Kleinfeld, Kaplan & Becker

What Kleinfeld, Kaplan & Becker does

Kleinfeld, Kaplan & Becker LLP (KKB) is a Washington, D.C.-based boutique law firm founded in 1967 that specializes in FDA law and advertising law. The firm traces its institutional roots to Vincent A. Kleinfeld, one of the first private practitioners of food and drug law, whose government service began in 1935 and included roles at the U.S. Department of Justice and as chief counsel of the Delaney Committee. KKB operates from a single headquarters at 1850 M Street NW and serves manufacturers, importers, distributors, and retailers of FDA-regulated products, including companies in pharmaceuticals, biologics, medical devices, cosmetics, dietary supplements, tobacco and nicotine, food and beverages, animal food and drugs, and consumer products. Its client base also includes private equity firms conducting regulatory due diligence and healthcare institutions seeking compliance guidance.

KKB delivers services across 14 practice areas covering the full product lifecycle: regulatory compliance, FDA approval pathways (510(k), PMA, De Novo, PMTAs), advertising claims substantiation and NAD defense, enforcement representation before FDA, FTC, USDA, DEA, and CPSC, transactions and due diligence, FDA imports and exports, pricing and reimbursement (including 340B), and cannabis. The firm is differentiated by the depth of former-government experience on its bench: multiple partners previously served in the FDA Office of Chief Counsel, USDA, DEA, and federal courts, and ten attorneys were recognized in the 2026 Best Lawyers in America and Ones to Watch editions.

The firm generates revenue through professional service fees (hourly rates, fixed fees, and retainers) typical of law firms. Go-to-market is enterprise-focused, relying on industry reputation, professional networks, conference participation (notably FDLI), and thought leadership (publications, blog content dating to 2015, FDLI book chapters). KKB holds no external funding, has no parent company, and has not engaged in mergers or acquisitions; it is partner-owned and independently managed. There are no disclosed technology products, APIs, or AI/ML capabilities; service delivery is human-capital-intensive and centered on regulatory expertise.

Name

Kleinfeld, Kaplan & Becker

Legal name

Kleinfeld, Kaplan & Becker, LLP

Website

https://kkblaw.com

Company type

Private

Founded year

1967

Operating status

Operating

Headcount range

11–50 employees

Short description

Kleinfeld, Kaplan & Becker is a Washington, D.C. boutique law firm founded in 1967 that provides FDA and advertising regulatory counsel to manufacturers, importers, distributors, private equity firms, and healthcare institutions across pharmaceuticals, medical devices, food, cosmetics, and tobacco.

Ownership category

akta.pro rank

Product category

FDA Regulatory Law Services

NAICS

Offices of Lawyers (54111), Offices of Lawyers (541110)

SIC

Services-Legal Services (8111)

akta.pro primary industry

Drug Regulators (Human Pharmaceuticals) (HLAJADAA)

akta.pro secondary industries

Controlled Substances & Pharmacy Regulation Authorities (HLAJACAI), Tobacco & Nicotine Contract Manufacturing & Private Label (CRADAJAM), Generic ANDA/Regulatory Affairs & Submissions (HLAIABAJ)

Keywords

• FDA regulatory law
• Drug and biologics compliance
• Medical device regulation
• Food and drug advertising
• FDA enforcement defense

Headquarters

HQ city

Washington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Legal Services Fees: KKB generates revenue through legal fees for regulatory counsel, administrative law practice, litigation, and compliance advisory services. The firm represents manufacturers, importers, distributors, and retailers of FDA-regulated products before agencies including FDA, FTC, USDA, DEA, and state authorities. Fee structures likely include hourly rates, fixed fees for specific matters, and retainers typical of law firm arrangements.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Kleinfeld, Kaplan & Becker is a specialized FDA law firm offering comprehensive legal services across 14 distinct practice areas covering FDA-regulated industries including food, drugs, biologics, medical devices, cosmetics, dietary supplements, tobacco, consumer products, and cannabis. The firm provides legal counsel on regulatory compliance, enforcement defense, advertising, transactions and due diligence, and government affairs for manufacturers, importers, distributors, and retailers of FDA-regulated products.

Product overview

Kleinfeld, Kaplan & Becker LLP is a specialized FDA law firm offering comprehensive legal services across 14 distinct practice areas covering FDA-regulated industries including food, drugs, biologics, medical devices, cosmetics, dietary supplements, tobacco, consumer products, and cannabis. The firm provides legal counsel on regulatory compliance, enforcement defense, advertising, transactions and due diligence, and government affairs. The practice areas function as integrated service modules that collectively address the full lifecycle of FDA-regulated products from market entry through compliance and enforcement matters.

Differentiator

Problem solved

Functional benefit

Products and services

• Food & Beverages Legal Services

Quantifiable outcome

• Consistently ranked among Best Law Firms for FDA Law and Advertising Law (2010-2024)
• +1 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

One partnership is on record.

• Vicente LLPcoreStrategic or Co-development Partner · 12 December 2025KKB collaborates with Vicente LLP, a premier cannabis and psychedelics law firm, on matters involving federal reclassification of cannabis to Schedule III. Attorneys Will Woodlee and Helen Ryan from KKB work with Vicente LLP colleagues to examine impacts on the cannabis industry's distribution and dispensing of botanical cannabis. The collaboration provides KKB clients with regulatory analysis on what reclassification would or would not change for the cannabis industry.

Scale indicators2 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Morgan, Lewis & Bockius LLP: Large AmLaw firm with a significant FDA and healthcare regulatory practice that overlaps with KKB on drug/biologic/device compliance and enforcement matters. Strong generalist incumbent competing for the same regulated clients.
• King & Spalding LLP: Has built a sizable healthcare regulatory and FDA practice, including tobacco/nicotine and product litigation. Larger and more diversified than KKB but increasingly overlapping on regulated-industry matters.
• Wiley Rein LLP: Washington, D.C.-based law firm with a prominent FDA and regulated-products practice (drugs, biologics, medical devices, tobacco, cosmetics). Mid-sized regulatory competitor with overlapping practice areas and similar DC-centric positioning.
• Epstein Becker & Green, P.C. National law firm focused on healthcare and life sciences, with active FDA/regulatory capabilities and medical device emphasis. Directly comparable in regulated life sciences focus but with broader employment/healthcare reimbursement footprint.
• Hogan Lovells US LLP: Global law firm with a market-leading FDA and life sciences practice spanning drugs, biologics, medical devices, food, and tobacco. Competes with KKB for premium FDA matters but operates at much greater scale and with international reach.
• Sidley Austin LLP: Large international firm with a strong FDA and healthcare regulatory practice covering drug, biologics, and device work — directly comparable service offering to KKB but bundled within a much broader corporate/litigation platform.
• Covington & Burling LLP: Major AmLaw firm with one of the deepest FDA/healthcare regulatory practices, overlapping directly with KKB's core drug/biologics/device, food, and tobacco work. Functions as a broad incumbent competitor and potential co-counsel on enterprise matters beyond KKB's scale.
• Arnold & Porter Kaye Scholer LLP: Washington, D.C.-anchored AmLaw firm with long-established life sciences/FDA practice. Competes with KKB on the FDA regulatory and product-liability aspects of regulated consumer products and pharmaceuticals.

Direct peers

• Hyman, Phelps & McNamara, P.C. Premier Washington, D.C.-based FDA regulatory boutique. Closest direct comparable to KKB by size, niche focus on FDA law across drugs, biologics, medical devices, food, and tobacco, and use of former-agency attorneys — competes head-to-head for specialty FDA matters.
• Keller and Heckman LLP: Long-standing Washington, D.C. FDA/regulatory boutique with parallel practice in food and drug law, advertising, tobacco, and product safety. Comparable to KKB in niche specialization and reliance on regulatory expertise, though historically somewhat larger and more diverse into TSCA/EHS matters.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/kkblaw

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Kleinfeld, Kaplan & Becker