Administrative & Regulatory Archives - Page 61 of 95

Too Good To Be True: FTC’s Crackdown On L’Occitane’s Body Slimming Almond Extracts

L’Occitane Inc’s advertisements for its topically-applied body sculpting almond extracts seemed straightforward: “Almond Shaping Delight 3 out of 4 women saw firmer, lifted skin. This luxuriously lightweight massage gel instantly melts into the skin to help visibly refine and sculpt the silhouette” and “Almond Beautiful Shape Trim 1.3 inches in just 4 weeks. This ultra-fresh gel cream helps to visibly reduce the appearance of cellulite, while smoothing and firming the skin.”

Unfortunately for L’Occitane, an international skin care company with over 150 shops across the U.S., the Federal Trade Commission (FTC) found those claims dubious at best, and earlier this year charged the company with violating the Federal Trade Commission Act (“FTC Act”).

According to the FTC’s complaint, which was filed on January 7, 2014, L’Occitane had been manufacturing, advertising, and selling the two products at issue, “Almond Beautiful Shape” and “Almond Shaping Delight,” in interstate commerce and violated the FTC Act by promoting them as being able to slim and reshape the body. The FTC alleged that L’Occitane did not have sufficient scientific data to support L’Occitane’s advertising claims that the creams could trim the user’s thighs, reduce cellulite, and slim the body in just weeks. The FTC asserted that L’Occitane based its advertising claims in large part on two unblinded and non-controlled clinical trials and greatly exaggerated the results from one of the studies. The FTC charged L’Occitane with violating Sections 5(a) and 12 of the FTC Act, which declare unfair or deceptive acts or practices unlawful and bar false advertisements likely to induce the purchase of food, drugs, devices, or cosmetics. As part of the final consent order, the FTC fined L’Occitane $450,000 and prohibited it from making future false and deceptive weight-loss claims.

L’Occitane, however, is not the only entity which the FTC has recently fined because of questionable advertising claims. The FTC has also charged Sensa Products, LeanSpa, and HCG Diet Direct with violations of the FTC Act for allegedly misleading the public with unfounded weight loss claims and misleading endorsements relating to their products. These complaints, along with L’Occitane’s, were part of the FTC’s recent “Operation Failed Resolution” initiative, aimed at combating deceptive weight-loss claims.

One of the companies charged, Sensa Products, which claimed weight loss results from one of its dietary supplements, had to pay a $26 million fine for FTC Act violations. As a part of “Operation Failed Resolution,” the FTC also released an updated media guide for spotting deceptive weight-loss claims in advertising, entitled “Gut Check: A Reference Guide for Media on Spotting False Weight-Loss Claims.”

Manufactures and marketers of health products, cosmetics, drugs, and dietary supplements should be mindful of the FTC’s continuing and increasing vigilance in taking action with respect to enforcement of the FTC Act to stop unfounded weight loss claims. Companies making weight-loss claims in advertising and marketing materials must make sure that their claims are defensible and supported by sufficient credible scientific data.

Jordan Grushkin contributed to this article.

Article By:

Theodore C. Max

Of:

Sheppard, Mullin, Richter & Hampton LLP

IRS Introduces New Form 1023-EZ to Streamline Applications for 501(c)(3) Tax-Exempt Status

On July 1, 2014, the Internal Revenue Service (IRS) launched a new Form 1023-EZ, Streamlined Application for Recognition of Exemption Under Section 501(c)(3) of the Internal Revenue Code, that is intended to enable small charities to more easily apply for recognition of tax-exempt status under Internal Revenue Code Section 501(c)(3). The IRS has described the new form as a “common sense approach” to easing the filing burdens for small organizations and to shorten the time delays associated with IRS processing. Although not expressly stated, the new form is undoubtedly part of the IRS’s current effort to alleviate the huge backlog of pending applications awaiting IRS review.

What’s the general idea behind the new form?

The concept associated with the Form 1023-EZ is that the existing 26-page Form 1023 is simply unnecessary in the case of most small organizations. As designed, the new form becomes effectively a “registration” for exemption, rather than a comprehensive description of an organization’s activities, operations, governance, finances, etc. The IRS has clarified that the new forms will not undergo substantive review by IRS personnel. Rather, the IRS will defer that review until a later date when organizations are up and running; at that point, the IRS will evaluate whether organizations are functioning as described in their original filings.

When the new form was announced in draft form earlier this year, many industry experts voiced concern about foregoing the important educational and compliance opportunities associated with completing the full Form 1023 in its standard form. Others expressed doubt as to whether the IRS would be able to effectively and consistently perform the type of follow-up reviews asserted as the means for ensuring compliance with exemption standards. Nonetheless, the IRS has forged ahead, presumably under pressure to address its internal processing challenges and perhaps to present some much-needed “taxpayer-friendly” news from the Exempt Organizations Division.

Concurrent with issuing the new form, the IRS released Revenue Procedure 2014-40, which sets forth the procedures for using the new form and IRS’s processing of the same.

Who is eligible to use the new form?

The Revenue Procedure describes the scope of organizations that are eligible to use the form, consisting generally of organizations whose annual gross receipts have not exceeded $50,000 during any of the past three years and whose projected gross receipts for the current year and next two years are below that threshold. In addition, eligible organizations may not have total assets exceeding $250,000. Notably, when the draft Form 1023-EZ was initially announced earlier this year, the thresholds were appreciably higher – annual gross receipts of $200,000 or less and assets of $500,000 or less. In setting the final eligibility requirements, the IRS reduced those thresholds, presumably in response to exempt community (and possibly state charity official) voices expressing concern about this new approach being poorly suited to ferreting out actual or intended noncompliance, as discussed above.

The Revenue Procedure goes on to list other criteria that render an applicant ineligible to use the new form, including foreign organizations, successors to for-profit entities, churches, schools, colleges, universities, hospitals, supporting organizations described in IRC Section 509(a)(3), HMOs, ACOs, and entities maintaining donor-advised funds.

Notwithstanding the foregoing restrictions, the IRS has estimated that as many as 70 percent of organizations applying for 501(c)(3) status will be eligible to use the new form.

What does the new form look like?

Anyone who has tackled the process of preparing a Form 1023 in the past will recall the burden associated with wading through the standard 26-page application, which by necessity has traditionally covered a vast range of organizations (by size, scope and character) falling under the umbrella of 501(c)(3) status. By comparison, the new Form 1023-EZ is only three pages long and calls for:

Identifying information;
Form of entity under applicable state law, including check-box attestations regarding inclusion of appropriate language in pertinent organizational documents;
General information regarding the organization’s activities, using NTEE classification codes, check-box attestations regarding compliance with basic exemption requirements, and yes-or-no answers to high-level questions presumably aimed at fleshing out potentially at-risk conduct;
A check-box approach for attesting to public charity status; and
A check-box approach for organizations seeking reinstatement after losing their exemption due to failure to file annual information returns for three consecutive years.

A copy of the new form is available here. The accompanying instructions can be found here.

How is the new Form 1023-EZ to be filed?

Form 1023-EZ must be filed electronically, using the www.pay.gov website. A $400 user fee applies. Once filed, the IRS process will consist of determining whether an application is complete, meaning that the applicant has provided a response to each line item in the form. If a form is incomplete, the IRS may request additional information accordingly. Once complete, the IRS will accept the form for processing.

What if we have a pending Form 1023 already in the queue at the IRS?

If an organization has already submitted Form 1023 to the IRS, it may nevertheless submit Form 1023-EZ if its Form 1023 has not yet been assigned for review. In that case, the IRS will treat the Form 1023 as withdrawn and will instead process the organization’s Form 1023-EZ.

Corey Kestenberg contributed to this article.

Article By:

Linda S. Moroney

T.J. Sullivan

Taylor A. Romigh

Of:

Drinker Biddle & Reath LLP

Department of State Releases August 2014 Visa Bulletin

The bulletin shows minor advancement in the EB-2 category for applicants chargeable to India and China as well as significant advancement in the EB-3 category for applicants chargeable to China and the Philippines, minor advancement for applicants chargeable to India, and no change for applicants chargeable to Mexico or the Rest of the World.

The U.S. Department of State (DOS) has released its August 2014 Visa Bulletin. The Visa Bulletin sets out per country priority date cutoffs that regulate the flow of adjustment of status (AOS) and consular immigrant visa applications. Foreign nationals may file applications to adjust their statuses to that of permanent residents or to obtain approval of immigrant visas at a U.S. embassy or consulate abroad, provided that their priority dates are prior to the respective cutoff dates specified by the DOS.

What Does the August 2014 Visa Bulletin Say?

In August, the cutoff date for applicants in the EB-2 India category will advance by a little more than four months, while the cutoff date for applicants in the EB-2 China category will advance by a little more than three months. Meanwhile, the cutoff date in the EB-3 China category will advance by slightly more than two years, while the cutoff date in the EB-3 Philippines category will advance by 17 months. The EB-3 India category will advance by one week, while the cutoff date for EB-3 Mexico and the Rest of the World will remain unchanged. The cutoff date in the F2A category for applicants from all countries will also remain unchanged.

EB-1: All EB-1 categories will remain current.

EB-2: The cutoff date for applicants in the EB-2 category chargeable to India will advance by a little more than four months to January 22, 2009. The cutoff date for applicants in the EB-2 category chargeable to China will advance by slightly more than three months to October 8, 2009. The EB-2 category for all other countries will remain current.

EB-3: The cutoff date for applicants in the EB-3 category chargeable to India will advance by one week to November 8, 2003. The cutoff date for applicants in the EB-3 category chargeable to China will advance by a little more than two years to November 1, 2008. The cutoff date for applicants in the EB-3 category chargeable to the Philippines will advance by one year and five months to June 1, 2010. The cutoff date for applicants chargeable to Mexico and all other countries will remain unchanged at April 1, 2011.

The relevant priority date cutoffs for foreign nationals in the EB-3 category are as follows:

China: November 1, 2008 (forward movement of two years and one month)
India: November 8, 2003 (forward movement of one week)
Mexico: April 1, 2011 (no movement)
Philippines: June 1, 2010 (forward movement of one year and five months)
Rest of the World: April 1, 2011 (no movement)

Developments Affecting the EB-2 Employment-Based Category

Mexico, the Philippines, and the Rest of the World

The EB-2 category for applicants chargeable to all countries other than China and India has been current since November 2012. The August Visa Bulletin indicates no change, meaning that applicants in the EB-2 category chargeable to all countries other than China and India may continue to file AOS applications or have applications approved through August 2014.

China

The July Visa Bulletin indicated a cutoff date of July 1, 2009 for EB-2 applicants chargeable to China. The August Visa Bulletin indicates a cutoff date of October 8, 2009, reflecting forward movement of three months and one week. This means that applicants in the EB-2 category chargeable to China with a priority date prior to October 8, 2009 may file AOS applications or have applications approved in August 2014.

India

In December 2013, the cutoff date for EB-2 applicants chargeable to India retrogressed significantly to November 15, 2004 because of unprecedented demand in this category. This cutoff date remained constant through June. There was significant movement forward of nearly four years in the July Visa Bulletin. The August Visa Bulletin indicates a cutoff date of January 22, 2009, reflecting forward movement of another four months and three weeks. This means that applicants in the EB-2 category chargeable to India with a priority date prior to January 22, 2009 may file AOS applications or have applications approved in August 2014.

Developments Affecting the EB-3 Employment-Based Category

China

In late 2013 and early 2014, the cutoff date for EB-3 applicants chargeable to China advanced significantly to generate demand in this category. In June, to regulate demand, this cutoff date retrogressed by six years to October 1, 2006 and remained the same for July. The August Visa Bulletin indicates a cutoff date of November 1, 2008, reflecting forward movement of two years and one month. This means that only applicants in the EB-3 category chargeable to China with a priority date prior to November 1, 2008 may continue to file AOS applications or have applications approved in August 2014.

India

The July Visa Bulletin indicated a cutoff date of November 1, 2003 for EB-3 applicants chargeable to India. The August Visa Bulletin indicates a cutoff date of November 8, 2003, reflecting forward movement of one week. This means that only EB-3 applicants chargeable to India with a priority date prior to November 8, 2003 may file AOS applications or have applications approved in August 2014.

Rest of the World

From September 2013 through April 2014, the cutoff date for EB-3 applicants in the worldwide category advanced by 3.75 years. In June, to regulate high demand, the cutoff date in this category retrogressed by 549 days to April 1, 2011. The August Visa Bulletin indicates no change to this cutoff date. This means that only applicants in the EB-3 category chargeable to the Rest of the World with a priority date prior to April 1, 2011 may file AOS applications or have applications approved in August 2014.

Developments Affecting the F2A Family-Sponsored Category

In March, as a result of heavy demand in the F2A category from applicants chargeable to Mexico, the cutoff date in this category retrogressed significantly to April 15, 2012. In June, this cutoff date retrogressed again to March 15, 2011 and remained the same in July. The August Visa Bulletin indicates no change to this cutoff date. This means that only those applicants from Mexico with a priority date prior toMarch 15, 2011 will be able to file AOS applications or have applications approved in August 2014.

During fiscal year 2013, in an effort to generate demand in the F2A category from applicants from all countries other than Mexico, the cutoff date in this category advanced significantly. This advance resulted in a dramatic increase in demand, followed in June by a further retrogression of the cutoff date to May 1, 2012. The August Visa Bulletin indicates no change to this cutoff date. This means that only those F2A applicants from countries other than Mexico with a priority date prior to May 1, 2012will be able to file AOS applications or have applications approved in August 2014. Further retrogression of the worldwide F2A category should not be ruled out.

How This Affects You

Priority date cutoffs are assessed on a monthly basis by the DOS, based on anticipated demand. Cutoff dates can move forward or backward or remain static. Employers and employees should take the immigrant visa backlogs into account in their long-term planning and take measures to mitigate their effects. To see the August 2014 Visa Bulletin in its entirety, please visit the DOS website.

Article By:

Eric S. Bord

Lisa Stephanian Burton

Tracy Evlogidis

Malcolm K. Goeschl

Eleanor Pelta

A. James Vázquez-Azpiri

Of:

Morgan, Lewis & Bockius LLP

SEC Settles Civil Foreign Corrupt Practices Act (FCPA) Action Against Two Former Oil Services Executives

On the eve of a trial which was scheduled to begin this week, the Securities and Exchange Commission settled a civil Foreign Corrupt Practices Act (FCPA) case it brought against two former oil services executives. The case was an outgrowth of anindustry-wide investigation the SEC had initially commenced beginning in 2010.

In February 2012, the SEC filed a complaint against Mark A. Jackson, who was the former CEO and CFO of Noble Corporation, and James J. Ruehlen, former Director and Division Manager of Noble’s Nigerian subsidiary, alleging that they authorized the payment of bribes to customs officials to process false paperwork that purported to show the export and re-import of oil rigs, which was necessary under the requirements of Nigerian law. In fact, the rigs had never been moved. The SEC alleged that the scheme was part of a design to save Noble from losing business and incurring costs associated with exporting rigs from Nigeria and re-importing them under new permits. The complaint asserted violations of the anti-bribery and books and records provisions of the FCPA. The complaint also detailed the fact that Jackson had refused to cooperate during Noble’s internal investigation of the matter and had asserted his Fifth Amendment rights and refused to testify during the SEC investigation.

The settlement with Jackson and Ruehlen was the last in a lengthy saga of FCPA actions against Noble and its former employees. Noble was initially charged with FCPA violations in a civil action in 2010. The company settled, agreeing to pay more than $8 million in fees. The SEC filed charges against Jackson and Ruehlen in 2012 following the corporate settlement and also filed charges against Thomas F. O’Rourke, the former controller and head of internal audit at Noble. O’Rourke quickly settled and agreed to pay a penalty.

Despite pursuing the action for more than two years and alleging serious wrongdoing by the defendants, including responsibility for an extensive bribery scheme, the SEC agreed to settle with Jackson and Ruehlen just two days before their trial was to commence with an injunction against violating the books and records provision of the FCPA. Although Noble had settled its own case for a hefty penalty, neither Jackson nor Ruehlen were required to pay a fine, concede a violation of the bribery provisions of the FCPA nor agree to restrictions on employment.

SEC v. Jackson et al., No. 4:12-c-00563 (S.D. Tex. Jul. 7, 2014).

Article By:

Emily Stern

Ashley H. Jones

Of:

Katten Muchin Rosenman LLP

Proposed Legislation Introduced to Override Hobby Lobby Ruling

On July 9th, Senator Democrats introduced proposed legislation known at the Protect Women’s Health from Corporate Interference Act (Act) in an effort override the U.S. Supreme Court’s Hobby Lobby decision, which was previously discussed in our June 30th Alert.

The Act would reinstate the Affordable Care Act’s contraceptive coverage obligations imposed on employers, requiring employers to provide such health insurance. The Act specifically is targeted at the Supreme Court’s 5-4 Hobby Lobby decision, which held closely-held companies (those that are family-owned or have a limited number of shareholders) can exercise their freedom of religion protections to avoid paying for such contraceptive coverage. Senator Tom Harkin (D-Iowa), one of the three Senators who introduced this legislation, explained that houses of worship and religious non-profits would remain exempt from providing contraceptive coverage under the Act.

The introduction of this legislation in the Senate follows the announcement by two House Democrats last week, indicating they would introduce similar bills in response to the Hobby Lobby decision. If the legislation were to pass the Senate, many experts anticipate it will fail in the Republican-controlled House.

Article By:

Tina A. Syring

Of:

Barnes & Thornburg LLP

European Commission Discusses Big Data

The European Commission (the Commission) recently issued a press release recognizing the potential of data collection and exploitation (or “big data”) and urging governments to embrace the positive aspects of big data.

The Commission summarized four main problems that have been identified in public consultations on big data:

Lack of cross-border coordination
Insufficient infrastructure and funding opportunities
A shortage of data experts and related skills
A fragmented and overly complex legal environment

To address these issues, the Commission proposed the following:

A public-private partnership to fund big data initiatives
An open big data incubator program
New rules on data ownership and liability for data provision
Mapping of data standards
A series of educational programs to increase the number of skilled data workers
A network of data processing facilities in different member states

The Commission stated that, in order to help EU citizens and businesses more quickly reap the full potential of data, it will work with the European Parliament and the European Council to successfully complete the reform of the EU’s data protection rules. The Commission will also work toward the final adoption of the directive on network and information security to ensure the high level of trust that is fundamental for a thriving data-driven economy.

Article By:

Barbara Murphy Melby

Doneld G. Shelkey

Of:

Morgan, Lewis & Bockius LLP

What Does Regulation of Greenhouse Gas Emissions as Described by EPA in the “Tailoring Rule” have to do with the Clean Air Act?

UARG v. EPA: Tailoring Rule Litigation

On June 23, 2014 Justice Scalia delivered the opinion of the U.S. Supreme Court on the question of whether EPA motor vehicle greenhouse gas regulations necessarily automatically triggers permitting requirements under the CAA for stationary sources that emit greenhouse gases. The statements in the opinion concerning EPA’s assertions of power are quite provoking. If read carefully, this opinion launches a warning to EPA about its future regulatory actions relative to greenhouse gases. The text of the opinion can be found here. The following quotes are offered as examples of that warning.

“EPA’s interpretation is also unreasonable because it would bring about an enormous and transformative expansion in EPA’s regulatory authority without clear congressional authorization. When an agency claims to discover in a long-extant statute an unheralded power to regulate “a significant portion of the American economy,” Brown & Williamson, 529 U.S. at 159, we typically greet its announcement with a measure of skepticism. We expect Congress to speak clearly if it wishes to assign to an agency decisions of vast “economic and political significance.” Id., at 160; See Also MCI Telecommunications Corp. v. American Telephone & Telegraph Co., 512 U.S. 218, 231 (1994); Industrial Union Dept., APL-CIO v. American Petroleum Institute, 448 U.S. 607, 645-646 (1980) (plurality opinion). Slip op at 19.

“. . . in EPA’s assertion of that authority, we confront a singular situation: an agency laying claim to extravagant statutory power over the national economy while at the same time strenuously asserting that the authority claimed would render the statute “unrecognizable to the Congress that designed” it. “ Slip op at 20.

“We are not willing to stand on the dock and wave goodbye as EPA embarks on this multiyear voyage of discovery. We reaffirm the core administrative-law principle that an agency may not rewrite clear statutory terms to suit its own sense of how the statute should operate.” Slip op at 23.

In a step wise fashion the opinion presents and answers the following:

1. The question before the Court was “. . .whether it was permissible for EPA to determine that it motor-vehicle greenhouse-gas regulations automatically triggered permitting requirements under the Act for stationary sources that emit greenhouse gases.” Slip op at 2.

First we decide whether EPA permissibly interpreted the statute to provide that a source may be required to obtain a PSD or Title V permit on the sole basis of its potential greenhouse-gas emissions. Slip op at 10.

“It is plain as day that the Act does not envision an elaborate, burdensome permitting process for major emitters of steam, oxygen, or other harmless airborne substances. It takes some cheek for EPA to insist that it cannot possibly give “air pollutant” a reasonable, context-appropriate meaning in the PSD and Title V context when it has been doing precisely that for decades.” Slip op at 12.

“Massachusetts does not strip EPA of authority to exclude greenhouse gases from the class of regulable air pollutants under other parts of the Act where their inclusion would be inconsistent with the statutory scheme.” Slip op at 14.

“In sum, there is no insuperable textual barrier to EPA’s interpreting “any air pollutant” in the permitting triggers of PSD and Title V to encompass only pollutants emitted in quantities that enable them to be sensibly regulated at the statutory thresholds, and to exclude those atypical pollutants that, like greenhouse gases, are emitted in such vast quantities that their inclusion would radically transform those programs and render them unworkable as written.” Slip op at 16.

2. . . . we next consider the Agency’s alternative position that its interpretation was justified as an exercise of its “discretion” to adopt “a reasonable construction of the statute.” Tailoring Rule 31517. We conclude that EPA’s interpretation is not permissible.” Slip op at 16.

“EPA itself has repeatedly acknowledged that applying the PSD and Title V permitting requirements to greenhouse gases would be inconsistent with – in fact, would overthrow – the Act’s structure and design.” Slip op at 17.

“A brief review of the relevant statutory provisions leaves no doubt that the PSD program and Title V are designed to apply to, and cannot rationally be extended beyond, a relative handful of large sources capable of shouldering heavy substantive and procedural burdens.” Slip op at 18.

3. “We now consider whether EPA reasonably interpreted the Act to require those sources to comply with “best available control technology” emission standards for greenhouse gases.” Slip op at 25.

“EPA argues that carbon capture is reasonably comparable to more traditional, end-of-stack BACT technologies, . . . and petitioners do not dispute that.” Slip op at 26. “. . . it has long been held that BACT cannot be used to order a fundamental redesign of the facility.” “. . . EPA has long interpreted BACT as required only for pollutants that the source itself emits; accordingly, EPA acknowledges that BACT may not be used to require “reductions in a facility’s demand for energy from the electric grid.” Slip op at 27.

“The question before us is whether EPA’s decision to require BACT for greenhouse gases emitted by sources otherwise subject to PSD review is, as a general matter, a permissible interpretation of the statute under Chevron. We conclude that it is.” Slip op at 27.

“We acknowledge the potential for greenhouse-gas BACT to lead to an unreasonable and unanticipated degree of regulation, and our decision should not be taken as an endorsement of all aspects of EPA’s current approach, nor as free rein for any future regulatory application of BACT in this distinct context. Our narrow holding is that nothing in the statute categorically prohibits EPA from interpreting the BACT provision to apply to greenhouse gases emitted by “anyway” sources.” Slip op at 28.

Opinion of Breyer, with whom Ginsburg, Sotomayor and Kagan join, concurring in part and dissenting in part. Rather than exempting certain air pollutants like greenhouse gas emissions from the statute, it makes more sense to read into the statute an exemption for certain sources that were never intended to be subject to PSD.

Opinion of Alito, with whom Thomas joins, comments that Massachusetts v. EPA was wrongly decided at the time, and these cases further expose the flaw with that decision.

July 4th Puts the Federal Aviation Administration (FAA) Drone Policy to the Test

Dramatic videos posted over the holiday weekend show fireworks displays that were filmed from drones. The videos are remarkable, with the drones often flying within the sweep of the exploding shells. Burning fireworks frequently zoom past the cameras. We found drone fireworks videos from Decatur, Ga., Lake Martin, Ala., Oak Mountain State Park, Ala., and Nashville, Tenn. The drone operators may have been inspired by a popular YouTube video of fireworks over West Palm Beach that attracted more than 6 million views and considerable press coverage.

We expect that the videos are also causing post-holiday headaches at the FAA. The FAA’s reaction to these videos may prove to be an early test of its recent regulatory notice interpreting its longstanding rules on model aircraft.

As we previously reported, the FAA is playing catch up on its drone rules. For years, the agency’s regulation of drones was limited to an advisory circular from 1981 and a policy statement from 2007, neither of which provided a comprehensive set of rules. In March, the agency lost an enforcement action against a drone operator largely because it had never adopted specific regulations for drones.

On June 23, the FAA took a substantial step forward by issuing a notice of the agency’s interpretation of its authority to regulate drones. The notice interprets Congress’s 2012 FAA legislation, including a provision that prohibits FAA regulation of model aircraft that are flown for “hobby or recreational” purposes and that meet certain other criteria.

In a key provision of the interpretation, the FAA stated that Congress’s prohibition on regulating model aircraft does not prohibit the agency from enforcing – against drone operators – the “general rules . . . that apply to all aircraft.” This interpretation would permit the agency, for example, to allege that the fireworks drone operators violated regulations that prohibit careless and reckless operations that endanger life or property.

Finally, for those following the FAA’s position on commercial operation of drones, the fireworks videos may present a novel issue related to compensation. In the June 23 interpretation, the FAA reiterated its longstanding position that commercial drone operations are generally prohibited, and the agency cited the example of “photographing [an] event and selling the photos to someone else.”

Some of the fireworks videos we reviewed were preceded by advertisements, which would appear to indicate that they are part of the YouTube Partner Program, where a portion of the advertising revenue is paid to the video creator. The FAA has traditionally adopted a very broad view of commercial operations, and it will be interesting to see whether it considers “monetized” videos to cross the line.

We expect the FAA may have something to say about these fireworks videos.

Article By:

Brian D Smith

Of:

Covington & Burling LLP

FDA Issues Guidance for Safety of Nanomaterials in Cosmetic Products (as well as in Food)

For the last seven or so years, the U.S. federal government and some state governments have been collecting cradle-to-grave information regarding nanomaterials. The data collection call-ins were intended to create a collaborative, scientific dialogue with the goal of examining relevant information, and identifying information gaps and ways to address those gaps.

Last week, the FDA issued guidance documents for both cosmetic and food manufacturers. The guides are one more step intended to assist industry and other stakeholders in identifying the potential safety issues of nanomaterials in consumer products and in developing a framework for evaluating them. It also provides contact information for those who wish to discuss safety considerations regarding the use of specific nanomaterials in cosmetic products with the FDA.

If your company is considering the use of nanomaterials in its products, it is important to recognize that although nanotech cosmetics are still subject to the same legal requirements as other cosmetics, in that they do not require premarket approval, the products must be safe under customary usage conditions and properly labeled. Additionally, although the FDA has explained that the current safety framework used for conventional cosmetics is still appropriate for cosmetics using nanotech, companies should keep in mind the unique properties of nanomaterials when testing safety. Ultimately, as this guidance reminds, companies are legally liable for ensuring the safety of their products. As to food products, the FDA encourages manufacturers to contact the agency early in the development process to assist in assessing the safety and potential issues with using nanotechnology.

Read the complete press announcement from the FDA here.

Article By:

Angela Diesch

Of:

Greenberg Traurig, LLP

US Customs and Border Patrol (CBP) Announces Trusted Trader Program Test

U.S. Customs and Border Protection (“CBP”) announced today the commencement of its long-anticipated Trusted Trader Program test which will run for 18 months in collaboration with the U.S. Consumer Product Safety Commission (“CPSC”) and theU.S. Food and Drug Administration (“FDA”). In effect, the Trusted Trader Program will combine the current Customs-Trade Partnership Against Terrorism (“C-TPAT”) and Importer Self-Assessment (“ISA”) program with the objective of streamlining the process through which importers can establish that they strive to secure their supply chains and strengthen their internal controls for compliance with the laws and regulations administered or enforced by CBP, including those of other government agencies.

Currently, importing companies can participate in C-TPAT, which focuses on securing supply chains, and ISA, which focuses on strengthening internal controls to comply with Customs laws and regulations in exchange for special benefits. If a company wants to participate in ISA, that company must also be in C-TPAT. By combining the two programs, the Trusted Trader Program will move toward a whole-government approach to supply chain security and trade compliance thereby strengthening government collaboration among different government agencies – CBP, the FDA, and the CPSC. It will also align with the Authorized Economic Operator (“AEO”) programs around the world, which focus on a combined security and compliance model.

Benefits of Participation

To encourage participation in this dual model, CBP is offering the following additional benefits to those currently offered to C-TPAT and ISA members:

A reduced FDA targeting/examination risk score;
A penalty offset, upon request, as part of a CBP penalty mitigation decision;
For Reconciliation program participants, an ability to flag and unflag entries retroactively after the entry summary is filed up until 60 days prior to the date of liquidation;
A reduction in Foreign Trade Zone on-site inspections;
An exemption from on-site visits from Drawback Specialists, for drawback claimants;
A limit of one full desk review per year for drawback claimants;
An exemption from random Non-Intrusive Inspections (although the right is reserved to conduct the inspections as appropriate for operational reasons);
A quarterly submission of the CAS number, the use, and the description for the chemical compound in advance of the calendar year quarter;
A promise from CBP to process Post-Entry Amendments on unliquidated entries within a 90-day timeframe;
A choice of exam location when CBP selects an entry for examination;
When a single entry contains multiple containers, but only one container is selected for examination, the remaining articles will be released; and
Additional incentives for the companies that complete the Product Safety portion of the Trusted Trader application.

Application Process

Importing companies that are interested in participating in the Trusted Trader Program test and meet the eligibility criteria must submit an email; if they are provisionally selected they will be given the Trusted Trader application. CBP will begin accepting emails on Monday June 16, 2014, and plans to begin selecting the initial test participants no later than July 16, 2014. CBP plans to limit the Trusted Trader program test to fewer than 10 participants. Specifically, CBP is looking for test participants to include at least one importer currently participating in C-TPAT, one importer not currently participating in any CBP partnership programs, and one or two participants monitored by CPSC and FDA.

To be eligible to apply for the Trusted Trader Program test, a company must be an active U.S. or Non-Resident Canadian importer with an Importer of Record or CBP-assigned number and at least two years of importing history. The company must also have written policies and procedures pertaining to its import process, a business office staffed in the United States or Canada, and a valid continuous importation bond filed with CBP. A company must also conduct an assessment of its supply chain based on C-TPAT’s security criteria for importers, implement and maintain security measures and supply chain security practices meeting C-TPAT’s security criteria, have a designated company officer responsible for C-TPAT, and create and provide a C-TPAT security profile. Finally, it must maintain books and records to establish compliance with U.S. Customs laws and regulations.

Through the Trusted Trader Program, CBP will: achieve integrated U.S. government collaborations that will result in enhanced efficiencies leading to a reduction in government-wide resource expenditures; expand information sharing between government agencies; reduce administrative costs by streamlining the application and validation processes; and increase efficiencies in the existing trade programs. Just as CBP has done with C-TPAT, ISA, and the Centers of Excellence and Expertise, the Trusted Trader program should strengthen security, identify low-risk trade entities, and increase overall efficiency of trade by segmenting risk and processing by account.

Article By:

Kathleen M. Murphy

Beata K. Spuhler

Mollie D. Sitkowski

Of:

Drinker Biddle & Reath LLP

Category: Administrative & Regulatory

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