Browse regulations

FDA regulation exempting specific color additives (annatto, astaxanthin, β-carotene, etc.) from pre-market certification while setting purity standards, usage limits, and labeling requirements.

Deletion would force safe, established colorants through costly certification, raising food prices without safety improvements. This exemption appropriately reduces regulatory burden while maintaining minimal public health safeguards through clear standards, balancing legitimate food safety oversight with free market principles.

This regulation establishes a comprehensive petition process for color additive approval, requiring detailed safety data, manufacturing information, and labeling specifications before FDA can list a color additive for use in food, drugs, cosmetics, or body coloring. The process includes multiple review stages, public disclosure requirements, and batch certification provisions to ensure safety and prevent consumer deception.

The regulatory burden on color additive approval creates unnecessary barriers to innovation while failing to account for market-based safety mechanisms. Private certification, consumer choice, and tort liability provide superior protection without the $2+ trillion compliance costs and bureaucratic delays that prevent safer alternatives from reaching market.

This regulation establishes the FDA's comprehensive framework for approving and regulating color additives in food, drugs, cosmetics, and medical devices. It includes definitions, certification requirements, a fee-based petition system ($2,600-$3,000 base fees plus additional charges), a 'safe-for-use' proof requirement, a zero-tolerance 'Delaney clause' for carcinogens, labeling mandates, and allocation procedures for competing claims.

This regulation imposes crushing compliance costs and violates the rule of law through the scientifically impossible Delaney clause (zero cancer risk). The pre-market approval regime creates regulatory capture, protecting incumbents from competition while disproportionately destroying small businesses through complex, expensive requirements. The legitimate safety objectives could be achieved through post-market liability and state inspection systems at a fraction of the cost, without the hidden $14,000+ annual tax burden on American households from federal regulatory compliance.

Implements Privacy Act of 1974 at the FDA. Governs Privacy Act Record Systems—systems of records about individuals retrieved by name or personal identifier. Establishes procedures for publishing system notices, individual requests for notification/access/amendment, exemptions, contractor compliance, and special rules for medical and personnel records.

Imposes substantial administrative costs and complexity, violating the rule of law principle that regulations must be knowable. Creates procedural barriers that deter individuals from accessing their records, while the hidden tax burden falls on households. Unseen effects include a self-perpetuating compliance bureaucracy and the normalization of permission-based access to government-held information, which undermines transparency and liberty.

FDA regulations governing Freedom of Information Act (FOIA) procedures, including request processing, record disclosure, exemptions, fees, and timelines for public access to agency records.

Americans would be worse off without transparent government access to FDA records, which enables public oversight of drug safety, food safety, and medical device approvals that directly affect health and lives.

Governing ethical standards, conflict-of-interest reviews, and post-employment restrictions for FDA employees to prevent corruption.

Redundant with existing federal ethics laws administered by OGE/DOJ; adds bureaucratic overhead and compliance burden without marginal benefit. Existing criminal statutes (18 U.S.C. §§ 201, 203, 208, 209) already prohibit conflicts and corruption. The post-employment restrictions unnecessarily infringe economic liberty and deter expert participation. Unseen cost: compliance culture distracts from FDA's core mission and contributes to the broader administrative burden on government.

This regulation establishes the FDA's enforcement procedures for violations of the Federal Food, Drug, and Cosmetic Act, detailing recall classifications (Class I-III), recall strategies (depth, public warnings, effectiveness checks), notification requirements, status reporting, and criminal prosecution procedures including 'opportunity to present views.'

The regulation imposes significant compliance costs and procedural burdens on businesses, particularly small firms, while representing federal overreach into product safety that should be handled by states, tort law, and private certification. Its complex bureaucratic machinery distorts incentives and creates barriers to entry, contradicting principles of liberty and free enterprise. Market forces and existing fraud laws provide adequate protection without this expansive federal apparatus.

This regulation establishes FDA procedures for handling official samples of food, drugs, and cosmetics, including collection requirements, analysis protocols, and distribution of sample portions to affected parties. It also covers treatment requirements for poisonous seeds, contamination prevention for used containers, ammonia content determination, and essential uses of ozone-depleting substances in medical products.

This represents massive regulatory overreach that imposes compliance costs on businesses, creates barriers to market entry, and substitutes bureaucratic judgment for private property rights and voluntary exchange. The sample collection requirements alone create a surveillance apparatus over food and drug commerce, while the ozone-depleting substance rules interfere with medical innovation and patient access to treatments.

Regulations establishing FDA authority to enforce food, drug, cosmetic, and device labeling requirements, including definitions of terms, exemptions for certain packaging, and import data submission requirements for regulated products entering the United States.

Americans would be worse off if this regulation was deleted because it ensures consumers can make informed choices about products they purchase, protects public health through proper labeling of food and drugs, and maintains safety standards for imported products that could otherwise introduce harmful substances or fraudulent goods into the market.

This regulation implements the Freedom of Information Act (FOIA) for the Joint Board for the Enrollment of Actuaries. It describes how the public may access the Board's records, defines terms like 'records of the Joint Board' and 'unusual circumstances,' sets fees, establishes response timelines, and provides an appeals process.

Deletion would impair the public's ability to obtain information about a federal agency that regulates actuaries, reducing transparency and accountability. The regulation provides essential, predictable procedures that prevent arbitrary handling of requests and ensure consistent application of FOIA, which would be difficult to achieve without codified rules.

Regulation establishing standards for enrollment, certification, and continuing education of actuaries performing pension services under ERISA, including definitions, eligibility requirements, and professional development mandates.

Creates unnecessary bureaucratic barriers to entry in actuarial profession; market competition and professional organizations can ensure quality without federal licensing requirements that raise costs and reduce supply of qualified actuaries.

Establishes procedures for temporary employment of nonimmigrant foreign workers (H-2B) to ensure U.S. workers are available and not adversely affected, requiring labor certification to verify no qualified U.S. workers exist for temporary positions and that foreign workers won't depress wages or working conditions of domestic workers.

Creates costly bureaucratic barriers to legal immigration that distort labor markets, protect incumbent workers through artificial scarcity, and impose $2+ trillion in compliance costs while failing to address actual labor shortages. The certification process serves special interests rather than free market principles of voluntary exchange.

Federal Disaster Unemployment Assistance (DUA) provides unemployment benefits to workers and self-employed individuals whose unemployment is caused by major disasters, administered through state agencies with federal oversight and uniform interpretation rules.

Creates a permanent federal unemployment insurance program that expands federal control over labor markets, distorts incentives for disaster preparedness, and imposes significant compliance costs on states while undermining federalism by federalizing what should be state-level disaster response.

This regulation establishes procedures for the U.S. International Trade Commission to conduct investigations regarding trade matters, including duty modifications, duty-free treatment eligibility, trade agreement impacts, and retaliatory trade restrictions. The Commission provides advice to the President on economic effects and industry impacts of trade-related decisions.

Trade policy should be decided by elected officials, not bureaucratic commissions. This regulation creates an unelected layer of economic analysis that adds compliance costs and delays without improving outcomes. Market participants can better assess trade impacts than government agencies, and the Constitution gives trade power to Congress and the President, not specialized commissions.

This regulation establishes the administrative framework for U.S. Customs and Border Protection operations, including definitions of key terms, designation of ports of entry and service ports, business hours, the Customs seal, identification cards, test program procedures, and the structure of Centers of Excellence and Expertise. It sets forth rules about delegation of authority, vessel entry procedures at Customs stations, and the process for importers to appeal their assignment to specific Centers.

Without these procedural rules, customs operations would lack transparency, predictability, and clear boundaries. Importers and the public would face uncertainty about where and when customs services are available, how the agency is organized, and how decisions are made. The appeals process and testing provisions provide accountability and a path for improvement. While the underlying customs laws themselves may warrant scrutiny, the administrative framework necessary to implement any border enforcement must exist in published form to prevent arbitrary agency action and ensure rule of law.