Articles

2024

January The Long Reach of FDA Accusations

 

2023

September Day and Temp Labor Agencies, And Their Clients, Face Legal Changes
August Losing Agency
February Sustaining the Effort to Update Green Guides
January Other Shoe Finally Drops on Cosmetics Regulation

 

2022

December More Attention (Controversy?) for Food Packaging
October Oh, Those Wacky Food Labels
September On Contracts with Contract Packagers and Manufacturers
August Noodling on How to Arrange Regulator
July Single-use Plastics are Public Enemy #1 in California (Canada, too)
June GRAS Goes to Congress
May Contracts etc.
April A Healthy Try at Simplifying Food Labels?
March Changing Landscape
February Cannabis and CBD: Still. Holding. Breath.
January Cannabis and CBD: Still. Holding. Breath.

 

2021

December Here Come USDA’s “Bioengineered” Food Labels (or Maybe Not)
November One New Regulator, and Thoughts About All of Them
October Another Instructive Court Case, This One A Victory For Food Packagers
September What One Court Case Can Teach
August New Food Safety Blueprint: Threat or Opportunity?
July Pandemic’s Effects on Food Manufacturing, for Better or Worse, Could Linger
May Short But Important New Allergen Law
April Recycling on Everyone’s Radar
March A Chain of Changes
February Cannabis, CBD Sagas About to Get Real
January Import Tariffs Apply to One Thing or Another
January Food Fraud is Frequent, but Help Flourishes

 

2020

November Let’s Play Pundit
October Easier Said Than Regulated
October What do PFAS Actions Tell us About State Regulatory Officials?
September What Do PFAS Actions Tell Us About Food Contact Substances Industry?
July Why Would FDA’s Emergency Actions Stick Around After the Emergency is Over?
May We’re All Apart, and All Together
April Tales From the Front: Packaging Environment a Hotbed of Activity
March Updating the Nutrition Facts Panel: Easier Said Than Done, for Packagers and FDA
February Feds Say Not Legal, But Still It’s Not Rare: Why’s CBD for Sale Everywhere?
January You Are Wrong About Nutraceuticals, Functional Foods, and Dietary Supplements. But I Will Explain.

 

2019

December Laws and Norms Both Shape Policy
A 30-Year Development
November Caution: Environmental Pressures on Packaging Persist
October Food’s Identity Crises, Part II: Standard Stuff Gets Reconsidered
September Food’s Identity Crises
August Make Your Lawyer Happy: Plan Ahead
July Engineering a Mess
June Companies stay alert as there’s no obvious slowing at FDA
May Extended EPR may point directly at packaging
April Simple advice takes a complex regulatory path
April Packaging as team player
February ‘Meat’ the regulators who tackle the tough questions
January Packaging as cargo: out the door, but not out of mind

 

2018

December Despite lots of recall advice, companies often left wondering
November California’s Proposition 65: still weird after all these years
October How to vouch for products from here or there
September Undeclared allergens make foods misbranded and unsafe
August The ground has shifted, in a bad way
July On “bioengineered” disclosure specs, USDA proposes some, asks about others
June Regulators coordinate to protect kids from controversial products
May Food Fraud a Factor
April They’re Trying to Make Stewardship More Efficient
March When Regulators Turn to You For Help
February Late news is good news
January Surprise: cosmetics regulation may increase

 

2017

December How and why to revoke a reg
November Usually packages are filled that way for good, and lawful, reasons
October How packaging leaves its mark
September No, the message is the message
August To read FDA, see numbers, sure, but also new commissioner
July NGO actions may have real consequences
June States burdening packagers, while feds move toward burdening regulators
May What does a packager mean by sell by, use by, or best by?
April California’s Proposition 65 says ‘jump’ again, companies work through how high
March Radical regulatory reform a reality?
February I’d rather be wrong
January Here comes sugar, packagers

 

2016

December When government screws up, sorry, you usually can’t sue them
November Do as I Guide, Do as I Regulate
October Proposal Pounds Packaging and Would Pulverize Present Program
September GMO tail wags dog, then dog bites tail – but what’s next?
August Cracks in the foundation of FDA enforcement?
July Thinking behind the box
June The future, and present, of packaging substance regulation
May

 

Vermont’s tail (state GMO law) might wag the national dog
April You’re the new head of FDA? Um, congratulations
March All foodborne illness is local – or much of it, anyway
February FDA un-regulates pizza packaging products: A good example or a bad one?
January SmartLabels™ link technologies, and controversies

 

2015

December It’s natural to want a clearer definition
November So, I guess some drug ads are, like, totally regulated, whatever
October Food safety regulations are a growth industry
September Animal product regulation is a complex creature
August Trim the fat, cut the GRAS?
July Pot marketers eating up opportunities, shaping regulation
June GMO foods and labels: many angles, many squabbles
May Updating nanotech a little
April Regulators have a range of approaches
March BPA good news doesn’t end the story

 

February Sunscreens: follow FDA specs or get burned
January A rose by any other name would still be regulated by FDA

 

2014

December Packaging and its partners
November An interesting rulemaking, if you like that sort of thing
October Eye-opening developments in chemical safety
September Dude! Gluten rules!
August Poison packaging is an ongoing process
July Pondering packaging possibilities for pot products
June Food reports still here, getting tougher
May OTC drug packagers: FDA mulls changes to unique program
April Food Label Changes Invoke Nutrition, Health, History
March Food fraud (and related issues) to the forefront
February FDA wants trans fats out of food, but what else?
January Off-label uses: some can talk about them, some cannot, and somethings gotta give

 

2013

December Rules are rules and are a lot of work
November Food label needs both simplification and more detailed rules, some say
October Industry wins a Proposition 65 battle but more ahead
September BPA: Is it a complex story? Oh baby
August Are cosmetics regs getting a makeover?
July Cant avoid thinking globally
June Keep staring at the stats until they tell you something
May Generally recognized as controversial
March When Peanuts Are Tea Leaves
February New Pom decision plays different tune
January Food safety regulation shoes keep dropping

 

2012

December Election Day 2012 is over, but a couple of questions remain
November Green package, product guides attempt to be current
October Polishing the image of processed food and its packaging
September OSHA oversight also plagues packagers
August Whether freptovin or GMOs, controversies follow patterns
July News from the town square
June Food safety powers you might have forgotten about
May Cosmetics legal changes on the way?
April Read ’em and wonder: FDA enforcement stats are here

 

2011

December Nano policies still emerging there and here
November Proudly proclaiming packaging’s praises pushes public policy
October BPA gets into court, too
September Why is gluten like BPA?
August When packagers go international, compliance comes along
July Nano Steps
June Combination products challenge categories
May FDA enforcement stats and your job
April Everyone’s looking at you, kid
March Food safety law is here, and so are some of its effects
February Food safety law makes one wonder

 

2010

December Green Guides for packaging and products get an update but still have gaps
November Why BPA signs still point in different directions
October Tense trends tend to send messages to packaging makers
September California chemicals law still causing headaches
August Imported food still largely undiscovered territory
June Slack fill complaint leads to empty feeling
May Warnings show food labels are a new FDA priority
March HACCP advice for packaging makers

 

2009

November Chemical burdens tightening: Here comes EPA
October When packaging and labeling help fight drug counterfeits
September New Duty to report dangerous foods
August Surprise! Tobacco products get their butts kicked
July When regulators are active, will they be intelligent
June Economic adulteration for a new era
May New FDA leadership signals a new day for the agency and industry
April Checking in on FDA enforcement stats
March Nanotech taken up by Swiss group
February EU’s REACH chemicals law has arrived
January FDA official analyzes current and future food safety efforts
2008
December What’s new and what might be in the food realm
November Hey, do eat that, you know where it’s been
October New law tries to wake up sleepy commission
September Possible PVC packaging ban is latest California trend
August How can they get away with that? (Well, maybe they can’t.)
July Small particles may present big regulatory issues
June Does new bill hold future of EDA?
May Many sources of advice on enhancing supplier reliability
April Medical device civil suits are preempted, but for how long, and are drugs next?
March Drug Pedigree Requirements Come and Go, And Likely Will Com Again
February Food contact chemistry guidance document gets adjustments
January Action plan, food protection plan now lead the pack
2007
December Healthy prognosis for healthcare packaging
December Cosmetics safety storm brewing, or hadn’t you heard?
November New food reporting requirement hidden in drug law
October Label symbols make nutrition choices simpler, but never simple
September Lessons from China are for your quality program
August Sometimes the best things in life, and law, are the intangibles
July EU’s new REACH law on chemicals reaches you
June Irradiation again, labeling this time
May Food-contact notifications threatened again
May Fresh produce rules, uhh, guidelines, aim to improve safety
May Top 10 FDA developments
April Proposed rules on gluten finish the thought on food allergens law
March And just like that, packaging for irradiation is broadened
February OTC drugs and dietary supplements get new reporting burden
January Coalition’s diversity as dramatic as its message
2006
December All signs are pointing to a fruitful 2007
December Checking up on healthcare packaging
December Crisis planning takes exercise
November Pharmaceutical Packaging Forum taking shape
November Water, water is everywhere, perhaps not what you think
October Protecting food from terrorists
September FDA enforcement stats tell a story, but what is it?
August No more delays for drug pedigree requirement
July Divining qualified health claims policy by reading the tea leaves
June It’s time for packaging professionals to do some lobbying
June FDA still has no confirmed, permanent commissioner
June Packaging plays a role in combating obesity?
May Will PFOA issue stick to packaging?
March The Food Contact Notification program must be saved
February Preparing for threats takes practice for governments, too
January Will the road get bumpy for counterfeiters? And for you?

2005

December Claims, not chemistry, often make for product problems
November Taking FDA’s temperature in multiple ways
October New coalition advocates sustainability in packaging
September Don’t wait for government to address bioterror
August Doctors want borders between drugs and supplements
July Recalls, and plans for them, are key crisis tools
June Food labels must now name allergens, even from packaging
May Ephedrine saga: News reports can be of little help
April Cosmetic safety challenged
March Packaging to play a bigger role in the FDA budget
February Dietary advice affects packaging
January Three recent Rs of packaging

2004

 

December Dietary supplements: take slowly
November FDA strives for more efficient drug regulation
October Heavy new activity in toxic metals in packaging
September Post-9/11, USDA is active too
August Who turns on the RFID faucet, and does it matter?
July FDA gives food detention
June FDA to plant new crop of food GMPs
May Acrylamide saga continues, but how will it end?
April FDA counterfeiting report points to RFID, other technologies
March ‘Low-carb’ inspires label rules
February What FDA’s planned ban on ephedra means
January How to make FDA drug regulation obsolete

2003

December A device guidance is a guidance device
November FDA strategies on drug counterfeits point to packaging
October Packaging, drug safety, terror and counterfeits
September Should labels reflect everything that’s on our minds?
August Tough as they wanna be?
July Unit-dose goes to court
June More FDA bioterror food rules also include packaging
May Codes can bar drug errors: FDA
April At long last, dietary supplement GMPs
March FDA proposes: Packaging companies register, give notice of imports
February Dramatic shift in food health claims
January Program targets cancer-causers

2002

December New pressures await new FDA commissioner
November Food front roundup: Acrylamide, organic rules and obesity lawsuit
October FDA wants more ‘current’ Good Manufacturing Practices
September Surprise! You have the right to free speech
August Patent holders get help
July New bioterror law boosts FDA’s power
June Standardized over-the-counter labels are not all-over-the-map
May Today’s joke might be tomorrow’s law
April Tampering threats inspire packaging innovations
March HACCP here, and growing in several directions
February Food security guidances add weapons to anti-terror arsenal
January Happy New Year for FDA

2001

December Counterfeiting of drugs is just one side of product security
November Food safety in a new America
October Labels and the public’s trust
September Some want more food ingredient information on labels
August Do we need a single federal agency for food safety?
July Food allergies trigger voluntary industry action
June Packaging as antidote to medication errors
May Product liability prospects
April When labels speak (freely), people listen
March New administration: what’s next?
February Biotech and organic rules related
January December brings drug labeling developments, prescription and OTC

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2000

December OSHA targets injuries with headache
November Irradiation a material issue
October Machinery guidance is designed to increase safety, decrease liability
September Courts sorting tough drug vs. supplement issues
August Food packaging developments on the label and in the material
July Meat and poultry scene a hotbed of legal changes
June Bioengineered foods: breeding controversy
May New case means product knock-offs harder to stop
April FDA enforcement data, and hints of new approach
March Early warning on extended producer policies
February Label this dietary supplement rule “controversial”
January Food contact substances get new approval program

1999

December Packaging law developments at the end of the you-know-what
October Measuring value: a crucial corporate chore
September More free speech for off-label uses
August Heat on modernization, irradiation
July Food packaging changes part of revolutionary trend
June Understanding – and avoiding – a swirl of liability
May Why packaging laws really matter
April OTC drug labeling rules will change packages
March Air can hurt you, too
February FDA’s enforcement scorecard
January Solid waste rushes in

1998

December Year-end legal topic-o-rama
November Solid waste: the once & future issue
October The tale of possible “endocrine disruptors” may just be beginning
September Drug compliance still a problem packaging can address
August Ranting about EDF’s “labeling”
July EAS keeps an eye on packages
June Green guides still blooming
May New climate for irradiation and packaging, too
April Preemption as a useful device
March Feds watching feds on behalf of small business
February A cautionary tale of law for “responsible” corporate officials
January Ninety-eight topics for ’98

1997

December FDA reform in time for the holidays
November Dietary supplement labeling rules a further step to the frontier
October Flow controls throw out packaging freedom
September Milk study draws attention to packaging
August FDA reform back on the barbecue
July U.S. environment quiet for packagers for now
June It’s springtime, and the GRAS is growing
May WARNING
April OTC drug labeling format proposals are helpful but inflexible
March Air pollution controls could get tougher for package printers
February Target adjustment in lawsuit reform: Over-litigation
January FDA at crossroads with Kessler departure

1996

December A year-end review of January ’96 predictions
November Minor environmental revisions: Music to packagers’ ears?
October “Packaging law” emerges from obscurity
September When N.Y. Times recycles old information, packaging wins
July Are food label changes healthy?
June Congress wants FDA reform: OK, now’s the time to make a decision
May Can you (anti) trust a packaging columnist?
April Beer label complaints brewing
March ISO 14000 to change business environment
February FDA to loosen grip on food claims
January FDA says it’s changed its ways, but some still not convinced

1995

December Just your standard issue
November The exchange of recyclables grows up
October Packages meet shrinkage challenge
September FDA carries packaging across threshold
August A peek into the possible future of OTC labeling
July Pack taxes in all shapes and sizes
June New shades of trademarking
May Mirth or dearth on Earth Day birthday?
April Good intentions that got lost in translation
March Of contracts, regulations, and the future
February Packaging borders on the international
January Packages now have alternate route to trucking qualification

1994

December Analyzing trade dress doctrine
November Environmental claims perils continue
October Machinery must earn EU’s stamp of approval
September Safety and packaging are in-laws
August Regulators playing whole new ballgame
July Plastics makers chasing arrows and cooperation
June Patent decision panics packagers
May The states of the environment
April Label clashes are heavyweight bouts
March It’s a small world after all
February FDA takes daily supplements of controversy
January Has the FDA really been revitalized?

1993

December FDA at threshold of new approval approach
November Beware of un-American foreign ideas
October USDA turns up heat on meat labeling
September Drug packaging spurs regulatory, industry action
August West Coasting through enviro-issues
July Supermarkets carry assortment of legal issues
June Revered and reviled, plastics continue environmental battle
May When does competition cross the line?
April ISO 9000: ISO What?
March A few observations on the first 30 days
February ’93 view of EC ’92 isn’t 20/20
January End of the beginning for food label changes

1992

December For packagers, what comes ‘afta’ NAFTA
November Environmental laws: Options won’t be very optional
October FTC guidelines promise greener – but ‘cleaner’ landscape
September When it comes to packaging laws: Predictions are precarious
August Legal update on drug packaging
June FDA issues guidelines on using recycled plastic for food packages
May Corrugated industry still edgy over ECT
April From Maine to California: It’s packagers’ day in court
March Bush tries new attack on regulatory monster
February EC ’92; where are you?
January Food label proposals weigh in on packagers

1991

December Drug verdict raises costly questions of labeling and law
November Life cycle assessment: Big picture or big headache? October Recycled, fine. But for packaging food, yikes!
September Environmental claims get federal attention
August Summer thoughts on recycling, reform, rearmament
July Tylenol trial-that-wasn’t still sends messages
June Accounting for package design costs: Which way to go?
May Not all consumers are created equal
April Quartet of quandaries: An update
March Are packages telling ‘little green lies’?
February More exalted status for FDA?
January Some uneven chinks in food labeling ‘uniformity’

1990

November To overlook this deadline could be hazardous
October Four developments to keep an eye on
September Packagers face ‘new’ kids on legal block
September Food labels caught in tug of war
August What it says, not what it does
July Food technology rules to target microbes, limit packaging
June Chasing arrows chase plastics recycling uniformity
May FDA enforcement diagnosis
April Look! Up in the sky! It’s legislative change!
March EC ’92 harmony could be atonal
February When the news isn’t good: Some advice
January No rest for the weary food packager

1989

November Food labels to get an overhaul
September Strong winds from the West
July Twin cities law: On solid ground or shaky landfill?
May Food irradiation: Legal but unloved
March EPA’s Agenda for Action means business
January Refrigerated foods: Handle with care
March The Food Contact Notification program must be saved

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The Long Reach of FDA Accusations

The Long Reach of FDA Accusations

By Eric F. Greenberg, Attorney-at-law

The Long Reach of FDA Accusations

For those of you who think that regulators only pick on the small companies, have I got a story for you. And this story is also eye-opening if you have wondered who the government is most likely to go after when a problem arises, in a world of complicated chains of commerce involving multiple actors making and moving and bringing packaged products to market.

The short version of the story is that the Food and Drug Administration took action against Amazon for products sold on its website. Yes, that Amazon, the one with the big website where you can buy essentially everything for handy delivery. And this wasn’t the first time FDA has warned Amazon about products available on its popular website.

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