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FDA Chief Scott Gottlieb resigns


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#1 FoodSafetyPlanet

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Posted 05 March 2019 - 10:53 PM

https://www.bloomber...-said-to-resign

 

Thoughts? I wonder if part of this had to do with the backlash he received over recalls. 



#2 MsMars

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Posted 11 March 2019 - 06:01 PM

It appears to be a combination of personal and professional factors. However, I haven't read any news articles linking his resignation in any way to food-related recalls. One can only speculate...



#3 mgourley

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Posted 11 March 2019 - 09:09 PM

I'm enough of a cynic to state that the resignation of a bureaucrat really does not matter. 
If the FDA is doing it's job, who "runs" it, really does not matter. 

 

That being said, the FDA does not have anything directly to do with recalls. Breakdowns in food manufacturers systems directly impact recalls.

The FDA can tell business what they have to do, they can't run the business. Nor should they.

 

Marshall



#4 Charles.C

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Posted 12 March 2019 - 08:55 AM

I'm enough of a cynic to state that the resignation of a bureaucrat really does not matter. 
If the FDA is doing it's job, who "runs" it, really does not matter. 

 

That being said, the FDA does not have anything directly to do with recalls. Breakdowns in food manufacturers systems directly impact recalls.

The FDA can tell business what they have to do, they can't run the business. Nor should they.

 

Marshall

 

Hi Marshall,

 

(slightly OT)

 

I have just been reading the FDA's justifications for launching the FSMA Epic.

 

Various of the "excuses" look remarkably similar to those given by FDA to justify the  launching of their HACCP System - "Seafood Final Rule".

 

"What goes around ......."

 

Unfortunately, IMO, not always in a Good Way.


Kind Regards,

 

Charles.C


#5 mgourley

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Posted 12 March 2019 - 11:40 AM

HI Charles,

 

Where can this fascinating reading be found?

 

Marshall



#6 FSQA

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Posted 12 March 2019 - 01:15 PM

Seems like his actions/restrictions against the tobacco (particularly e-ciggs/minor sales) industry took a toll on his position as an FDA Chief.



#7 Charles.C

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Posted 12 March 2019 - 03:54 PM

HI Charles,

 

Where can this fascinating reading be found?

 

Marshall

 

Hi Marshall,

 

I was browsing through some google books on FSMA (becoming a popular topic). Unfortunately I didn’t note the authors. Sorry.

 

However just as an example, here is a quote I just unearthed ex an FDA document (ca 2015) –

 

Before the passage of FSMA, performance standards have been an important means by which FDA has sought the end result of “safe food.”  Emphasis has been placed on verifying/monitoring the end result – the safety and sanitary production of the food that people consume -- rather than on the crucial need for industry to evaluate, institute and verify control measures to ensure that the introduction of hazards is prevented, conditions of manufacture are appropriate, and their products meet established food safety standards.  An exception to this is where FDA has required HACCP (juice and seafood).

 

Attached File  FDA-FSMA-Report-to-Congress (ca 2015).pdf   1.04MB   3 downloads

 

Compare this generic haccp comment (1994) which preceded FDA's Seafood Final Rule –

Few initiatives in the recent history of food safety regulation  have  approached  the  significance  of the  Hazard Analysis and Critical Control Point  (HACCP) system. The HACCP  concept  is  simple;  it  is  a  systematic,  proactive approach  to  preventing  food  safety  hazards  by  focusing resources  at  those  points  at  which  food  safety  hazards can  be  controlled,  an  alternative  to  generally  reactive end-product testing.

 

Attached File  HACCP,1995.pdf   4.85MB   2 downloads

 

Déjà vu indeed ! Suggests the query - Why 20 years ?

 

PS - I also noted this potentially intriguing 2017 comment -
https://www.fooddive...recalls/440539/

When looking at the recalls that have occurred since FSMA went into effect, it’s important to note that many of them were not caused by the types of problems that FSMA is intended to stop. Food products can be recalled for contamination from bacteria or pathogens, but there are other reasons as well.

“Recalls are not just for contamination by bacteria,” Sandra Eskin, director of food safety policy at the Pew Charitable Trusts, told Food Dive. “They’re for allergens, and that’s a huge part. …There are pieces of plastic or metal, or some other contaminant.”

 

Undeclared allergens — food products containing things like dairy, soy, nuts, peanuts, gluten and eggs that aren’t on the label — lead the list of reasons why food products are recalled.  Food Safety News reported that roughly since the beginning of February, 43% of all FDA food recalls have been due to this sort of labeling issue. In terms of USDA recalls, there were more related to undeclared allergens than salmonella, E. coli and listeria combined last year. These problems occur through mislabeling or equipment-sharing issues, which FSMA was not designed to correct.

 


Kind Regards,

 

Charles.C


#8 Scampi

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Posted 12 March 2019 - 04:46 PM

 

 

Déjà vu indeed ! Suggests the query - Why 20 years ?

 

 

What is stranger still is that the basic HACCP system was initially developed for NASA............so why abandon it for 40 years?!?!?!? And then why re-write as something else altogether???  What did the department of defense not give the research to the FDA?  

 

https://safefoodalli...story-of-haccp/

 

Seriously, 1972.................


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#9 Hank Major

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Posted 13 March 2019 - 06:58 PM

It almost certainly has to do with the vaping and flavoring in the tobacco issues, not food.



#10 Scampi

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Posted 13 March 2019 - 07:03 PM

I've never understood having 1 body responsible for medical devices, tobacco and food..................spread too thin with too many priorities


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#11 bakeryscience

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Posted 13 March 2019 - 08:07 PM

I've never understood having 1 body responsible for medical devices, tobacco and food..................spread too thin with too many priorities

 

 

Cosmetics, too! 



#12 mgourley

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Posted 13 March 2019 - 08:08 PM

Charles,

 

One wonders why they did not just mandate Seafood/Juice HACCP type requirements for the entire industry?

Facilities that run under Seafood/Juice HACCP are exempt from the food safety plan requirements of FSMA.

 

The last quote is dead on. Even after all these years of recalls because of allergen/labeling issues, it's still the number one reason for recalls in the USA.

FSMA does a few good prescriptive things on allergens.

 

Marshall



#13 mgourley

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Posted 13 March 2019 - 08:09 PM

I've never understood having 1 body responsible for medical devices, tobacco and food..................spread too thin with too many priorities

 

Food, Drug and Cosmetic Act of 1938

Marshall






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