The Lacuna Project

lacuna (n.) a gap in a record where something should be

Independent research. Not affiliated with any government, agency, or company.

Agency

U.S. Department of Health and Human Services

Findings that rest on exhibits naming this entity

  • AGR-1.10: On 10 March 2025 HHS Secretary Kennedy directed FDA to explore rulemaking to eliminate the self-affirmed GRAS pathway. The September 2025 MAHA strategy committed FDA to "closing the 'GRAS loophole,' implementing a mandatory GRAS notification program."
  • AGR-1.12: FDA and USDA published a joint request for information on 25 July 2025 stating there is "no single, universally accepted definition" of ultra-processed food. The comment period was extended to 23 October 2025.
  • AGR-1.13: A proposed federal definition of ultra-processed food went to OMB review as a white paper on 3 August 2026, according to OIRA's review record, and had not been released as of 13 October 2026. The Philadelphia Inquirer, carrying a Bloomberg article, reported on 10 August 2026 that food-company executives lobbied the Trump administration to delay or block its release, according to people familiar with the discussions. STAT reported on 22 October 2026 that the planned release was canceled at the last minute.
  • INF-1.7: GAO reported in November 2006 that direct-to-consumer spending was $4.2 billion in 2005, that FDA reviews a small portion of such materials, and that regulatory letters took an average of 4 months to issue in 2002-2005 against 2 weeks in 1997-2001. By the time the 19 letters of 2004-2005 were issued, companies had stopped using more than half of the cited materials.
  • INF-1.8: FDA issued final guidance on consumer-directed broadcast advertisements in August 1999, after announcing a draft on 12 August 1997. The Food and Drug Administration Amendments Act of 27 September 2007 required FDA to set standards for a clear, conspicuous and neutral major statement in television and radio drug advertisements within 30 months; FDA proposed a rule on 29 March 2010 and published the final rule on 21 November 2023, with compliance required from 20 November 2024.
  • INF-1.9: On 9 September 2025 the President directed HHS and FDA to act on direct-to-consumer drug advertising, and FDA announced thousands of warning letters, about 100 cease-and-desist letters and rulemaking to remove the "adequate provision" option. FDA's announcement states that warning letters to pharmaceutical companies fell to one in 2023 and zero in 2024.
  • POL-1.20: Ballard's Lobbying Disclosure Act reports for RAI Services list "White House Office" among the entities contacted in the second and third quarters of 2026, and list the Food and Drug Administration. The first-quarter 2026 report lists only the House, and the 2025 reports list no White House Office. In those two quarters no other outside lobbying firm for RAI Services lists the White House Office.
  • AGR-2.9: The 2003 WHO/FAO report on diet and chronic disease set a population goal of under 10 percent of energy from free sugars and described that goal as controversial. In March and April 2003, according to AP, CSPI and the Guardian, the Sugar Association's president wrote to WHO that the association would ask Congress to challenge U.S. funding, a food-industry coalition asked HHS Secretary Tommy Thompson to intervene on 20 March, and Senators Larry Craig (R-ID) and John Breaux (D-LA) made a further request to Thompson on 28 March. AP also reports that the senators wrote Agriculture Secretary Ann Veneman.
  • AGR-4.1: The 1990 statute requires the Dietary Guidelines every five years, "based on the preponderance of the scientific and medical knowledge," and does not mention advisory committees, their membership or conflicts of interest. The Congressional Research Service records that appropriations language in 1980 and 1987 directed the external review and advisory group that became the standing committee.
  • AGR-4.4: In 2015 the House Appropriations Committee wrote that the advisory committee's report "included extraneous factors and policy recommendations that are outside of the statutory requirement, such as agriculture production practices including sustainability, taxes, food labeling and marketing policies." Public Law 114-113 section 734 then barred release of the 2015-2020 guidelines unless each guideline "is based on significant scientific agreement" and "is limited in scope to nutritional and dietary information." On 6 October 2015 Secretaries Vilsack and Burwell announced that sustainability would not be in the guidelines "because this is a matter of scope."
  • AGR-4.5: The 2015 advisory committee recommended dropping the 300 mg per day dietary cholesterol limit, and the 2015-2020 guidelines dropped it. Both kept a ceiling of 10 percent of calories from saturated fat.
  • AGR-4.7: A peer-reviewed analysis found that 19 of the 20 members of the 2020 advisory committee (95 percent) had at least one tie to an industry actor, counting 720 relationship-year instances, most of them research funding and board seats. The Nutrition Coalition funded the study, and Teicholz is a co-author.
  • AGR-4.8: For the 2020 committee the USDA ethics official found no entry on any of the 20 members' OGE Form 450 that would prevent appointment. For the same cycle HHS and USDA declined NASEM's recommendations for an external third-party screener (cost and time) and a public list of provisional appointees (privacy). A coalition letter states that OGE Form 450 is exempt from public disclosure.
  • AGR-4.9: NASEM's 2017 reports found the selection process "thoughtful" and not transparent, said conflicts of interest cannot always be eliminated entirely on a balanced panel, recommended public disclosure of how conflicts are identified and managed, and found the step from committee report to guidelines in need of public explanation. Presenters raised USDA's role in both supporting agriculture and managing the guidelines.
  • AGR-4.10: The 2020 advisory committee recommended lowering the added-sugars limit from 10 to 6 percent of calories and the limit for men's alcohol intake from two drinks to one. HHS and USDA did not adopt either.
  • AGR-4.11: The 2025 advisory committee disclosed its members' interests collectively, on voluntary ICMJE forms covering the prior 12 months, and stated: "Because its work is collective, the Committee provided its disclosures collectively rather than individually." A letter signed by CSPI and other organizations on 27 January 2023 had asked for individual disclosure.
  • AGR-4.12: In January 2026 HHS and USDA replaced the 2025 advisory committee report as the evidence base with a review by nine external reviewers selected through a federal contracting process. The departments' disclosure table lists funding or fees from beef, pork or dairy organizations for four of the nine.
  • AGR-4.13: No GAO report in the record evaluates the selection or conflict-of-interest process for the Dietary Guidelines Advisory Committee. GAO-24-106130 covers coordination of interagency nutrition research.
  • POL-5.20: On 3 August 2026 Senator Ron Wyden, ranking member of the Senate Finance Committee, sent letters to Reynolds American, to the Secretary of Health and Human Services and to Botanic Tonics. The letters cite press reports for a chronology of the payments, a lunch and FDA's guidance, ask what was requested at the lunch and in calls, and set a deadline of 31 August 2026.
  • POL-7.8: GAO found that unattributed video news releases produced for HHS and its Centers for Medicare and Medicaid Services (B-302710, 19 May 2004), the Office of National Drug Control Policy (B-303495, 4 January 2005) and the Department of Education (B-304228, 30 September 2005) violated the publicity-or-propaganda prohibition, and in the last two opinions called the news stories "covert propaganda."

Exhibits naming this entity

  • Exhibit 533 22 October 1990. U.S. Congress: National Nutrition Monitoring and Related Research Act of 1990, sec. 301 (7 U.S.C. 5341): Dietary Guidelines for Americans
  • Exhibit 536 28 March 2023. Congressional Research Service: The Dietary Guidelines for Americans: Overview and Considerations for Congress (R47488)
  • Exhibit 539 14 July 2015. U.S. House Committee on Appropriations: House Report 114-205, Agriculture, Rural Development, FDA and Related Agencies Appropriations Bill, 2016
  • Exhibit 540 18 December 2015. U.S. Congress: Consolidated Appropriations Act, 2016, P.L. 114-113, Division A, secs. 734-735
  • Exhibit 541 31 March 2015. U.S. House of Representatives (Members of Congress): Letter from Reps. Hartzler, Conaway and other House members to Secretaries Vilsack and Burwell
  • Exhibit 542 6 October 2015. Secretaries Vilsack (USDA) and Burwell (HHS): 2015 Dietary Guidelines: Giving You the Tools You Need to Make Healthy Choices
  • Exhibit 543 February 2015. 2015 Dietary Guidelines Advisory Committee: Scientific Report of the 2015 Dietary Guidelines Advisory Committee
  • Exhibit 544 7 January 2016. U.S. Department of Health and Human Services and U.S. Department of Agriculture: Dietary Guidelines for Americans 2015-2020, Eighth Edition
  • Exhibit 549 July 2020. 2020 Dietary Guidelines Advisory Committee: Scientific Report of the 2020 Dietary Guidelines Advisory Committee
  • Exhibit 550 May 2019. Eve Stoody, Designated Federal Officer, 2020 DGAC (USDA CNPP): Responding to the National Academies of Sciences, Engineering, and Medicine Study on the Process to Update the Dietary Guidelines for Americans
  • Exhibit 551 September 2017. National Academies of Sciences, Engineering, and Medicine: Optimizing the Process for Establishing the Dietary Guidelines for Americans: The Selection Process
  • Exhibit 552 December 2017. National Academies of Sciences, Engineering, and Medicine: Redesigning the Process for Establishing the Dietary Guidelines for Americans
  • Exhibit 553 27 January 2023. Center for Science in the Public Interest and 12 other organizations: Letter to HHS urging public disclosure of 2025 DGAC members' financial conflicts of interest
  • Exhibit 554 December 2024. 2025 Dietary Guidelines Advisory Committee: Scientific Report of the 2025 Dietary Guidelines Advisory Committee
  • Exhibit 555 7 January 2026. U.S. Department of Health and Human Services and U.S. Department of Agriculture: Dietary Guidelines for Americans, 2025-2030
  • Exhibit 556 8 January 2026. U.S. Department of Health and Human Services and U.S. Department of Agriculture: The Scientific Foundation for the Dietary Guidelines for Americans, 2025-2030
  • Exhibit 557 18 October 2023. U.S. Government Accountability Office: Dietary Guidelines for Americans: Strengthening Interagency Collaboration Could Help Inform Nutrition Research and Future Guidelines (GAO-24-106130)
  • Exhibit 569 10 March 2025. U.S. Department of Health and Human Services: HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe
  • Exhibit 577 23 July 2025. U.S. Department of Health and Human Services: HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods
  • Exhibit 582 October 2026. Greenberg Traurig: More Than Research: Why the Coming Federal Definition of Ultra-Processed Foods Matters
  • Exhibit 593 23 April 2003. Associated Press, via CBS News: Sugar Lobbyists Sour On Study
  • Exhibit 595 2003. Sarah Boseley (reprint of Guardian report of 21 April 2003), International Journal of Health Services 33(4):831-833: Political context of the World Health Organization: sugar industry threatens to scupper the WHO
  • Exhibit 858 19 May 2004. U.S. General Accounting Office (Comptroller General): Department of Health and Human Services, Centers for Medicare & Medicaid Services - Video News Releases, B-302710
  • Exhibit 931 April 2023 (entries last updated 13 March 2023). U.S. Department of Health and Human Services and U.S. Department of Agriculture (dietaryguidelines.gov): 2025 Dietary Guidelines Advisory Committee Disclosures
  • Exhibit 932 25 May 2023. Sen. Charles E. Grassley: Grassley Calls on Nutrition Advisory Committee to Halt Dietary Recommendations Until Conflicts of Interest Are Resolved (press release)
  • Exhibit 933 25 May 2023. Sen. Charles E. Grassley: Letter, Sen. Grassley to Secretaries Becerra and Vilsack on the 2025 Dietary Guidelines Advisory Committee
  • Exhibit 935 Archived 18 December 2020 (page undated). U.S. Department of Agriculture and U.S. Department of Health and Human Services (dietaryguidelines.gov): Dietary Guidelines for Americans: Most Popular Questions (2020 Advisory Committee process and ethics review)
  • Exhibit 942 January 2023. U.S. Department of Health and Human Services, Office of Inspector General: The National Institutes of Health and EcoHealth Alliance Did Not Effectively Monitor Awards and Subawards, Resulting in Missed Opportunities to Oversee Research and Other Deficiencies (A-05-21-00025)
  • Exhibit 986 November 2006. U.S. Government Accountability Office: Prescription Drugs: Improvements Needed in FDA’s Oversight of Direct-to-Consumer Advertising, GAO-07-54
  • Exhibit 987 27 September 2007. United States Congress: Food and Drug Administration Amendments Act of 2007, Pub. L. 110-85, Title IX, sec. 901(d)(3) and (4) (clear, conspicuous and neutral major statement; civil penalties for false or misleading DTC advertisements)
  • Exhibit 988 21 November 2023. U.S. Food and Drug Administration: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format, final rule, 88 Fed. Reg. 80958
  • Exhibit 989 9 September 2025. U.S. Food and Drug Administration: FDA Launches Crackdown on Deceptive Drug Advertising (press release)
  • Exhibit 990 9 September 2025. The White House (President Donald J. Trump): Memorandum on Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
  • Exhibit 1013 30 September 2005. U.S. Government Accountability Office: Department of Health and Human Services, Contract with Maggie Gallagher, B-304716
  • Exhibit 1291 filed 2025-04-19 to 2026-10-18. U.S. Congress (Lobbying Disclosure Act database, lda.gov): Ballard Partners LD-2 reports for client RAI Services Company, first quarter 2025 to third quarter 2026
  • Exhibit 1296 3 August 2026. U.S. Senate Committee on Finance, Democratic staff: Letter, Senator Ron Wyden to HHS Secretary Robert F. Kennedy, Jr.
  • Exhibit 1299 12 May 2026. U.S. Food and Drug Administration, HHS (Federal Register): Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability, 91 FR 25892