Posts Tagged ‘FTC’« Older Entries
When: Wednesday, June 26 to Thursday, June 27, 2013
Where: Chicago-Mart Plaza (Riverview) Hotel, Chicago, IL
For more information, and to register: click here
Industry related article from Examiner.com, by Mary Schwager, posted on 05/07/13:
Williams-Sonoma fined for failure to report defects in Pottery Barn products
Williams-Sonoma: BUSTED! The retailer is dishing out nearly a million dollars to pay a civil penalty to the Feds for failing to report product safety defects it knew about. Companies are supposed to report any defects, product failures or people injured by defective merchandise to the US Consumer Product Safety Commission ASAP. Looks like the company didn’t follow that ASAP part.
The defective product is a hammock stand made by Pottery Barn, a company owned by Williams-Sonoma. Here’s a link to the original recall in case you have one in your backyard.
The CPSC put out a news release today saying:
Williams-Sonoma, Inc., of San Francisco, Calif., has agreed to pay a $987,500 civil penalty.
In addition to paying a monetary penalty, Williams-Sonoma has agreed to implement and maintain a compliance program designed to ensure compliance with the safety statutes and regulations enforced by the Commission. Williams-Sonoma has also agreed to maintain and enforce a system of internal controls and procedures designed to ensure that:
Information required to be disclosed by the firm to the Commission is recorded, processed, and reported, in accordance with applicable law;
All reporting made to the Commission is timely, truthful, complete, and accurate; and
Prompt disclosure is made to Williams-Sonoma’s management of any significant deficiencies or material weaknesses in the design or operation of such internal controls that are reasonably likely to adversely affect, in any material respect, the company’s ability to report to the Commission.
Williams-Sonoma further agreed to provide written documentation of such improvements, processes, and controls, upon request of CPSC staff; to cooperate fully and truthfully with CPSC staff; and to make available all information, materials, and personnel deemed necessary to staff to evaluate the company’s compliance with the terms of the agreement.
The settlement resolves CPSC staff’s charges that the firm knowingly failed to report to CPSC immediately, as required by federal law, a defect involving Pottery Barn wooden hammock stands. Williams-Sonoma imported the wooden hammock stands between March 2003 and July 2008, and distributed them exclusively through Pottery Barn and PBteen catalogs and websites, and Pottery Barn Outlet stores. The hammock stands were sold nationwide for approximately $300.
CPSC staff alleged that when used outdoors, the wood in the hammock stands can deteriorate over time and break. Because the deterioration was occurring inside the metal bracket and was hidden from view, there was sometimes no outward indication to consumers that the wood was rotting until a consumer sat in the hammock and the beams broke. This posed fall and laceration hazards to consumers.
Williams-Sonoma did not file its full report with CPSC until September 11, 2008. On October 1, 2008, Williams-Sonoma and CPSC announced the recall of 30,000 wooden hammock stands. By that time, Williams-Sonoma was aware of 45 incidents involving the hammocks, including 12 reports of injuries requiring medical attention for lacerations, neck and back pain, bruising, and one incident involving fractured ribs.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.
When: Wednesday, October 10 to Thursday, October 11, 2012
Where: New York Marriott Downtown, New York, NY, USA
Over 3000 patent professionals representing both branded and generic manufacturers have learned why ACI’s Maximizing Pharmaceutical Patent Life Cycles Conference is the original and best drug life cycle management conference in the U.S. This year’s iteration will without a doubt continue the event’s long tradition of excellence in educating top professionals on the details of this complex but vital aspect of effective patent portfolio management. Featuring government officials from the USPTO, FDA, and FTC, our faculty will share best practices for:
- Understanding how the patent cliff will impact innovation and R&D, and alter the industry dynamic between brand names and generics
- Preparing for how the recently issued FDA regulations on biosimilars and the further implementation of BPCIA will affect pharmaceutical patent life cycle management strategies
- Assessing how the combined evolution of prior art obvious and obvious-type double patenting are influencing the future of secondary patents
- Evaluating patent life cycle strategies relative to personalized medicine vis-à-vis section 101 patentability post-Prometheus
- Examining the impact of REMS studies on generic entry
- Deciphering the relationship between use code controversies and inducement and divided infringement actions relative to Orange Book listings post-Caraco
- Exploring forfeiture rulings post-Lipitor
- Navigating new safe harbor dilemmas for both general screening and research tool patents
ADDED LEARNING VALUE
We are also pleased to offer the in-depth and practical training and strategy sessions that will address the essential and emerging focus of pharmaceutical patent life cycle management:
- Working Group Session: Assessing the Impact of New PTO Procedures Under the AIA on Hatch-Waxman Strategies Relative to Patent Life Cycle Management will offer in-depth and pragmatic advice for navigating the PTO’s new post-grant review and inter partes review proceedings, and much more.
- PTA- PTE Boot Camp: Basic Training in the Essentials of Patent Term Adjustment and Patent Term Restoration for Patent Lawyers Serving the Biopharmaceutical Industry will offer critical instruction on the fundamentals and mechanics of PTA and PTE practice which help to ensure patent and profit longevity
With a track record of attracting top counsel and business development executives from both branded and generic drug manufacturers, this event is a prime networking opportunity. Past iterations of have sold out – visit the conference home page, learn more about our exciting faculty of in-house, private practice, and government experts, and reserve your spot today!
When: Wednesday, October 03 to Thursday, October 04, 2012
Where: Millennium Knickerbocker, Chicago, IL, USA
Over the past month, the FDA has been busy issuing reports, releasing guidance and taking regulatory action as per directives required under the Food Safety Modernization Act, including:
- The recent issuance of the 2012 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices
- Publication of an updated guidance for industry on the use of food categories in food facility registrations
- A pending proposal to amend the food additive regulations to no longer provide for the use of Bisphenol A
How is your company prepared to respond to the many new regulatory changes expected under FSMA?
An invaluable opportunity to network and benchmark with your in-house peers, while also gaining firsthand insights directly from the FDA, FSIS, USDA and FTC, ACI’s FDA & USDA Compliance Boot Camp will include several sessions specifically dedicated to addressing new food safety requirements under FSMA, including:
- IMPORTS – how to ensure the safety of your food supply and comply with expected reform under Title III
- INSPECTIONS – addressing new Government jurisdiction and authority – what your company can do now to prepare
- FOOD and ANIMAL FEED – inside the current debate surrounding the agricultural use of antibiotics in livestock
Also benefit in-depth sessions on:
- The Jurisdiction, Function, Organization and Operations of the FDA, USDA, FTC and Other Health Agencies
- The Core Components of a Compliant Package Label
- GRAS and the Premarket Review and Approval Process for Food Additives
- How to Meet Strict FDA and USDA Food Safety Regulations to Prevent Adulteration and Contamination
- What Can and Cannot Be Said When Crafting Marketing and Advertising Claims
- How to Prepare and What to do to Prevent Pitfalls during Government Inspections
Take part in the following Mock Scenarios:
- How to Bring a New Food Market to Product – Best Practices of Ensuring Your Product Complies with Regulatory Requirements Across all Fronts
- Recall Management – How to Effectively Oversee a Recall and Avoid Common Mistakes that Lead to Litigation
Learn how to connect the dots of food regulatory law while gaining a clearer
understanding of how the FDA, USDA and FTC work together to regulate the food industry.
Optimize your networking opportunities by joining us at the Interactive Working Group:
A – FDA, USDA and FTC Food Law Fundamentals
B – Food Counsel’s Guide to Navigating the Legal Landscape in California
An added benefit of attending this event, attendees will receive a printed binder of materials which will include references to and copies of all the key regulations governing food and beverage products as well as all speaker presentation materials. Attendees are free to keep this binder and refer to it as a reference guide that can be shared and utilized as an information resource once back in the office.
Expert Article by Theodore J. Kobus
Responding to breaches involving employee information can be challenging, primarily because the affected employees see other affected colleagues at the coffee station, in the lunch room, or even walking down the hallway. Unlike most breaches, the affected employees have more opportunity to talk about a breach event with others affected. Also, whether legitimate or not, employees have an unspoken expectation that their employer will protect their personal information. We see call center rates and credit monitoring uptake rates in the 30-40% range following a breach involving employees which is much higher than what we see when the affected people are not employees.
The Federal Trade Commission (FTC) announced on Tuesday, May 3rd that it had reached a settlement with two companies involving the breach of information of almost 65,000 customer employees. Both settlements focused on allegations of inadequate security practices being in place. The FTC looked at network security and password management policies in place. No fine was issued, however, the companies involved will be subject to third-party security audits for 20 years.
In these cases, the employers were not the cause of the breach, but rather vendors used by the employer were involved. Still, employees expect that the companies their employer does business with will protect their information as well. There have been 34 complaints filed by the FTC since 2001 arising out of inadequate protection of personal information.
There is a gold mine of personal information in Human Resource Departments and companies need to identity their vulnerabilities as they relates to data leakage.
- Where is sensitive information being stored?
- Who has access to the information?
- Does the company have IT logs that can track that access?
- Are policies and procedures in place to safeguard information?
- Does the organization have a training program in place to protect the sensitive information it maintains?
Many of these may seem like common sense questions, but these are exactly the types of questions the regulators will ask following a breach. Additionally, companies need to review their vendor contracts and make sure that the contracts reflect the current state of privacy and data security laws. Some of you will be shocked to find out what you have agreed to in those old and dusty contracts. At the end of the day, when we are dealing with employee breaches, it does not matter who caused the breach because the employer will still feel the fallout.
ACI: Advanced Legal Summit on Food & Beverage Marketing & Advertising
March 31-April 1 – Washington, DC
Don’t miss this rare opportunity to gain firsthand insights directly from the government regarding current enforcement initiatives and the standards being applied to evaluate food and beverage marketing and advertising claims -
Mary Engle, Associate Director, Division of Advertising Practices, Bureau of Consumer Protection, FTC
Richard Cleland, Assistant Director, Division of Advertising Practices, Bureau of Consumer Protection, FTC
Kial Young, Senior Attorney, Division of Advertising Practices, Bureau of Consumer Protection, FTC
Jennifer Thomas, Director, Division of Enforcement, Office of Compliance, CFSAN, FDA
Vincent de Jesus, Nutritionist, Office of Nutrition, Labeling & Dietary Supplements, CFSAN, FDA
Kathryn L. Farrara, Staff Attorney, National Advertising Division
Take note as the FDA and FTC provide insights into how they are approaching key issues in food and beverage advertising and marketing as they speak on the following sessions –
Compiling Effective Scientific and Medical Evidence to Support Your Claim Substantiation
FDA & FTC Enforcement Priorities in Food Labeling and Advertising
Preparing for and Responding to Renewed Government Interest in Food Marketing to Children
Ensuring Compliant Front-of-Package Labeling
Knowing What Can and Cannot Be Said When Making Specific Food Product Claims
Understanding Current FTC Guidance on Endorsements and Testimonials
Specifically structured to focus in on the unique marketing and advertising challenges of the food and beverage industry, this conference will also provide you with the opportunity to benchmark with your colleagues at Yum! Brands, J.M. Smucker, Del Monte, Nestlé, Scripps Networks, General Mills, Herbalife and Coca-Cola as you learn what your company should be doing now to re-adjust its marketing and advertising practices in response to this new wave of FDA and FTC enforcement.
Full information on the summit can be found at www.AmericanConference.com/foodmarketing.
Excerpt from Pharmalive.com
NEWTOWN, Dec. 3, 2010–With an abundance of pharma products going off patent during the next several years, M&As – like that between Pfizer and Wyeth – and joint ventures have become increasingly more common as companies seek to replace revenue loss associated with the impending patent cliff for their blockbuster products. Another primary strategy being employed is extending patent life through new dose ranges, unique methods of administration, and/or gaining approvals for new indications.
Patent-infringement litigation against generic drug manufacturers remains commonplace as branded drug manufacturers struggle to prevent rapid and severe loss of revenue associated with generic entry. However, some of these lawsuits are more often being settled using reverse payments known as “pay-for-delay” deals in which the generic company will agree not to launch a generic drug for a certain period of time in exchange for financial compensation from the innovator company. The Federal Trade Commission reports that these types of settlements cost American consumers $3.5 billion per year as they miss out on generic drug pricing that can be as much as 90% less than brand prices. In early July 2010, the U.S. House of Representatives approved a ban on patent agreements between brand-name and generic drug companies.
Get the full article at PharmaLive
Learn more on ParagraphIV with American Conference Institute. Now in its fifth year, ACI’s Paragraph IV Disputes conference has become the most trusted source for the ‘ins and outs’ of Paragraph IV litigation. This first and original conference of its kind serves as the litigation playbook for brand name and generic drug companies in the high-stakes arena of Hatch-Waxman litigation. The inherent intensity of Paragraph IV litigation has been magnified of late by the seemingly unending repercussions of the Hatch-Waxman reforms of the MMA, pending Patent Reform legislation, the approval of an abbreviated pathway for follow-on biological products and the threat of proposed legislation, which may make settlements of these matters near impossible — let alone illegal. These factors have all added to the complexity of this litigation, and have also raised the monetary ante to unprecedented heights. In this environment, it is imperative that brand name and generic pharmaceutical companies and their counsel, have the offensive moves and defensive plays that they need to meet the challenges of pharmaceutical patent endgame litigation.
June 17th, 2008
in Advertising & Marketing |
June 17-18, 2008 • The Latham Hotel Georgetown • Washington DC
Industry insights straight from the enforcers
Top regulators and industry leaders tell you what they’re focusing on now and what they expect for optimum compliance:
Mary K. Engle
Division of Advertising Practices
Federal Trade Commission
Lesley A. Fair
Bureau of Consumer Protection
Federal Trade Commission
Andrea C. Levine
Director, National Advertising Division
Senior Vice President, CBBB
Peter C. Marinello
Director, Electronic Retailing
National Advertising Review Council
R. Glenn Yabuno
San Bernadino County District
Companies that advertise goods and services can find themselves subject to
government investigations and millions of dollars in fines and penalties for
violating federal and state regulations. This applies especially to companies that target children with their advertisements, make results claims about their products or are currently mounting green initiatives. Regulatory bodies such as the FTC, FCC, and state consumer enforcement divisions are turning a critical eye toward potential violations and violators.
The best means of avoiding these disastrous results is to know exactly which
advertising and marketing practices are on the government’s radar screens and how you are expected to comply with new and existing regulations…
The expansion of behavioral and viral marketing and inception of new social
networking sites, high-tech branding efforts, and interactive brand integration have created new areas of liability overnight. Additionally, wireless communications is an ever growing medium that falls under the purview of several federal regulatory agencies; however, understanding the FTC’s willingness, ability and current activity in this area of regulation is critical for anyone engaging in wireless advertising efforts.
Whether you have attended American Conference Institute’s Advertisers’ &
Marketers’ Regulatory Summit before or if this will be your first ACI
conference, you are sure to benefit from our updated, highly constructive and valuable panels. As always, this program is specially tailored to offer the very best of hands-on sessions and materials that you can apply directly to your practice. This year, we are introducing new faculty members from well-recognized positions within the regulatory agencies and industry critical self regulatory bodies as well as key advertisers and advertising companies, who are poised to bring you fresh perspectives on developments in:
• Judging the importance FTC’s recent settlements and key holdings
• Advanced procedures in building compliance systems
• Preventing unnecessary liabilities thought advanced claim substantiation
• Managing the complexities presented by national advertising campaigns
• Improving the quality and value of communications between your clients
and regulatory agencies
You can also add value to your attendance by taking advantage of our interactive workshop Unlocking the Complexities of the Doctrine of Substantiation. Register now to ensure your place at what is sure to be a sold-out event!
June 9th, 2008
in Advertising & Marketing |
June 9-10, 2008 | The Carlton | New York, NY
Gain industry insights into how to:
• Update or establish a compliance protocol for implementing
the requirements of the new GMP rule
• Revise your procedures for receiving, reporting, and maintaining
information on adverse events
• Market your product in a manner that will withstand regulatory
scrutiny while also protecting your brand and trademarks
• Utilize clinical research and scientific evidence to substantiate
• Insulate your company from liability when manufacturing, importing,
and selling products in international markets
Dietary supplement and food regulation has exploded over the last year.
In response to public and Congressional outcries for an active regulatory scheme to address the overall safety of dietary supplements and functional foods, the FDA responded in 2007 with the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Since the passage of the Act, the government has issued several guidances to industry over the past year clarifying the newly-imposed requirements for GMPs and adverse event reporting.
Revisit compliance programs in light of new regulatory requirements
Outlining progressive deadlines for companies of various sizes, the final GMP rule requires companies to completely re-evaluate their manufacturing practices for safety and efficiency. Additionally, as companies begin to grasp the effect of the new adverse event reporting and recordkeeping requirements, dietary supplement manufacturers, packers, distributors, and retailers must completely re-assess their business practices to ensure
procedures are in place at all levels for properly handling and reporting adverse events.
Brace for FDA and FTC monitoring of labeling and marketing practices
Faced with enforcement not only from the FDA, but also from the FTC, companies should also be revisiting product labeling and marketing procedures to ensure proper substantiation is provided for the use of particular health claims on dietary supplement, functional food and nutraceutical products. The FTC has earmarked the dietary supplement industry as an area of concern for the agency. As such, companies should
be re-evaluating their current practices and procedures to avoid a product being taken off the market.
Learn from your peers and benchmark your strategies against industry standards
Understanding what the concerns are of each agency and how your company can establish a viable compliance program are paramount to keeping your product on the market and out of the regulatory crosshairs. Before you finalize your compliance protocol, join us at the American Conference Institute’s 2nd Annual In-House Counsel Forum on Manufacturing, Marketing and Distributing Dietary Supplements, Nutraceuticals and Functional Foods Conference as our expert faculty provides you with
the most up-to-date and efficient strategies for meeting the needs of the current regulatory environment in your industry.
Take advantage of this unique opportunity to hear directly from the FTC
and the National Advertising Division on these issues, while also learning
from your peers. Register now to join us as at this timely event as we
provide you with solutions to the most pressing regulatory and legal
concerns of companies involved with the manufacture, distribution,
packing, or labeling of dietary supplements, nutraceuticals or functional
foods. Also, add value to your attendance by joining us at the
post-conference Master Class on Best Practices for Proving
Substantiation of Claims in Product Marketing, Advertising and