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Gottlieb speaks. Healthy, Qualified Claims, Allergies and overall Nutrition in Focus
As reported in several places, after what some consider two-years of radio silence, Scott Gottlieb, FDA Commissioner, addressed...
Debra Topham
Apr 2, 20182 min read


Kombucha lawsuits highlight risk for new products
The recent FoodNavigator article “Health-Ade lawsuit highlights continuing area of legal vulnerability for kombucha makers: sugar and...
Debra Topham
Mar 20, 20181 min read
New FDA Guidance – March 1, 2018
FDA has posted new guidance to help the US food and supplement businesses with compliance to the updated nutrition label regulations. ...
Debra Topham
Mar 1, 20181 min read


Warning Letter Lessons for Dietary Supplements
The FDA recently issued a warning letter to a dietary supplement company; KnowledgeBank has always recommended food and supplement...
Debra Topham
Feb 20, 20183 min read


FDA Guidance and Opioid Cessation Unapproved Drugs
This week Hyman, Phelps, McNamara PC, in their FDA Law Blog, summarizes two recent FDA events, and provides some insights into their...
Debra Topham
Feb 1, 20182 min read


FDA Posts “DRAFT” guidance on product recalls
January 17th the FDA, posted draft guidance for Recalls: “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C...
Debra Topham
Jan 23, 20183 min read


Planned Food Regulations for 2018
The Federal Government, publishes their Regulatory Agenda’s semi-annually. This Fall’s 2017 agenda has been published January 12, 2018...
Debra Topham
Jan 20, 20181 min read


National Organics Standards Board – Substance Update January 2018
National Organic Standards Board (NOSB) is proposing to: change the use restrictions for seventeen substances allowed for organic...
Debra Topham
Jan 18, 20181 min read


FDA Extends comment period for Soy Protein and Coronary Heart Disease Health Claims
Background “In the Federal Register of October 31, 2017, FDA published a proposed rule to revoke our regulation authorizing the use of...
Debra Topham
Jan 16, 20181 min read


New FDA Data Dashboard
The FDA gave us a New Year’s present – with a new Data Dashboard. They have created a contemporary — wow! yes contemporary! — and...
Debra Topham
Jan 7, 20181 min read


Bioengineered Food Disclosure and Labeling – On Track for July this Year!
The GMO law is still on schedule!!!! On July 29, 2016, congress mandated that USDA Agricultural Marketing Service (AMS) had until July...
Debra Topham
Jan 7, 20181 min read


Oregon Bottle Bill – Expands January 1st 2018
The Oregon Liquor Control Commission wants to remind consumers and retailers that additional beverages are being included in Oregon’s...
Debra Topham
Dec 17, 20171 min read


Is Restaurant Labeling like a Diet Plan that Never Starts?
The FDA recently released its Draft Guidance for Industry: Menu Labeling Supplemental Guidance, which proudly and prominently sstates...
Debra Topham
Nov 12, 20171 min read


“Local” — “Naturally” the next big fight?
Kelley Drye & Warren LLP, “Ad Law Access” bring us an article “Local” Means Something, but What? According to BakingBusiness, “A jury in...
Debra Topham
Nov 1, 20171 min read


Losing status “Soy” may no longer be heart healthy.
On Oct 31st, the FDA announced a new proposed ruling, to revoke 21 CFR 101.82 ” Health claims: Soy protein and risk of coronary heart...
Debra Topham
Nov 1, 20171 min read


FDA Releases Convenient Graphic for FSMA Deadlines
The Food and Drug Administration has posted a new webpage that consolidates information on FSMA (Food Safety Modernization Act.) Most...
Debra Topham
Oct 23, 20171 min read


Stay Alert to Wrigley’s relaunch of Caffeinated Alert Gum
Perhaps you have seen the news: Mars Wrigley brings back Alert Gum as FDA caffeine guidelines absent (FoodNavigator) Mars Wrigley seeks...
Debra Topham
Oct 23, 20171 min read


Is a “Healthy” food label claim now just puffery?
Keller and Heckman LLP in their blog, alerted us to a recent Wall Street Journal interview of FDA Commissioner, Dr. Scott Gottlieb. Both...
Debra Topham
Oct 23, 20172 min read


Gluten Free – Three Years after the new standards
The FDA just posted an interview “Taking a Look at the Real-World Impact of the Gluten-Free Labeling Standard” Background: Manufacturers...
Debra Topham
Oct 4, 20172 min read


Finish line moved, racing forward.
The New Nutrition Facts Final Rules Deadline Extended!!! Technically the FDA is “proposing to extend the Compliance Dates for the New...
Debra Topham
Oct 2, 20171 min read
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