FTC Announces Regulatory Reform Measures Ranging from TVs and Textiles to Energy Labels and Email - Federal Trade Commission
As part of Federal Trade Commission Acting Chairman Maureen K. Ohlhausen’s regulatory reform initiative, the FTC is taking steps to ensure that its rules and guides keep pace with technological advances in the marketplace while continuing the agency’s mission to protect consumers and promote competition without unduly burdening legitimate business.
“Regulations can be important tools in protecting consumers, but when they are outdated, excessive, or unnecessary, they can create significant burdens on the U.S. economy, with little benefit,” said Acting Chairman Ohlhausen. “Private firms face constant market pressure to innovate and improve, and I see no reason why government should operate any differently. American taxpayers should expect nothing less from us,” Ohlhausen further stated.
Today’s announcement addresses the FTC’s Picture Tube Rule, Textile Rules, Energy Labeling Rule, and the CAN-SPAM Rule. Further streamlining may be in store as the FTC continues to conduct its regular, systematic reviews of all of its rules and guides, assessing the continuing need for them, as well as their costs and benefits, both to consumers and businesses.
Picture Tube Rule. The FTC is seeking public comment on the Picture Tube Rule, which requires manufacturers to adopt uniform measurement of television screen sizes to help consumers compare products. Specifically, the agency will be reviewing whether the rule is still needed, as well as the efficiency, costs, benefits and impact of the rule.
Initiated in 1966 and last amended in 1994, the Picture Tube Rule requires advertisers to base any representation of the screen size on the horizontal dimension of the actual, viewable area, unless they disclose the alternative method of measurement clearly and conspicuously.
Among the issues the FTC will consider are changes in television technology including, the incorporation of plasma, LED, OLED, and other similar materials in flat display screens.
The Advance Notice of Proposed Rulemaking on the Picture Tube Rule is available on the FTC's website and as a link to this press release and will be published in the Federal Register soon. Instructions for filing comments appear in the Federal Register Notice. Comments must be received by August 31, 2017; they will be posted at www.ftc.gov/policy/public-comments. (FTC File No. P174200; the staff contact is John Andrew Singer, Bureau of Consumer Protection, 202-326-3234)
Textile Rules. The FTC also is seeking public comment on a proposal to eliminate obsolete provisions of its Textile Labeling Rules, which require marketers to attach a label to a textile product disclosing the manufacturer or marketer name, the country where the product was processed or manufactured, and the generic names and percentages by weight of the fibers in the product.
The Textile Rule allows marketers to disclose a trademark used as a “housemark” (a distinctive mark used to identify all a firm’s products) on the tag in lieu of their business name, but only if they first register their housemark with the Commission. That provision, imposed in 1959, is no longer necessary because trademark owners can easily be identified by searching online or via the U.S. Patent and Trademark Office website.
The Notice of Proposed Rulemaking on the Textile Rules is available on the FTC's website and as a link to this press release and will be published in the Federal Register soon. Instructions for filing comments appear in the Federal Register Notice. Comments must be received by July 31, 2017; they will be posted at www.ftc.gov/policy/public-comments. (FTC File No. P948404; the staff contact is Laura Koss, Bureau of Consumer Protection, 202-326-2890)
Energy Labeling Rule. In addition, the FTC is updating its Energy Labeling Rule to eliminate provisions that are obsolete and unnecessarily burdensome and to account for new products in the marketplace.
The Energy Labeling Rule helps consumers consider the energy cost of consumer products by requiring yellow EnergyGuide labels on certain appliances to help consumers compare similar models. Among other things, the labels provide consumers with an estimated annual operating cost and an energy consumption rating.
In September 2016, the FTC sought public comment on proposed changes to the Rule. The changes eliminate obsolete marking requirements for plumbing products, exempt certain ceiling fans from labeling requirements, and update the labels to cover electric instantaneous water heaters. (FTC File No. R611004; the staff contact for final amendments to the Energy Labeling Rule is Hampton Newsome, Bureau of Consumer Protection, 202-326-2889.)
CAN-SPAM Rule. As part of its systematic review of its rules, the FTC also is seeking public comment on its rule implementing the CAN-SPAM Act, a 2003 law that sets requirements for commercial email and gives recipients the right to stop unwanted email.
The CAN-SPAM (Controlling the Assault of Non-Solicited Pornography and Marketing Act) Rule requires that a commercial e-mail contain accurate header and subject lines, identify itself as an ad, include a valid physical address, and offer recipients a way to opt out of future messages.
The FTC is seeking comment on whether consumers have benefitted from the Rule, whether it should be modified, the costs of compliance, whether it should be amended to account for technological or economic changes, among other things.
The Federal Register notice regarding the CAN-SPAM Rule is available on the FTC's website and as a link to this press release and will be published in the Federal Register soon. Instructions for filing comments appear in the Federal Register Notice. Comments must be received by August 31, 2017; they will be posted at www.ftc.gov/policy/public-comments. (FTC File No. R711010; the staff contact is Christopher E. Brown, Bureau of Consumer Protection, 202-326-2825)
The Commission vote approving each of these actions was 2-0.
Steel Concrete Reinforcing Bar from Japan and Turkey Injures U.S. Industry, Says USITC - U.S. International Trade Commission
The United States International Trade Commission (USITC) today determined that a U.S. industry is materially injured by reason of imports of steel concrete reinforcing bar from Japan and Turkey that the U.S. Department of Commerce (Commerce) has determined are sold in the United States at less than fair value and subsidized by the government of Turkey.
Chairman Rhonda K. Schmidtlein, Vice Chairman David S. Johanson, and Commissioners Irving A. Williamson, Meredith M. Broadbent, and F. Scott Kieff voted in the affirmative.
As a result of the USITC’s affirmative determinations, Commerce will issue antidumping duty orders on imports of this product from Japan and Turkey and a countervailing duty order on imports of this product from Turkey.
The Commission’s public report Steel Concrete Reinforcing Bar from Japan and Turkey (Investigation Nos. 701-TA-564 and 731-TA-1338 and 1340 (Final), USITC Publication 4705, June 2017) will contain the views of the Commission and information developed during the investigations.
The report will be available by July 21, 2017; when available, it may be accessed on the USITC website at: http://pubapps.usitc.gov/applications/publogs/qry_publication_loglist.asp.
USITC Makes Determination in Five-Year (Sunset) Review Concerning Gray Portland Cement and Cement Clinker from Japan U.S. International Trade Commission
The U.S. International Trade Commission (USITC) today determined that revoking the existing antidumping duty order on imports of gray portland cement and cement clinker from Japan would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
As a result of the Commission’s affirmative determination, the existing antidumping duty order on imports of this product from Japan will remain in place.
Chairman Rhonda K. Schmidtlein, Vice Chairman David S. Johanson, and Commissioners Irving A. Williamson, Meredith M. Broadbent, and F. Scott Kieff voted in the affirmative.
Today’s action comes under the five-year (sunset) review process required by the Uruguay Round Agreements Act. See the attached page for background on this five-year (sunset) review.
The Commission’s public report Gray Portland Cement and Cement Clinker from Japan (Inv. No. 731-TA-461 (Fourth Review), USITC Publication 4704, June 2017) will contain the views of the Commission and information developed during the review.
The report will be available by July 20, 2017; when available, it may be accessed on the USITC website at: http://pubapps.usitc.gov/applications/publogs/qry_publication_loglist.asp.
ITA: Press Releases - International Trade Administration
06/19/2017 U.S. Department of Commerce Issues Affirmative Preliminary Antidumping Duty Determinatiogn on Hardwood Plywood Products From China
06/19/2017 Preliminary Determination in the Antidumping Duty (AD) Investigation of Imports of Hardwood Plywood Products from the People's Republic of China (China)
06/20/2017 Final Determination of the Antidumping Duty (AD) Investigation of Imports of Dioctyl Terephthalate (DOTP) from Korea
U.S. Marshals Seize Adulterated Food from Minnesota Warehouse - Food & Drug Administration
FDA acts to prevent food distribution from an insanitary and filthy facility
The U.S. Food and Drug Administration announced that on June 15, the U.S. Marshals Service seized food products held at Professional Warehouse and Distribution, Inc., in St. Paul, Minnesota. The food products seized are worth approximately $73,000 and include, among other things, barley flour, spices, pasta, dried beans, tea and cookies.
The U.S. Department of Justice filed the complaint on behalf of the FDA in the U.S. District Court for the District of Minnesota alleging that the seized products are adulterated under the Federal Food, Drug, and Cosmetic Act.
“The FDA plays a key role protecting public health and ensuring not only that food is properly manufactured and labeled, but that it is handled and stored correctly as well,” FDA’s Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said. “The storage conditions in the warehouse were simply unacceptable, and the FDA took action to protect Americans.”
The FDA twice inspected the facility in 2015. In February 2015, the FDA found insanitary conditions that could cause the food product stored there to become adulterated. The company was inspected again in October 2015. The company had not implemented the corrective actions that it had promised following the earlier inspection, and the FDA identified additional adverse conditions at the warehouse. The company again promised to address these issues, but the FDA found additional problems during the latest inspection in 2017.
On May 26, 2017, the FDA administratively detained the food products held at the facility after witnessing widespread vermin activity during its most recent inspection, which was affecting the stored food. Under its administrative detention authority, the FDA can detain a food or dietary supplement product if the agency has reason to believe the product is adulterated or misbranded. The agency can keep detained products out of the marketplace for 20 days while it determines whether to take further enforcement action, such as seizure.
The products that the FDA administratively detained were then seized by the U.S. Marshals or embargoed by the state of Minnesota. To date, no illnesses have been associated with the food products held at Professional Warehouse and Distribution, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products
FDA Working to Lift Barriers to Generic Drug Competition - Food & Drug Administration
Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines.
Over the last decade alone, competition from safe and effective generic drugs has saved the health care system about $1.67 trillion. When generics are dispensed at the pharmacy, the immediate savings to each of us are clear. We could see even greater cost savings if we helped more safe and effective generic drugs get to market sooner, after patent and statutory exclusivity periods have lapsed, by addressing some of the scientific and regulatory obstacles to generic competition across the full range of FDA-approved drugs. These barriers may delay and, in some cases, ultimately deny patient access to more affordable drugs.
That’s why we’re working on a Drug Competition Action Plan. As part of this effort, today, we’re announcing in the Federal Register our intent to hold a public meeting on July 18, 2017, to solicit input on places where FDA’s rules – including the standards and procedures related to generic drug approvals – are being used in ways that may create obstacles to generic access, instead of ensuring the vigorous competition Congress intended.
Innovation in pharmaceutical development is essential because it creates new and sometimes life-saving therapies. But access to lower-cost alternatives, once patent and exclusivity periods lapse, also is critical to the nation’s health.
We know that sometimes our regulatory rules might be “gamed” in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition. We are actively looking at ways our rules are being used and, in some cases, misused.
One example of such gaming is the increasing unavailability of certain branded products for comparative testing. To perform the studies required to develop a generic alternative to a branded drug, a generic sponsor generally needs 1,500 to 3,000 doses of the originator drug. I understand that generic sponsors are willing to buy these products at fair market value; but, in some cases, branded companies may be using regulatory strategies or commercial techniques to deliberately try to block a generic company from getting access to testing samples.
This might occur, for example, when branded companies might use restrictions they place in their commercial contracts or their agreements with distributors to make it hard for intermediaries in the drug supply chain to sell the drugs to generic drug developers.
We also see problems accessing testing samples when branded products are subject to limited distribution – whether the company has voluntarily adopted limitations on distribution, or the limitations have been imposed as part of a Risk Evaluation and Mitigation Strategy, or REMS, a program that FDA implements to help ensure the safe use of certain drugs. I have been made aware that, in some of those cases, branded sponsors may use these limited distribution arrangements, whether or not they are REMS-related, as a basis for blocking generic firms from accessing the testing samples they need.
Besides limiting access to testing samples, some branded companies may be using the statutory default requirement to have a single shared REMS across both the branded and generic versions of a drug as a way to block generic entry. They might prolong negotiations with the generic firms over the implementation of these single shared systems, which could delay the entry of safe and effective generic drugs onto the market.
I want to take steps to address these concerns, to make sure that we are facilitating appropriate competition in circumstances where Congress intended. The forthcoming public meeting is intended to solicit public comment to inform us of circumstances where generic competition may be thwarted by these and other techniques.
As we solicit additional information, we also are going to be looking at policy and programmatic changes to address these issues. Some of these steps may be actions we can take by using our own authorities more forcefully. Other steps might involve our need to collaborate with sister agencies.
We’re also going to be looking hard at how best to coordinate with the Federal Trade Commission in identifying and publicizing practices that the FTC finds to be anti-competitive. FDA is not the FTC. It is the FTC’s responsibility to prevent anticompetitive business practices. But Congress set out certain laws that are meant to strike a careful balance between pharmaceutical innovation and access to lower cost generic products, and FDA has an important responsibility to enforce those laws in a manner that adheres to the balance struck by Congress.
We’ll be unveiling additional aspects of our larger Action Plan and providing updates, as these initial elements are implemented. I’m confident that these actions and the dedicated work of the outstanding staff in our generic drug program will help to address the issues patients are facing today when they’re priced out of buying the drugs they need. At the meeting on July 18 we want to hear from the public about ways our current rules may not be having their intended effects, and where current policies are falling short in ensuring the careful balance between new innovation and patient access.
Our goal is to broaden access to safe and effective generic drugs that can improve access to medicines and help consumers lower their health care costs. As in all of the things we do, we will steadfastly maintain FDA’s gold standard for rigorous, science-based regulation.
Over the past five years our generic drug program staff has evolved and grown remarkably, while implementing the first generic drug user fee program. The staff has demonstrated that they can rise to new challenges and they have my full support. Their hard work will serve as a strong foundation for the program as it moves forward. I want the policy framework they operate under to be as efficient, fair, and robust as the review program that they’re operating.