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Food, Dietary Supplement & Cosmetics Regulatory Update | Vol. III, Issue 14
The FDA answered a series of questions concerning the compliance dates for various nutrition initiatives, such as the Nutrition Facts Label final rule and the vending machine labeling rule.
United States
2 Nov 2016
Ninth Circuit Reverses Summary Judgment Regarding Dole's "All-Natural Fruit" Labeling But Affirms Decertification Of The Damages Class
On September 12, 2016, in an unpublished disposition, the Ninth Circuit reversed in part a district court's ruling that "All Natural Fruit" labeling on Dole Food Co. products was unlikely to deceive consumers.
United States
7 Oct 2016
AMS Establishes Marketing Agreement And Order For Pecans Grown In Certain States
The order provides authority to collect industry data and to conduct research and promotion activities.
United States
17 Aug 2016
First Financial Penalty Decision By The French ANSM
On May 19, 2016, the French National Drug and Health Product Authority ("ANSM") posted on its website its first two financial penalty decisions, adopted on May 12, 2016.
22 Jul 2016
FDA Issues CPG On Labeling And Marketing Of Certain Dog And Cat Foods
As discussed above, in the May 2, 2016, Federal Register, FDA announced the availability of Compliance Policy Guide ("CPG") Sec. 690.150...
United States
11 May 2016
FDA Announces Submission To OMB Of Information Collection On Quantitative Information In Direct-To-Consumer Television Advertisements
In the March 18, 2016, Federal Register, FDA announced that a proposed collection of information was submitted to the OMB, titled "Quantitative Information in Direct-to-Consumer Television Advertisements."
United States
13 Apr 2016
European Court Rules Against "Pro-Sugar" Advertising
The EC claimed the requested health claims conveyed a contradictory and ambiguous message to consumers, encouraging the consumption of sugar, which should instead be reduced.
European Union
6 Apr 2016
European Parliament Opposes Stripping Organic Certification From Products Contaminated With GMOs Or Pesticides
The EC's proposal applies even when products have been contaminated by GMOs or pesticides that have previously been authorized for use in foods within the EU.
European Union
14 Mar 2016
USDA Revokes "Grass Fed" And "Naturally Raised" Marketing Claims
Last month, USDA's Agricultural Marketing Service ("AMS") withdrew its standards for the marketing claims "grass fed" and "naturally raised,"...
United States
15 Feb 2016
California Supreme Court Says Organic Labeling Suit Is Not Preempted
On December 3, 2015, the California Supreme Court overturned an appellate court's ruling unanimously holding that a state law claim that produce is being intentionally mislabeled as "organic" is not preempted by federal law.
United States
22 Dec 2015
AMA Proposes Ban On Advertising Prescription Medical Products To Consumers
On November 17, 2015, physicians at the Interim Meeting of the American Medical Association ("AMA") adopted a new policy calling for a ban on DTC advertising of prescription drugs and medical devices.
United States
23 Nov 2015
OPDP Warning Letter Targets Social Media Campaign
FDA's Office of Prescription Drug Promotion ("OPDP") issued two warning letters regarding pharmaceutical product promotion in a two-week timeframe, most recently citing social media posts.
United States
18 Aug 2015
District Court Rules Against FDA In Off-Label Marketing Case
Last week, a federal judge in the Southern District of New York granted a preliminary injunction in favor of Amarin Pharma, Inc. ("Amarin") in its dispute against FDA asserting free speech rights to promote an approved drug for unapproved uses based on truthful and nonmisleading communications
United States
17 Aug 2015
Eleventh Circuit Reaffirms Rejection Of "Piggybacking" In Class Actions
A recent Eleventh Circuit decision that rejected a putative class representative's attempt to "piggyback" onto a previous class action may provide a defense to companies faced with seriatim class actions.
United States
11 Aug 2015
ECJ Issues Judgment On Labeling And Presentation Of Foodstuffs
On June 4, 2015, the European Court of Justice ("ECJ") published a decision on the interpretation of Directive 2000/13/CEE on labeling, presentation, and advertising of foodstuffs.
European Union
18 Jun 2015
Ireland Publishes New Guidance For Use Of Food Marketing Terms
The guidance will assist in the responsible use of marketing terms by food manufacturers, retailers, and food service businesses when placing their products on the market to ensure they convey clear, nonmisleading meanings.
9 Jun 2015
FDA Issued The Following Draft And Final Guidance Documents
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs, February 9, 2015, Federal Register.
United States
20 Feb 2015
FDA Announces Withdrawal Of Guidance, Replaced By Final Rules On Menu And Vending Machine Labeling
The withdrawn guidance has been superseded by FDA's issuance of final rules on menu and vending machine labelling.
United States
20 Feb 2015
FDA Proposes Rules For 505(b)(2) Applications And ANDAs
According to FDA, it has been implementing the MMA directly from the statute for several years and now seeks to amend its regulations to codify current practice and policy.
United States
17 Feb 2015
FDA Revises Draft Guidance On Drug Promotional Materials
FDA recently released updated draft guidance on how to explain risks to consumers in advertisements and labeling for prescription drugs, particularly the "consumer brief summary."
United States
16 Feb 2015
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