October 19, 2021

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Florida Man Pleads Guilty to Conspiracy to Defraud FDA in Connection with Dietary Supplements

10 min read
<div>A Florida man pleaded guilty today to conspiring to defraud the U.S. Food and Drug Administration (FDA) by concealing information about illegal products labeled as dietary supplements.</div>
A Florida man pleaded guilty today to conspiring to defraud the U.S. Food and Drug Administration (FDA) by concealing information about illegal products labeled as dietary supplements.

More from: September 2, 2021

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  • Financial Services Industry: Using Data to Promote Greater Diversity and Inclusion
    In U.S GAO News
    What GAO Found GAO's prior work has shown that the financial services industry has made little or no progress in increasing diversity at the senior management level. The figure below shows the latest available data on diversity at senior levels. Race/Ethnicity and Gender Representation of Executive/Senior-Level Management in the Financial Services Industry, 2018 One common theme of GAO's recent reports on diversity in the financial services industry is the importance of using data to assess diversity and inclusion efforts. In 2017, GAO reported that financial services firms said it is important for firms to collect and analyze data to assess workforce diversity. Notably, all the financial services firms with which GAO spoke agreed on the importance of analyzing employee data. Some firm representatives noted that with such data, they can analyze the gender and racial/ethnic diversity of new hires, employees leaving the organization, and newly promoted staff and managers. In 2019 and 2020, GAO reported that the Federal Home Loan Banks (FHLBanks) and Fannie Mae and Freddie Mac (the enterprises) track diversity composition data on their workforce, recruitment, and hiring. The FHLBanks and the enterprises use these data to compare their performance against benchmarks, such as prior-year metrics and peer institutions, and set goals for future performance. They also incorporate diversity targets into their incentive compensation goals or performance competencies for management. The Federal Housing Finance Agency (FHFA) uses data to oversee the workforce diversity and inclusion efforts of the FHLBanks and the enterprises. As GAO reported in 2019 and 2020, FHFA collects and reviews quarterly and annual workforce diversity data from the FHLBanks and enterprises. For example, FHFA assesses each FHLBank's performance in workforce diversity using the quarterly data. In 2017, FHFA also began reviewing diversity and inclusion efforts as part of its annual examinations of the FHLBanks and the enterprises. Why GAO Did This Study The financial services industry provides services that help families build wealth and is essential to the economic growth of the country. For instance, the FHLBanks, Fannie Mae, and Freddie Mac play important roles in supporting the U.S. housing market. The FHLBanks include 11 federally chartered banks that provide liquidity for member institutions, such as commercial and community banks, to use in support of housing finance and community lending. Fannie Mae and Freddie Mac purchase single-family and multifamily mortgage loans that lenders already made to borrowers. Congressional members and others have highlighted the need for the financial services industry to create opportunities for all Americans, including supporting a diverse workforce. This statement discusses (1) how financial service firms use data to assess workforce diversity efforts; (2) how the FHLBanks and the enterprises use data to assess their diversity efforts; and (3) how FHFA oversees diversity efforts at the FHLBanks and the enterprises. This statement is primarily based on three GAO reports (GAO-18-64, GAO-19-589, and GAO-20-637) on diversity efforts in the financial services industry and at FHLBanks and the enterprises. For the reports, GAO reviewed relevant literature and data, and interviewed representatives of financial services firms and industry and diversity advocacy organizations. GAO also reviewed documents and interviewed officials from the FHLBanks, enterprises, and FHFA. For more information, contact Daniel Garcia-Diaz at (202) 512-8678 or GarciaDiazD@gao.gov.
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  • Rule of Law Assistance: Agency Efforts Are Guided by Various Strategies, and Overseas Missions Should Ensure that Programming Is Fully Coordinated
    In U.S GAO News
    What GAO Found The Department of State (State) and the U.S. Agency for International Development (USAID) allocated more than $2.7 billion for rule of law assistance from fiscal years 2014 through 2018—the latest available data as of GAO's review. Of that, State allocated over $2 billion and USAID allocated over $700 million. State and USAID funded some of these programs through the Department of Justice (DOJ). Rule of law assistance funded a variety of activities including improving justice institutions, legal reform, and promoting a culture of lawfulness. The agencies implemented these programs globally but allocated most funds to the Western Hemisphere and Afghanistan. Global Distribution of Bilateral Rule of Law Assistance Allocations, Fiscal Years 2014–2018 After Congress appropriates funding, agencies determine rule of law allocations through the foreign assistance budget process. State and USAID identify rule of law as a goal in agency-wide strategic documents and hold an annual interagency roundtable regarding rule of law assistance to determine those allocations. Rule of law assistance is guided by national and agency-, bureau-, and mission-specific strategies that are linked to the national security goals of the United States. These strategies discuss the agencies' roles and responsibilities in improving the rule of law. State and USAID guidance highlights the importance of coordination between agencies as they design and implement rule of law assistance, but not all agencies are included in some of the key coordination mechanisms used in four countries GAO selected for review. Agency officials in the selected countries cited the use of some informal and formal coordination practices, such as the use of law enforcement working groups, but State policy does not require all entities that may be involved in rule of law assistance to participate in these working groups. For example, in three of the four selected countries, officials described coordinating rule of law assistance, in part, through these working groups, which may not include critical agencies such as USAID. According to State policy, these working groups are designed to achieve other goals using agencies and offices that are not involved in providing rule of law assistance. Without verifying that interagency coordination includes all relevant entities, missions may not know whether they are fully leveraging interagency resources or ensuring that they do not duplicate or overlap rule of law assistance. Why GAO Did This Study Rule of law strengthens protection of fundamental rights, ensures a robust civil society, and serves as a foundation for democratic governance and economic growth. According to State, countries with a strong rule of law provide a more level playing field for American businesses to engage and compete, and countries with a weak rule of law can potentially export transnational threats and economic insecurity, undermining the interests of the United States. GAO was asked to review U.S. rule of law assistance around the world. This report examines (1) how State and USAID allocated funds for this assistance in fiscal years 2014 through 2018, (2) how agencies strategically plan and allocate this assistance globally, and (3) what processes agencies have to design, implement, and coordinate this assistance in selected countries. GAO reviewed State, USAID, and DOJ documents and data for fiscal years 2014 through 2018 and interviewed officials in Colombia, Kosovo, Liberia, the Philippines, and Washington, D.C. GAO chose these countries on the basis of funding amounts and other factors.
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  • Economic Injury Disaster Loan Program: Additional Actions Needed to Improve Communication with Applicants and Address Fraud Risks
    In U.S GAO News
    What GAO Found Economic Injury Disaster Loan (EIDL) applicants and recipients varied in terms of business size, years in operation, and industry, based on GAO's analysis of Small Business Administration (SBA) data from March 2020 through February 2021: Business size. A majority of EIDL applicants (about 81 percent) and EIDL recipients (about 86 percent) were smaller businesses (10 or fewer employees). Years in operation. A majority of EIDL applicants (about 63 percent) had been in operation for less than 5 years. However, businesses in operation for more than 5 years received the majority of total EIDL loan dollars and had higher approval rates compared to newer businesses. Industry. Businesses in the personal services and transportation industries made up the largest share of applicants, while those in the legal services and lodging industries were approved for loans at the highest rates (see figure). Top Loan Applicants and Approval Rates by Business Industry In addition, small businesses in counties with higher median household income, better internet access, and more diverse populations generally received more loans per 1,000 businesses and larger loans. EIDL applicants have faced a number of challenges, according to applicants and other business stakeholders GAO interviewed between August 2020 and February 2021. For example, applicants from five discussion groups and several stakeholders cited lack of information and uncertainty about application status as major concerns. In addition, until February 2021, SBA did not provide important information to potential applicants, such as limits on loan amounts and definitions of certain program terms. Lack of important program information and application status put pressure on SBA's resources and negatively affected applicants' experience. For example, SBA's customer service line experienced call surges that resulted in long wait times, and SBA's data showed that 5.3 million applications were duplicates. SBA's planning documents describe in general terms the public outreach to be conducted following disasters, but they do not detail the type or timing of the information to be provided. Developing and implementing a comprehensive communication strategy that includes these details could improve the quality, clarity, and timeliness of information SBA provides to its applicants and resource partners following catastrophic disasters. GAO's ongoing review of the EIDL program related to COVID-19 has found that the program is susceptible to providing funding to ineligible and fraudulent applicants. For example, as GAO reported in January 2021, SBA had approved at least 3,000 loans totaling about $156 million to businesses that SBA policies state were ineligible for the EIDL program, such as real estate developers and multilevel marketers, as of September 30, 2020. In addition, GAO found that between May and October 2020, over 900 U.S. financial institutions filed more than 20,000 suspicious activity reports related to the EIDL program with the Financial Crimes Enforcement Network. Further, GAO's analysis of 51 Department of Justice cases involving fraud charges for EIDL loans as of March 2021 found that these cases involved identity theft, false attestation, fictitious or inflated employee counts, and misuse of proceeds. Over the course of its COVID-19 response, SBA has made some changes to address these risks. For example, beginning in June 2020, SBA took actions to improve loan officers' ability to withhold funding for applicants suspected of fraud. However, SBA has not yet implemented recommendations GAO has previously made to address EIDL program risks. In January 2021, GAO recommended that SBA conduct data analytics across the EIDL portfolio to detect potentially ineligible and fraudulent applications (GAO-21-265). SBA did not agree or disagree with this recommendation. However, in May 2021, SBA officials stated the agency was in the process of developing analysis to apply certain fraud indicators to all application data.   In March 2021, GAO recommended that SBA (1) implement a comprehensive oversight plan to identify and respond to risks in the EIDL program, (2) conduct and document a fraud risk assessment, and (3)  develop a strategy to address the program’s assessed fraud risks on a continuous basis (GAO-21-387). SBA agreed with all three recommendations. In May 2021, SBA officials stated that the agency had started to assess fraud risk for the program. Fully implementing these recommendations would help SBA to safeguard billions of dollars of taxpayer funds and improve the operation of the EIDL program. Why GAO Did This Study Between March 2020 and February 2021, SBA provided about 3.8 million low-interest EIDL loans and 5.8 million grants (called advances) totaling $224 billion to help small businesses adversely affected by COVID-19. Borrowers can use these low-interest loans and advances to pay for operating and other expenses. The CARES Act includes a provision for GAO to monitor funds provided for the COVID-19 pandemic. This report examines, among other objectives, the characteristics of program applicants and recipients; the challenges EIDL applicants experienced and the extent to which SBA has addressed them; and the steps SBA has taken to address risks of fraud and provision of funds to ineligible applicants. GAO reviewed documents from SBA, an EIDL contractor, and two of its subcontractors. In addition, GAO analyzed loan application data, conducted five discussion groups with applicants, and interviewed staff from SBA, six Small Business Development Centers, and six business associations. GAO also analyzed socioeconomic, demographic, and geographic data on EIDL program participants.
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  • Commercial Space Transportation: FAA Continues to Update Regulations and Faces Challenges to Overseeing an Evolving Industry
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    What GAO Found The Federal Aviation Administration (FAA) recently updated and streamlined its launch and reentry licensing regulations but has made less progress on other key commercial space transportation regulations. The new licensing regulations, issued in December 2020, replaced prescriptive requirements—in which a certain technology or action was required—with a performance-based regulatory framework, which provides applicants flexibility in how they achieve required outcomes, such as a specific level of safety. Given its focus on the licensing regulations, FAA placed on hold revisions to other regulations governing commercial space transportation—revisions which, according to FAA officials, are warranted given the industry's evolution. For example, FAA has not yet begun to revise its financial responsibility regulations, which require launch companies conducting FAA-licensed launches to purchase insurance to cover damage to third parties in case of a launch mishap. According to FAA officials, revising these regulations is their next planned rulemaking and when finalized, will respond to GAO's recommendations to improve FAA's methodologies for evaluating and calculating potential third-party losses from launch and reentry mishaps and help ensure the federal government is not exposed to greater liability than expected. FAA also faces ongoing challenges regulating an evolving industry. In particular, as GAO previously reported, FAA continues to face the challenge of whether and when to regulate the safety of crew and spaceflight participants. While some companies have announced plans to take tourists to space within the next several years, FAA is prohibited by statute from regulating crew and passenger safety before 2023, except in response to events that caused or posed a risk of serious or fatal injury. However, FAA has taken some steps in anticipation of the expiration of the statutory moratorium, such as working with its industry advisory committee to develop and disseminate human spaceflight best practices. FAA also has taken some steps to help the agency keep pace with changes in the industry. For example, in response to recommendations GAO made in 2019, FAA recently assessed its workforce to identify skills and competencies that are needed among its workforce and is working to improve its workload projections to better account for the full range of its regulatory activities and the timeline of its licensing process. Such efforts are critical for ensuring FAA can better anticipate and respond to the growing and evolving commercial space industry and FAA's emerging workforce needs. Why GAO Did This Study The commercial space transportation industry provides launch services for government and private customers that carry objects, such as satellites and vehicles with scientific research, or passengers to or from space. Continued growth and evolution in the industry is expected as reliance on space-based applications increases. Within FAA, the Office of Commercial Space Transportation (AST) is charged both with overseeing the industry, including licensing and monitoring launch vehicle operations, and promoting the industry. This statement describes FAA's efforts to update regulations governing commercial space transportation; challenges FAA faces regulating an evolving industry; and steps FAA has taken to help ensure it is positioned to meet the needs of the evolving industry. This statement is based largely on GAO's body of work on commercial space transportation, including GAO-19-437 issued in May 2019. To update this information, GAO interviewed FAA officials and reviewed applicable statutes, regulations and selected industry documents.
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  • Offshore Wind Energy: Planned Projects May Lead to Construction of New Vessels in the U.S., but Industry Has Made Few Decisions amid Uncertainties
    In U.S GAO News
    Under the Jones Act, vessels carrying merchandise between two points in the U.S. must be built and registered in the United States. Developers are planning a number of offshore wind projects along the U.S. east coast, where many states have set targets for offshore wind energy production. Stakeholders described two approaches to using vessels to install offshore wind energy projects in the U.S. Either approach may lead to the construction of new vessels that comply with the Jones Act. Under one approach, a Jones Act-compliant wind turbine installation vessel (WTIV) would carry components from a U.S. port to the site and also install the turbines. WTIVs have a large deck, legs that allow the vessel to lift out of the water, and a tall crane to lift and place turbines. Stakeholders told GAO there are currently no Jones Act-compliant vessels capable of serving as a WTIV. One company, however, has announced a plan to build one. Under the second approach, a foreign-flag WTIV would install the turbines with components carried to the site from U.S. ports by Jones Act-compliant feeder vessels (see figure). While some potential feeder vessels exist, stakeholders said larger ones would probably need to be built to handle the large turbines developers would likely use. Example of an Offshore Wind Installation in U.S. Waters Using a Foreign-Flag Installation Vessel and Jones Act-Compliant Feeder Vessels Stakeholders identified multiple challenges—which some federal programs address—associated with constructing and using Jones Act-compliant vessels for offshore wind installations. For example, stakeholders said that obtaining investments in Jones Act-compliant WTIVs—which may cost up to $500 million—has been challenging, in part due to uncertainty about the timing of federal approval for projects. According to officials at the Department of the Interior, which is responsible for approving offshore wind projects, the Department plans to issue a decision on the nation's first large-scale offshore wind project in December 2020. Some stakeholders said that if this project is approved, investors may be more willing to move forward with vessel investments. While stakeholders also said port infrastructure limitations could pose challenges to using Jones Act-compliant vessels for offshore wind, offshore wind developers and state agencies have committed to make port investments. Offshore wind, a significant potential source of energy in the United States, requires a number of oceangoing vessels for installation and other tasks. Depending on the use, these vessels may need to comply with the Jones Act. Because Jones Act-compliant vessels are generally more expensive to build and operate than foreign-flag vessels, using such vessels may increase the costs of offshore wind projects. Building such vessels may also lead to some economic benefits for the maritime industry. A provision was included in statute for GAO to review offshore wind vessels. This report examines (1) approaches to use of vessels that developers are considering for offshore wind, consistent with Jones Act requirements, and the extent to which such vessels exist, and (2) the challenges industry stakeholders have identified associated with constructing and using such vessels to support U.S. offshore wind, and the actions federal agencies have taken to address these challenges. GAO analyzed information on vessels that could support offshore wind, reviewed relevant laws and studies, and interviewed officials from federal agencies and industry stakeholders selected based on their involvement in ongoing projects and recommendations from others. For more information, contact Andrew Von Ah at (202) 512-2834 or vonaha@gao.gov.
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  • K-12 Education: Challenges Locating and Securing Charter School Facilities and Government Assistance
    In U.S GAO News
    Why GAO Did This Study Charter schools are public schools established under charters, typically with state or local entities, and have more flexibility and autonomy. In exchange, charter schools must meet specific accountability standards. GAO was asked to examine the extent to which charter schools had access to public facilities and the costs associated with such access. This report examines (1) challenges faced by charter schools in locating and securing facilities and (2) select programs available to help charter schools address challenges when locating and securing facilities. To answer these questions, GAO conducted individual and group interviews with state, school district, and charter school officials in California and Colorado, which were selected based on the variety of their programs, among other factors. In addition, GAO interviewed Department of Education officials and other stakeholders. GAO also reviewed agency documents and relevant federal and state laws, regulations, and policies. What GAO Found From school year 2002-2003 to school year 2018-2019 (most recent national data available) the number of charter schools increased from about 2,700 to 7,400 and the number of enrolled students increased from about 700,000 to about 3.3 million. Consistent with prior GAO work in 2000 and 2003, charter schools continue to face challenges locating and securing facilities. GAO identified four key challenges based on interviews with state, school district, and charter school officials in California and Colorado, as well as representatives of nonprofit organizations that provide affordable loans to assist charter schools, and other stakeholders: Affordability. Limited access to state and local funding and affordable private loans as well as rising real estate costs and renovation expenses. Availability. Lack of amenities (e.g., a cafeteria or playground) or safe and secure building space and limited access to public or private buildings. Lack of consistent local support. Inconsistent assistance by local governments and school districts for charter school facilities' needs. Capacity to manage facilities. Limited expertise in facilities management. Various state and federal programs may assist charter schools with challenges locating and securing facilities. In the two states GAO reviewed, California and Colorado, programs that assist charter schools with facilities funding or building space include per-pupil allowances, grant programs, local bond measures, and use of school district facilities. In addition, federal agencies, such as the Department of Education and the Department of Agriculture, provide grants and loans to help charter schools acquire facilities. For example, Education has two facilities-focused competitive grant programs, including one that allows funds to be used for a state's per-pupil facility allowance. Education's National Charter School Resource Center assists charter schools by providing information and other resources related to facilities. For more information, contact Jacqueline M. Nowicki at (617) 788-0580 or nowickij@gao.gov.  
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