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. Food and Drug Administration

Documented positions

  • David C. Kaslow: Vice president, vaccines and infectious disease, Merck Research Laboratories, Merck (earlier – 2012); Chief scientific officer, PATH (2012 – 2022); Director, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (2022-10-11 – present)

Documented money flows

Findings that rest on exhibits naming this entity

  • AGR-1.1: The Food Additives Amendment of 1958 makes a food additive unsafe unless an FDA regulation or exemption covers it, and it excludes from the definition of food additive any substance generally recognized, among experts qualified by scientific training and experience, as safe for its intended use. The statute does not say who the experts are or that a company must tell FDA of its conclusion.
  • AGR-1.2: FDA's 1997 proposal and 2016 final rule made notification of a GRAS conclusion voluntary. The 2016 rule treats a conclusion kept by its maker the same in law as one submitted to FDA, and it states that FDA lacks express statutory authority to require notices.
  • AGR-1.3: The Center for Food Safety and the Environmental Defense Fund challenged FDA's 2016 GRAS rule in the Southern District of New York. According to the Congressional Research Service, the court granted summary judgment to FDA because FDA's reading of the Act was reasonable, and the plaintiffs did not appeal.
  • AGR-1.4: GAO reported in 2010 that FDA reviews only the GRAS determinations companies submit, generally has no information about the others, and cannot estimate how many it was not told of. GAO also found that FDA had issued no conflict-of-interest guidance for the expert panels companies convene and did not ask for information on panelists' independence in GRAS notices.
  • AGR-1.7: FDA's 2026 economic analysis states that the exact number of substances marketed under independent GRAS conclusions is unknown and assumes 1,000 to 3,000 (primary estimate 2,000), against 1,309 notices filed from February 1998 to March 2025. The proposed rule states that FDA "cannot verify the accuracy of these estimates."
  • AGR-1.8: FDA's regulation says general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as an additive approval. FDA removed cyclamate salts from the GRAS list in 1969, and in 2010 it sent warning letters to makers of caffeinated alcoholic beverages that had made no GRAS determination.
  • AGR-1.9: Sodium carboxymethylcellulose is listed in FDA's regulations as generally recognized as safe when used in accordance with good manufacturing practice (21 CFR 182.1745). In a double-blind controlled-feeding study of 16 healthy adults, 15 g per day of carboxymethylcellulose for 11 days reduced gut microbiota diversity and changed the fecal metabolome relative to controls, and the study reported no disease outcome.
  • 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-1.11: FDA's proposed rule of 11 August 2026 would require GRAS notices for substances purported to be GRAS, with a one-year streamlined submission for substances already on the market. The rule creates no premarket approval, lets companies market a substance before notifying and while FDA reviews the notice, and makes failure to notify "a factor" in FDA's prioritization for post-market review.
  • 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.
  • AGR-1.16: Whether California's database-based definition of ultraprocessed food reaches additives marketed on independent GRAS conclusions is unanswered. The definition relies on FDA's Substances Added to Food database, and FDA states that it has "little, if any, information on independent conclusions of GRAS status."
  • INF-1.6: A 2019 JAMA study reports that direct-to-consumer prescription-drug advertising grew from $1.3 billion (79,000 ads) in 1997 to $6 billion (4.6 million ads, 663,000 of them TV commercials) in 2016, in 2016 dollars, and that FDA violation letters for misleading drug marketing fell from 156 to 11.
  • 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.
  • REL-5.6: On 6 March 2020 the Food and Drug Administration and the Federal Trade Commission sent a joint warning letter to The Jim Bakker Show about silver products promoted for COVID-19. The letter states FDA's determination that the products are unapproved new drugs. The records found show no FTC court action.
  • MED-6.10: FDA authorized four Glas e-cigarette pods on 5 May 2026, which it described as its first authorizations of non-tobacco, non-menthol e-cigarettes. A March 2026 draft guidance on flavored e-cigarette applications states that where the evidence shows comparatively lower youth initiation risk, FDA may consider a correspondingly lower magnitude of adult benefit necessary to support authorization.

Exhibits naming this entity

  • Exhibit 458 6 March 2020. U.S. Food and Drug Administration and Federal Trade Commission: Warning Letter to The Jim Bakker Show (MARCS-CMS 604820)
  • Exhibit 558 6 September 1958. U.S. Congress: Food Additives Amendment of 1958 (Public Law 85-929, 72 Stat. 1784)
  • Exhibit 559 2006 (poster; page accessed 2026). U.S. Food and Drug Administration, Office of Food Additive Safety: FDA's Approach to the GRAS Provision: A History of Processes
  • Exhibit 560 17 April 1997. U.S. Food and Drug Administration: Substances Generally Recognized as Safe, proposed rule (62 FR 18938; Docket 97N-0103)
  • Exhibit 561 17 August 2016. U.S. Food and Drug Administration: Substances Generally Recognized as Safe, final rule (81 FR 54960; Docket FDA-1997-N-0020)
  • Exhibit 562 February 2010. U.S. Government Accountability Office: Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) (GAO-10-246)
  • Exhibit 564 25 October 2011. Neltner TG, Kulkarni NR, Alger HM, Maffini MV, Bongard ED, Fortin ND, Olson ED (Pew Health Group): Navigating the U.S. Food Additive Regulatory Program (Comprehensive Reviews in Food Science and Food Safety 10(6):342-368)
  • Exhibit 567 In force 1 November 2026 (eCFR). U.S. Food and Drug Administration: 21 CFR 170.30, Eligibility for classification as generally recognized as safe (GRAS)
  • Exhibit 568 In force 1 November 2026 (eCFR). U.S. Food and Drug Administration: 21 CFR 182.1745, Sodium carboxymethylcellulose
  • 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 570 11 August 2026. U.S. Food and Drug Administration: Substances Generally Recognized as Safe, proposed rule (91 FR 51834; Docket FDA-2025-N-3262; RIN 0910-AJ02)
  • Exhibit 571 August 2026. U.S. Food and Drug Administration, Office of Economics and Analysis: Substances Generally Recognized as Safe: Preliminary Regulatory Impact Analysis (Docket FDA-2025-N-3262)
  • Exhibit 572 5 October 2026. Congressional Research Service: Food Additives and GRAS Substances: A Legal Framework (CRS Legal Sidebar LSB11445)
  • Exhibit 575 25 July 2025. U.S. Food and Drug Administration; U.S. Department of Agriculture: Ultra-Processed Foods; Request for Information (90 FR 35305; Docket FDA-2025-N-1793)
  • Exhibit 576 19 September 2025. U.S. Food and Drug Administration; U.S. Department of Agriculture: Ultra-Processed Foods; Request for Information; Extension of Comment Period (90 FR 45229)
  • 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 583 August 2026. Office of Information and Regulatory Affairs, reginfo.gov: OIRA review record: HHS/FDA ultra-processed food whitepaper (RIN 0910-ZD60)
  • Exhibit 943 6 January 2022. U.S. District Court, Northern District of Texas (Fort Worth Division), Judge Mark T. Pittman: Public Health and Medical Professionals for Transparency v. Food and Drug Administration, No. 4:21-cv-1058-P (N.D. Tex.), order on the production schedule (ECF No. 35)
  • Exhibit 984 August 1999. U.S. Food and Drug Administration (CDER, CBER, CVM): Guidance for Industry: Consumer-Directed Broadcast Advertisements
  • Exhibit 985 9 August 1999. U.S. Food and Drug Administration: Guidance for Industry on Consumer-Directed Broadcast Advertisements; Availability, 64 Fed. Reg. 43197 (Docket 97D-0302)
  • 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 991 8 May 2008. U.S. House of Representatives: Opening statement of Hon. Bart Stupak, “Direct-to-Consumer Advertising: Marketing, Education, or Deception?” (Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce)
  • Exhibit 992 January 2019. Schwartz LM, Woloshin S, JAMA 321(1):80-96 (Dartmouth Institute): Medical Marketing in the United States, 1997-2016
  • Exhibit 1181 2003. Carpenter, Chernew, Smith and Fendrick, Health Affairs (web exclusive) 22(Suppl 1):W3-618-W3-624: Approval Times for New Drugs: Does the Source of Funding for FDA Staff Matter?
  • Exhibit 1182 27 March 2008. Carpenter, Zucker and Avorn, New England Journal of Medicine 358(13):1354-1361: Drug-Review Deadlines and Safety Problems
  • Exhibit 1183 March 2008. Mary K. Olson, Journal of Health Economics 27(2):175-200: The Risk We Bear: The Effects of Review Speed and Industry User Fees on New Drug Safety
  • Exhibit 1184 2024. Erika Lietzan, Administrative Law Review 76(2):375-: User Fee Programs (report to the Administrative Conference of the United States, published in Administrative Law Review)
  • Exhibit 1185 Fall 2013. Light, Lexchin and Darrow, Journal of Law, Medicine and Ethics 41(3):590-600: Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs
  • Exhibit 1268 30 September 2022. U.S. Congress: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, Pub. L. 117-180, Division F (FDA User Fee Reauthorization Act of 2022), sec. 1005
  • Exhibit 1269 29 December 2022. U.S. Congress: Consolidated Appropriations Act, 2023, Pub. L. 117-328, Div. FF (Food and Drug Omnibus Reform Act of 2022), sec. 3210, Modernizing accelerated approval
  • Exhibit 1270 16 August 2021. Food and Drug Administration: Prescription Drug User Fee Rates for Fiscal Year 2022, 86 FR 45732
  • Exhibit 1271 7 October 2022. Food and Drug Administration: Prescription Drug User Fee Rates for Fiscal Year 2023, 87 FR 61063
  • Exhibit 1272 28 July 2023. Food and Drug Administration: Prescription Drug User Fee Rates for Fiscal Year 2024, 88 FR 48881
  • Exhibit 1277 29 October 1992. United States Congress: Prescription Drug User Fee Act of 1992, Pub. L. 102-571, Title I
  • Exhibit 1278 21 November 1997. United States Congress: Food and Drug Administration Modernization Act of 1997, Pub. L. 105-115, Title I, Subtitle A (first PDUFA reauthorization)
  • Exhibit 1279 12 June 2002. United States Congress: Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L. 107-188, Title V, Subtitle A (Prescription Drug User Fee Amendments of 2002)
  • Exhibit 1280 9 July 2012. United States Congress: Food and Drug Administration Safety and Innovation Act, Pub. L. 112-144, Title I (Prescription Drug User Fee Amendments of 2012)
  • Exhibit 1281 18 August 2017. United States Congress: FDA Reauthorization Act of 2017, Pub. L. 115-52, Title I (Prescription Drug User Fee Amendments of 2017)
  • Exhibit 1282 30 September 2022. United States Congress: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, Pub. L. 117-180, Division F, Title I (Prescription Drug User Fee Amendments of 2022)
  • Exhibit 1283 September 2002. U.S. General Accounting Office: Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities (GAO-02-958)
  • Exhibit 1284 Content current as of 15 May 2026. U.S. Food and Drug Administration: FDA Leadership 1907 to Today: Commissioners (term dates)
  • 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 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
  • Exhibit 1300 March 2026. U.S. Food and Drug Administration, Center for Tobacco Products: Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications: Considerations Related to Youth Risk (draft guidance)
  • Exhibit 1301 5 May 2026. U.S. Food and Drug Administration: FDA Expands Market Access, Authorizes New ENDS Products
  • Exhibit 1302 12 March 2026. U.S. Food and Drug Administration, Center for Tobacco Products: Marketing granted orders to Glas Inc., PM0004879.PD6 and PD8
  • Exhibit 1303 read 10 November 2026. U.S. Food and Drug Administration: FDA leadership: Acting Commissioners (Kyle Diamantas, 15 May 2026 to present)
  • Exhibit 1304 12 May 2026. Georgia Public Broadcasting (Sydney Lupkin): FDA commissioner resigns after tumultuous tenure