FDA Law Blog - An Extra Dollop of Ketchup is Not a Crime! Or is it? Confusion Over Calories on Menus Continues

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• An Extra Dollop of Ketchup is Not a Crime! Or is it? Confusion Over Calories on Menus Continues
• What to Do When You Receive a DEA Order to Show Cause
• FDA Finalizes Guidance on When to Submit a 510(k) for a Change to an Existing Device
• FDA Denies Millennium Petition on Generic VELCADE and . . . Yada, Yada, Yada . . . Permits ANDA Labeling “Carve-in”/“Carve-up”
• FDA’s Digital Health Software Precertification (Precert) Program
• Just in time for Halloween, California Retailers Charged with Illegal Sale of Cosmetic Contact Lenses
• Nevada Scares Diabetes Drug Manufacturers With Halloween List of “Essential Diabetes Drugs”
• NOP Issues Interim Instruction Regarding Organic Imports
• NOP Issues Interim Instruction Regarding Organic Imports
• FTC Releases FY 2015 Staff Report on Drug Patent Settlement Agreements; Competitive DRUGS Act of 2017 Introduced in House

An Extra Dollop of Ketchup is Not a Crime! Or is it? Confusion Over Calories on Menus Continues Posted: 17 Nov 2017 04:07 AM PST Small business owners and managers of chain restaurants subject to FDA’s menu labeling rule remain confused as to the criminality of adding an extra dollop of ketchup to a hamburger. One thing is now clear — the only way to stop FDA’s years of wasteful dithering on menu labeling is for Congress to intervene. Last week, FDA issued another in a string of guidance documents, and again failed to explain or simplify the hopelessly complex regulations aimed at requiring the disclosure of calories on menus in chain restaurants. Continue reading An Extra Dollop of Ketchup is Not a Crime! Or is it? Confusion Over Calories on Menus Continues at FDA Law Blog.

What to Do When You Receive a DEA Order to Show Cause Posted: 16 Nov 2017 04:06 AM PST You may be a doctor, dentist, veterinarian, pharmacy, wholesale distributor, or manufacturer, and you just received an Order to Show Cause from the Drug Enforcement Administration (DEA). An Order to Show Cause can have a significant impact on your ability to handle controlled substances and, ultimately, to practice medicine or continue business operations. An Order to Show Cause must be taken seriously and requires a prompt response. This post summarizes DEA’s Order to Show Cause process, as well as highlights some important deadlines that you must meet to preserve your rights. Continue reading What to Do When You Receive a DEA Order to Show Cause at FDA Law Blog.

FDA Finalizes Guidance on When to Submit a 510(k) for a Change to an Existing Device Posted: 14 Nov 2017 04:05 AM PST On October 25, 2017, FDA issued a final guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device. This guidance is a final version of the draft issued in 2016 (see our post on the 2016 draft here). Despite receiving a significant number of comments, the final guidance is largely unchanged from the 2016 draft.  Industry should also be comforted to know that the final guidance is also, at its core, very similar to the 1997 guidance – a welcome relief as compared to the 2011 draft guidance. Continue reading FDA Finalizes Guidance on When to Submit a 510(k) for a Change to an Existing Device at FDA Law Blog.

FDA Denies Millennium Petition on Generic VELCADE and . . . Yada, Yada, Yada . . . Permits ANDA Labeling “Carve-in”/“Carve-up” Posted: 13 Nov 2017 04:03 AM PST Last week, FDA did something unprecedented (although not unexpected, at least by this blogger)! And based on the absence of any reporting in the trade press or online chatter, nobody seems to have taken note of FDA’s decision.  In a November 6, 2017 response to a June 9, 2017 Citizen Petition (Docket No. FDA-2017-P-3672) submitted by Millennium Pharmaceuticals, Inc. (“Millennium”) concerning the company’s drug product VELCADE (bortezomib) for Injection, 3.5 mg/vial (NDA 021602), FDA – apparently for the first time ever – ruled that the Agency will allow a generic drug manufacturer to “carve-up” brand-name labeling and “carve-in” to generic drug labeling a condition of use that no longer appears in brand-name labeling. Continue reading FDA Denies Millennium Petition on Generic VELCADE and . . . Yada, Yada, Yada . . . Permits ANDA Labeling “Carve-in”/“Carve-up” at FDA Law Blog.

FDA’s Digital Health Software Precertification (Precert) Program Posted: 12 Nov 2017 04:01 AM PST Digital health technologies are moving forward toward rapid adoption in the United States.  Yet, software developers are often apprehensive about the often long and detailed process of FDA’s premarket review.  FDA’s new Digital Health Software Precertification (Precert) Program (“Precert Program”), announced in August 2017 (see our previous post here), seeks to pilot a “fast-track” process for developers of software-as-a-medical device that the FDA trusts to produce consistently high quality, safe and secure products, removing the necessity to undergo the full-blown design and validation review for each new software product. Continue reading FDA’s Digital Health Software Precertification (Precert) Program at FDA Law Blog.

Just in time for Halloween, California Retailers Charged with Illegal Sale of Cosmetic Contact Lenses Posted: 09 Nov 2017 04:00 AM PST Back in the day, there were some freaky-looking cosmetic contact lenses that could make people look like they had the eyes of a wolf, a fish, or an insomniac vampire (excuse the redundancy, please). The costume accessories were especially popular with the frightener, if not the frightened. But, this Halloween, it was the FDA that was striking fear into the hearts of its targets. Four days before Halloween, the U.S. Attorney’s Office for the Central District of California filed misdemeanor criminal charges (here and here) against two retailers, TS Group, Inc. Continue reading Just in time for Halloween, California Retailers Charged with Illegal Sale of Cosmetic Contact Lenses at FDA Law Blog.

Nevada Scares Diabetes Drug Manufacturers With Halloween List of “Essential Diabetes Drugs” Posted: 08 Nov 2017 10:20 PM PST In June, we reported on Nevada S.B 539, a new law that, among other things, requires manufacturers of “essential diabetes drugs” to report certain sensitive financial information concerning these drugs. On October 31, the Nevada Department of Health and Human Services took the first step to implement this requirement by issuing its list of “essential diabetes drugs.” The list contains over 35 insulin products and other drugs, both brand and generic, determined by DHHS to be those most often prescribed for diabetes. Continue reading Nevada Scares Diabetes Drug Manufacturers With Halloween List of “Essential Diabetes Drugs” at FDA Law Blog.

NOP Issues Interim Instruction Regarding Organic Imports Posted: 07 Nov 2017 10:17 AM PST As we previously reported, the integrity of imported organic products has been questioned. International supply chains are becoming increasingly “complex” and frequently involve a number of businesses which may be certified under different programs. Foreign organic operations are subject to the same requirements as domestic organic operations, and only organic products verified to be in compliance with these regulations or arrangements can be imported for sale into the United States. Foreign operations may export their organic products into the United States under one of three scenarios: 1) They are certified organic by USDA-accredited certifiers under USDA organic regulations; 2) They are organic certified under a foreign standard that NOP has determined to be equivalent to the USDA organic standard; or 3) They are certified organic by foreign certifiers accredited by a foreign government to USDA standards. Continue reading NOP Issues Interim Instruction Regarding Organic Imports at FDA Law Blog.

NOP Issues Interim Instruction Regarding Organic Imports Posted: 07 Nov 2017 03:58 AM PST As we previously reported, the integrity of imported organic products has been questioned. International supply chains are becoming increasingly “complex” and frequently involve a number of businesses which may be certified under different programs. Foreign organic operations are subject to the same requirements as domestic organic operations, and only organic products verified to be in compliance with these regulations or arrangements can be imported for sale into the United States. Foreign operations may export their organic products into the United States under one of three scenarios: 1) They are certified organic by USDA-accredited certifiers under USDA organic regulations; 2) They are organic certified under a foreign standard that NOP has determined to be equivalent to the USDA organic standard; or 3) They are certified organic by foreign certifiers accredited by a foreign government to USDA standards. Continue reading NOP Issues Interim Instruction Regarding Organic Imports at FDA Law Blog.

FTC Releases FY 2015 Staff Report on Drug Patent Settlement Agreements; Competitive DRUGS Act of 2017 Introduced in House Posted: 06 Nov 2017 10:16 AM PST Last week, the Federal Trade Commission (“FTC”) announced the issuance of the Bureau of Competition’s annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2015) – Agreements Filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.  The FTC’s FY 2015 Staff Report is the second full fiscal year report issued since the U.S. Supreme Court’s June 17, 2013 decision in FTC v. Continue reading FTC Releases FY 2015 Staff Report on Drug Patent Settlement Agreements; Competitive DRUGS Act of 2017 Introduced in House at FDA Law Blog.