.5 million. The U.S. District Court for the Northern District of Illinois determined there was probable cause that the company prepared, packed, and/or held dietary supplements under conditions that do not conform to the dietary supplement current good manufacturing practice (CGMP) requirements.   ...

 

Among other observed deficiencies, the company failed to establish product specifications for the identity, purity, strength, and composition of each finished batch of dietary supplement, and for limits on certain types of contamination, to ensure the quality of the supplement. The company also lacked written procedures for pest control and for maintaining, cleaning, and sanitizing equipment and/or surfaces that came in contact with the dietary supplements, among other violations. Based on these CGMP violations, last month, the FDA issued an Administrative Detention Order to prevent these products from reaching consumers until they could be seized.

 

Last month, the FDA also issued a safety alert for three Life Rising products (Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets) because those products may be contaminated with lead. These products were recalled by the company on May 2, just before the FDA’s safety alert.  ...

 

In 2016, Life Rising recalled certain dietary supplement products because of elevated lead levels, and in May 2017, the agency issued a warning letter to Life Rising citing CGMP violations. This action stems from a follow up inspection the FDA conducted to evaluate the company’s CGMP compliance. In light of the recalls and safety alerts, as well as the continuing violations of CGMP, the FDA discourages consumers from purchasing or using dietary supplement products bearing brand names Life Rising, Holicare, or HopeStream.

 


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#5 Rocket

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Posted 18 June 2019 - 01:44 PM

The government can find fault with anything it wants to, that's how these people continue to have jobs. I am positive that the muscle building supplements I have consumed, their production facility wouldn't pass an inspection by the even Mexican government, yet they worked and worked well.


Edited by Rocket, 18 June 2019 - 01:45 PM.

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#6 Phoebus

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Posted 18 June 2019 - 02:06 PM

The government can find fault with anything it wants to, that's how these people continue to have jobs. I am positive that the muscle building supplements I have consumed, their production facility wouldn't pass an inspection by the even Mexican government, yet they worked and worked well.

 

 

Thank you John Galt for you input 


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#7 Andey

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Posted 18 June 2019 - 05:06 PM

>FDA struggled for years to get current Good Manufacturing Procedures (cGMP) regulations passed as required under DSHEA, with constant pushback from the industry.

 

I believe at least Swanson an Jarrow claim that they are cGMP compliant so should be a safe bet in the economy department. 


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#8 Michael

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Posted 18 June 2019 - 07:02 PM

>FDA struggled for years to get current Good Manufacturing Procedures (cGMP) regulations passed as required under DSHEA, with constant pushback from the industry.

 

I believe at least Swanson an Jarrow claim that they are cGMP compliant so should be a safe bet in the economy department. 

 

While in absolutely no way casting aspersions on either of these companies (who I believe to be reliable), I would not put any stock into a claim of cGMP compliance, which as of 2008 simply amounts to saying "we are not violating the law." It's quite clear that a lot of companies asserting this are simply lying, which is cheap and easy to do. Look instead for an outside cGMP compliance certification body, such as UL, NSF, or USP, and/or for other signs of diligence and quality such as I suggested here:

 

 

having been around for a while; showing scientific literacy and modesty in their marketing materials; have passed some third-party testing (CL, Labdoor, Consumer Reports, occasional media exposés, etc); ... being willing to share third-party certificates of analysis; having easily-found US/Canada/EU address and contact information, and being responsive to inquiries; not having FDA Warning Letters (like this) against them; having non-deceptive Supplement Facts and related info (like not playing fast-and-loose with serving sizes or elemental values); and even having professional-looking  labels and packaging (if they can't even invest in a decent label, how can they run a clean production facility?).

 

I'm not saying they should tick all of these boxes, but those are all things I look at and consider valuable.


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#9 GABAergic

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Posted 20 June 2019 - 01:21 AM

im pretty sure even if companies that did pass inspection doesnt guarantee that they will continue to do well in the future. its a gamble when you buy and use supplements all the time. there might be just that one bad batch that can poison or kill you, most likely waste your money if not else. thanks to this, i have more reasons to quit all supplements. i just cant rely on someone else to make sure what i consume is good quality. for example some of those reliable companies mentioned, i had different batches of the same vitamin. they are getting their supply from china 90% of the time and its not that they are causing the problem, they have to rely on some chemical company in india or china not to fuck up and send them a different, perhaps toxic batch next time. im sure they wont waste money and time to test every single batch they purchase so how can you tell when they fuck up once? i sent email to dozen of "reliable" big name companies confirming they arent the ones manufacturing the product, but they admitted buying it mostly from china. so, suit yourself guys, but im thinking of quitting this supplement experiment


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#10 pamojja

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Posted 20 June 2019 - 10:37 AM

I'm more worried of food poisoning, by the sheer amount consumed each day.

 

But even after eating and supplementing Ayurvedic preparations each year on vacation in India, my yearly hair tissue mineral analysis didn't show any of the toxic metal raising. On the contrary, most decreased further within normal range. The only exception being Uranium, which rose after Fukushima above normal, but came down to normal the following years again.

 

In the end, supplements are just extracted components of foods and herbs. And only different from industrially produced foods, in that the amount of synthetic additives will be much much less.


Edited by pamojja, 20 June 2019 - 10:39 AM.


#11 Mind

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Posted 20 June 2019 - 05:02 PM

Remember there are companies that do independent testing. I recently interviewed Neil Thanedar of Labdoor: https://www.longecit...e&cat=all&pgn=2

 

They keep adding new supps and products to their list of testing: https://labdoor.com/


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#12 SomethingClever

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Posted 21 June 2019 - 05:06 PM

The government can find fault with anything it wants to, that's how these people continue to have jobs. I am positive that the muscle building supplements I have consumed, their production facility wouldn't pass an inspection by the even Mexican government, yet they worked and worked well.


That's probably what all those hatter's thought before they died of Mercury poisoning. Reminds me of that old joke of what the optimist says when he plummets off a skyscraper. "So far, so good!"
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#13 DrewMichael21

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Posted 21 June 2019 - 05:35 PM

1. The FDA regulation have been very lack-lust for quite a long-time. Their is so much corruption going on in the United States from regulatory agencies it's of no surprise that most nootropics and dietary supplements haven't been checked nor approved by the FDA. It's important to realize that capitalist companies will do the most cost-effective method of getting results at the cheapest price irrespective of how it could effect the consumer in the long run. Primarily, because capitalism is amoral in nature which I support still needs regulation to keep it in check. Honestly, I would have dissolved the FDA  long ago and other agencies because the US regulatory system needs to  a clean-house.  Obviously, that isn't going to happen until these old boomers die off, so new people can come in but it's unclear what should be done.


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#14 GABAergic

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Posted 21 June 2019 - 10:29 PM

its not just the supplements though. food as well. it seems in the US FDA allows more toxic chemicals on food than the european union. and the sad thing is they dont even regulate them either. https://www.nytimes....ted-states.html

so if someone like me decides to quit all supplements and just move to food, im still fucked.

check out the cosmetics section; https://www.theguard...s-restricted-eu

anyway, i give them props for finding out early on about the cancer causing impurities in blood pressure meds; https://www.webmd.co...recalls-2018-19 how the hell did they do that? im shocked. i would have thought it had to take its death toll to finally figure it out


Edited by GABAergic, 21 June 2019 - 10:30 PM.

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#15 pamojja

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Posted 22 June 2019 - 01:22 PM

so if someone like me decides to quit all supplements and just move to food, im still fucked.

 

I sadly rather get the impression you're loosing touch to reality, and descending into complete paranoia (click to enlarge)
 

UK_Relative_Risks_2D_2012_9_July_01.jpg
 
EU_Bubbles_Graph_2012_9_July_01.jpg

 

 

I'm more worried of food poisoning, by the sheer amount consumed each day.

 

I didn't say that to scare the rest out of you, but for you to being prepared to take the extra effort to avoid non-organically grown, processed and prepackaged foods. At least with the dirty dozens.


Edited by pamojja, 22 June 2019 - 01:25 PM.






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