Browse regulations

Requires FDA licensing (Form FDA 3448) and annual renewal for animal feed mills manufacturing medicated feed, with certifications of good manufacturing practices, labeling, and recordkeeping. The FDA can deny, suspend, or revoke licenses for safety violations, with a hearing process.

Compliance imposes significant costs on businesses, particularly small feed mills, raising barriers to entry and protecting incumbents. The licensing regime exemplifies regulatory capture, centralizing authority that states could better handle. Unseen effects include reduced competition, higher feed prices for farmers, and stifled innovation, ultimately harming the very animals and consumers it purports to protect.

FDA regulation establishing safety and effectiveness standards for over-the-counter sunscreen drug products, including permitted active ingredients, SPF testing requirements, labeling rules, and water resistance claims.

Sunscreen prevents skin cancer and burns - a proven public health benefit. The regulation ensures products actually work as claimed through standardized testing and prevents misleading SPF claims that could harm consumers.

Regulation governing safety and effectiveness evaluation of diagnostic radiopharmaceuticals, establishing clinical testing standards and radiation safety protocols for medical imaging agents.

Medical imaging agents require standardized safety assessment to prevent radiation exposure risks and ensure diagnostic accuracy. Without these standards, patients face potential harm from inadequate testing of radioactive substances.

This regulation establishes a list of bulk drug substances permitted for compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act, along with criteria for evaluating substances and warnings about safety/efficacy claims.

This regulation restricts compounding pharmacies' ability to customize medications, creating barriers to patient access for specialized treatments while imposing compliance costs on small pharmacies. The safety warnings are redundant given existing FDA authority and create unnecessary liability concerns that discourage legitimate compounding practices.

Regulates wholesale distribution, reimportation, and sample distribution of prescription drugs. Requires authorized distributor relationships, prohibits resale of hospital-purchased drugs, restricts reimportation to manufacturers only, and imposes extensive tracking/recordkeeping requirements for drug samples to prevent diversion.

Creates artificial barriers to entry protecting incumbent manufacturers from competition, prohibits legitimate secondary markets and reimportation that would lower drug prices, and imposes crushing compliance costs that fall disproportionately on small businesses. Federal control over drug distribution violates Tenth Amendment principles; market-based reputation systems and liability rules would ensure supply chain integrity more efficiently.

TVA FOIA regulations establish procedures for public access to TVA records, including request submission, processing tracks, fee structures, exemptions, and appeal rights under the Freedom of Information Act.

Americans would be worse off without FOIA access to TVA records, as this regulation ensures transparency in a federally-owned utility that controls critical infrastructure affecting millions of citizens.

Securities Exchange Act of 1934 forms and reporting requirements for broker-dealers, issuers, and institutional investors

Federal securities regulation exceeds constitutional authority and creates unnecessary compliance costs that distort markets. State-level oversight and private certification would better serve investors while reducing the $2 trillion regulatory burden.

16 CFR 1513 imposes detailed federal safety standards on bunk beds (guardrails, end structures, labeling) to prevent child entrapment, preempting state law and mandating specific technical specifications.

This federal mandate imposes $15-40+ per unit compliance costs that fall hardest on small manufacturers, reducing competition and innovation. It federalizes product safety, eroding Tenth Amendment federalism, and substitutes bureaucratic design specifications for parental judgment and market-based safety signals. Unseen costs include higher prices, reduced consumer choice, regulatory capture risks, and a precedent for expanding federal control over ordinary consumer goods. The voluntary standard, tort liability, and consumer education suffice without undermining liberty and free enterprise.

Federal bunk bed safety standard mandating specific guardrail designs, opening restrictions, labeling, and testing to prevent child entrapment deaths, applicable to all bunk beds manufactured/imported after June 19, 2000 except institutional use.

Imposes $15-40+ compliance cost per bed as hidden tax, disproportionately crushes small manufacturers and startups, reduces competition and innovation, substitutes federal for parental responsibility, and exceeds constitutional authority over local matters better handled by tort law, state regulation, and voluntary standards despite ~6 annual entrapment deaths.

Federal safety standard requiring multi-purpose lighters to be child-resistant, preventing successful operation by at least 85% of children aged 42-51 months through prescribed testing protocols involving 100-200 children. Applies to all such lighters manufactured or imported after December 22, 2000.

Federal regulation of consumer product safety exceeds constitutional authority under the Tenth Amendment; should be handled by states or through market forces. Compliance imposes significant testing burdens using child subjects, creates barriers to entry for small manufacturers, and substitutes centralized design mandates for parental responsibility and product liability incentives. The unseen costs—reduced innovation, diverted resources, and federal overreach—outweigh the marginal safety benefits achievable through voluntary standards or state oversight.

FTC interpretive regulation defining 'consumer commodities' under the Fair Packaging and Labeling Act, clarifying manufacturer/packager relationships, net quantity declaration rules, and retail price representation requirements.

Imposes disproportionate compliance costs on small businesses for information that markets can provide through private standards, brand reputation, and tort law. Creates barriers to entry, stifles packaging innovation, and centralizes labeling authority that should be determined by consumer choice and state-level competition.

The regulation implements a tariff-rate quota for sugar-containing products from the Uruguay Round Agreements, requiring export certificates from allocated countries for importers to claim in-quota duty rates.

Keeping this protectionist trade restriction imposes massive hidden costs: consumers pay inflated sugar prices, small food manufacturers face higher input costs, and the administrative burden of certificates and quotas wastes resources. The regulation perpetuates market distortions, protects inefficient domestic producers, and violates the principle that trade should be free from government interference. These unseen costs far exceed any theoretical benefits to a small special interest.

Implements U.S. obligations under the Chemical Weapons Convention by requiring exporters to provide advance notification (45 days prior, except 3 days for tiny saxitoxin shipments) and annual reports for Schedule 1 chemical exports to other State Parties, and to obtain foreign government End-Use Certificates for Schedule 3 chemical exports to non-State Parties, in addition to existing EAR/ITAR licensing.

Redundant reporting imposes significant compliance costs and 45-day delays on legitimate commercial transactions without enhancing national security; BIS could generate required OPCW data from existing licensing databases, avoiding extra burden on exporters and preserving competitiveness.

The FAA licenses reentry sites for spacecraft return operations, evaluating proposals to ensure they don't jeopardize public health/safety, property, national security, foreign policy, or international obligations. Licenses authorize site operations within specified parameters and require NEPA environmental compliance, including assessments or categorical exclusions.

Americans would be worse off without federal oversight because reentry debris can fall across state lines—creating cross-border hazards that states cannot regulate alone. The federal government must coordinate safety, enforce national security restrictions, and uphold international treaty obligations. Private liability and state regulations would be insufficient to prevent catastrophic harm from unlicensed operations, nor could they ensure uniform standards for footprint containment and site management.

FAA regulations governing launch site licensing, safety standards, environmental compliance, and operational requirements for commercial space launch facilities, including debris risk assessment, flight corridor definitions, and public safety protocols.

Space launch operations involve catastrophic failure risks that could kill civilians and destroy property. These regulations establish science-based safety standards, debris risk limits, and emergency protocols that protect public safety while enabling commercial space industry growth. Without them, launch sites would operate without standardized safety measures, potentially causing mass casualties from rocket failures.