Mr. Carvajal provides FDA and FTC regulatory counseling and litigation support to manufacturers and marketers of foods (including dietary supplements and medical foods), cosmetics, and OTC drugs. He has substantial experience with all food and dietary supplement issues, including recalls, Reportable Food Registry issues, and GMP and HACCP compliance issues. He also has substantial experience with labeling and advertising issues, including those that arise from the use of health, nutrient content, structure/function, and disease claims. Mr. Carvajal counsels product developers on regulatory strategy, including requirements pertaining to self-determinations of GRAS status and determinations of new dietary ingredient status. He also serves on due diligence review teams for major acquisitions and initial public offerings, and provides expert opinions on FDA regulatory matters. He has particular expertise in the regulation of products derived through biotechnology and nanotechnology.
From 2002 to 2007, Mr. Carvajal served as Associate Chief Counsel in FDA's Office of Chief Counsel, where his work was recognized with several individual and team awards. He currently serves on the Editorial Advisory Board for the Food and Drug Law Institute Monographs, and served as Chair of the Public Policy Outreach and Implementation Task Force of the Institute of Food Technologists.
Mr. Carvajal holds a J.D. from Northwestern University School of Law and an M.S. in Biology from the University of Michigan. He is admitted to practice in the District of Columbia.
Articles / Publications
Real-World Implications of United States v. Caronia, January 31, 2013
HP&M Files Comments on Draft NDI Guidance; Request Withdrawal and Reissuance Reflecting DSHEA Intent, December 2011
On FDA And Food Ingredient Safety: Is The "Gras" Henhouse At Risk?, December 3, 2010
The Cost of Inadequate Substantiation, November 5, 2010
Publish and Perish: A Disturbing Trend in the European Union's Regulation of Nutrition Health Claims Made on Foods, September / October 2010
Retailers on the Radar of FDA Under the Family Smoking Prevention and Tobacco Control Act, November/December 2009
The Family Smoking Prevention and Tobacco Control Act: An Overview, December 2009
Seeing Red Over "Green" - The Fight Over "Organic", "Natural", and "Sustainable", May 2009
Dermatologic Therapy, May 9, 2009
FDA'S Implementation of FDAAA'S Food-Related Provisions: A Work in Progress, January 2009
Surprise!...That Food Is Now a Drug, October 2008
What is Natural?, September 2008
Dietary Supplement GMPs: Legal Perspectives, September 2008
Food Allergens: Legal Requirements, September 2008
Cosmetics Labeling and Process for Assigning INCI Names, July 2008
FDA Nutrition Labeling Requirements, July 2008
Voluntary Labeling Claims, July 2008
The Battle Over rbST Labeling Comes to a Draw. Next Up, Animal Clones, May 2008
FDAAA § 912 - A Fundamental Shift in the Dividing Line Between Foods and Drugs, April 2008
As Nanotech Goes to Market, What Lessons Can We Draw From Biotech?, April 2008
FDA Regulation of Nanotechnology: What Are the Rules of the Road?, February 2008
Food, Dietary Supplements, and Cosmetics, December 2007
Blog Posts
FDA Releases Third Annual Report on the Reportable Food Registry, May 6, 2013
FDA Held In Violation of APA for Delay in Issuing FSMA Regulations, April 24, 2013
FDA Reportedly Extends Comment Period on FSMA Rules; Comments Requested on Facility Registration CPG, April 22, 2013
When is a Website Considered Labeling?, April 16, 2013
Food Traceability: Recordkeeping Without Regard to Risk?, April 9, 2013
FSMA Preventive Controls and OMB: No Cloak or Dagger, April 2, 2013
FDA Declines to Lower its Action Level for Mercury in Fish, March 10, 2013
Prelude to a Mandatory Food Recall - and Suspension of Registration?, March 5, 2013
The Hammer Falls on PCA; Indictment Could Raise Difficult Questions About Supplier Verification Under FSMA, February 25, 2013
FDA Consent Decree Calls for Retention of Food Labeling Expert, February 8, 2013
FDA Announces FSMA Tour, January 31, 2013
Citizen Petition Asks FDA to Restrict Availability of St. John's Wort, January 28, 2013
On FSMA's Second Anniversary, FDA Releases Two Major Proposed Rules, January 6, 2013
Are Food Allergen Thresholds on the (Far) Horizon?, December 27, 2012
In a Milestone for Regulation of Imported Foods, New Zealand and U.S. Food Safety Systems are Deemed Comparable, December 18, 2012
In Litigation, FDA Explains and Defends FSMA Efforts, December 11, 2012
In a FSMA First, FDA Suspends a Food Facility's Registration, November 29, 2012
CSPI Jacks Up Scrutiny of Caffeination and Fortification, November 19, 2012
The Toxin in Ackee: Naturally Occurring? Added? Does It Matter?, November 13, 2012
Expedited Entry of Imported Foods Remains a Gleam in Importers' Eyes, November 4, 2012
California Proposition 37's Take On "Natural", October 23, 2012
FDA Petitions D.C. Circuit for Rehearing on Cigarette Graphic Warnings, October 12, 2012
HHS OIG Reports Take Aim At Weight Loss and Immune Support Dietary Supplements, October 3, 2012
Suit Targeting Benecol Dismissed on Preemption Grounds, September 24, 2012
In Florida, Watch How You Use "Honey", September 17, 2012
Hold the Fructose: FDA Petitioned to Act Against Certain High Fructose Corn Syrups, September 5, 2012
FDA and OMB Sued Over Delays in FSMA Implementation, August 31, 2012
D.C. Circuit Affirms District Court Decision Striking Down FDA Regulation Requiring Graphic Warnings on Cigarette Packages, August 28, 2012
The Clock Ticks Away on AAFCO's Ingredient Definition Process, August 22, 2012
"Natural" Claims and Consumer Expectation, August 3, 2012
March Away From BPA Continues, July 19, 2012
Can Food Be Too Safe?, July 4, 2012
It's Official - FDA States Intention to Exercise Enforcement Discretion for Key FSMA Provisions, July 2, 2012
Food Additive Petition Seeks to Reduce Neural Tube Defects Among Hispanics, June 19, 2012
A Sweet Day for Sugar, June 1, 2012
FDA Speaks to Nanotech in Cosmetics, Foods, and Drugs, May 14, 2012
FSMA and the OMB, May 6, 2012
FDA Publishes Second Annual Reportable Food Registry Report, April 23, 2012
USP, Food Fraud, and FSMA, April 16, 2012
Warning Letters Begin Addressing FSMA Reinspection Fees, April 9, 2012
Where There's Smoke, There's Guidance: FDA Issues Two Draft Guidance Documents for Tobacco Products, April 2, 2012
6th Circuit Largely Affirms District Court Ruling on Constitutionality of the Tobacco Act, March 22, 2012
NTP Director Turns Spotlight on Endocrine Disruptors, March 19, 2012
FDA's Qualified Health Claim For Green Tea and Breast/Prostate Cancer Found Unconstitutional, March 14, 2012
Is Yours A High-Risk Food Facility? Now You Know, March 12, 2012
Breathable Food Draws FDA Warning Letter, March 7, 2012
D.C. District Court Strikes Down FDA Regulation Requiring Graphic Warnings on Cigarette Packages, March 2, 2012
Engineered Nanoparticles Reported to Affect Iron Absorption, February 27, 2012
"Breathable Food" Comes Under Scrutiny, February 21, 2012
Quality Encompasses Safety (At Least If You're an Almond), February 12, 2012
Congressional Representatives Press FDA For Action on Third-Party Audits, January 22, 2012
FDA Sued For Not Acting on Nanotech Citizen Petition, December 29, 2011
State Food Facility Inspectors and Third-Party Auditors Face Increased Scrutiny, December 26, 2011
Court Finds That Lane Labs' Advertising Claim Lacks Substantiation, December 14, 2011
Dietary Supplement GMPs: Repeat Offenders Beware, December 5, 2011
When "All Natural" Isn't, December 1, 2011
In Sugar v. HFCS (aka "Corn Sugar"), A Message For Trade Association Members, November 20, 2011
FDA Highlights Compliance Efforts Against Tobacco Product Retailers, November 13, 2011
Nanotech Roundup: Foods v. Drugs, the EC Definition, and NNI's EHS Research Strategy, October 30, 2011
FDA Updates Guidance on Administrative Detention of Food, October 27, 2011
7th Circuit Affirms Dismissal of Fiber Case, With Prejudice, Largely On Preemption Grounds, October 24, 2011
In a First, FDA Seizes Administratively Detained Food, October 13, 2011
Pathways to Market for New Tobacco Products Begin to Take Shape, October 5, 2011
Regulatory Science vs. Talk Show Science, October 4, 2011
A Very Full Plate: FDA's 5-Year Plan for Foods, October 2, 2011
Court Sides With Government in Case Alleging Adulteration, But Deems Injunction Request Overbroad, September 15, 2011
FDA and FSIS Request Information on Sodium Reduction, September 14, 2011
Is a Bioengineered Food "100% Natural"?, September 11, 2011
FDA Requests Nominations for TPSAC Voting Members, September 2, 2011
NRDC Doggedly Pursues Action on BPA, August 29, 2011
Del Monte Fresh Sues FDA to Invalidate Cantaloupe Import Alert, August 23, 2011
FTC: Sales, Advertising, and Promotion Decline for Cigarettes, Increase for Smokeless Tobacco, August 2, 2011
Domestic Food Facilities, U.S. Agents, and Importers: Get Ready for FSMA Fees, July 31, 2011
2 = 2, Unless the 2 are in "ONE A DAY", July 28, 2011
Can Efforts to Develop an Integrated Food Safety System Advance in the Face of State Budget Crises?, July 19, 2011
FDA's NDI Guidance and the 18-Year Cycle of Correcting Regulatory Overreach, July 14, 2011
Industry Front-of-Pack Labeling and "Bad Foods" Come Under Added Scrutiny, June 26, 2011
DC Circuit Rules that FDA Inaction on Requested BPA Ban Should be Challenged in District Court, June 21, 2011
Tentatively, FDA Hones In On A Working Definition of Nanotechnology, June 19, 2011
FDA Issues Letter of Enforcement Discretion for Qualified Health Claims for Infant Formula, May 31, 2011
Farmer Allegedly Harmed by FDA Warning on Tomatoes Sues Under the Federal Tort Claims Act, May 26, 2011
Please Pass the Prune Juice: Must FTC Toe FDA's Line on Health Claims?, May 25, 2011
GAO Issues Critical Seafood Safety Report (and Domestic Catfish Farmers Rejoice), May 19, 2011
FSMA Update: FDA Publishes Interim Final Rules to Amend its Administrative Detention and Prior Notice Regulations, May 4, 2011
At the Atlantic Food Summit, Talk of Sustainability, Security, Nutrition Policy - and FDA Priorities, April 26, 2011
Food Safety Crime Bill Clears Senate, April 21, 2011
A Useful Resource on the Food Safety Modernization Act (and the Price is Right), April 7, 2011
Rep. Waxman Presses FDA for Action on Flavored Cigars, April 6, 2011
Challenges of Implementing FSMA Import Provisions Take Shape, March 29, 2011
Adverse Event Reports Might or Might Not be Material Information to Investors, March 23, 2011
FDA Publishes Q&A on Radiation Safety, Issues Import Alert, March 23, 2011
FDA Begins Implementing the Food Safety Modernization Act's Import Safety Provisions, March 10, 2011
FDA Determines Homotaurine is Not a Dietary Ingredient, Punts on Applicability of Its Rulemaking Authority Under FDC Act §§ 201(ff)(3)(B) and 301(ll), February 24, 2011
Sen. Leahy Asks DOJ for Update on Investigation of Peanut Corporation of America, February 23, 2011
FDA Sued Over E-Cigarettes - Again, February 18, 2011
Enhanced Criminal Penalties for Food Safety Violators?, February 1, 2011
Salmonella and Undeclared Allergens Get Starring Roles in FDA s First Reportable Food Registry Annual Report, January 24, 2011
GAO Recommends that FDA Tighten its Grip on Structure/Function Claims in Food Labeling, January 23, 2011
Are Dietary Ingredient Facilities Subject to Mandatory HACCP Requirements?, January 13, 2011
With New Food Safety Law, Significant Burdens on Industry (and on FDA), January 5, 2011
A Holiday Present to the Human and Animal Food Industries: FDA Reopens Comment Period on 1997 GRAS Notice Proposed Rule, January 4, 2011
With the Food Safety Modernization Act Set to Become Law, Certain Provisions Will Take Immediate Effect, December 23, 2010
Surprise, Surprise... Food Safety Legislation Roars Back to Life, December 20, 2010
Food Safety Legislation on Life Support, December 17, 2010
FTC and Dannon Settle Over Probiotic Claims, December 16, 2010
Would You like a Parenting Class with that Happy Meal?, December 16, 2010
Yes, e-cigarettes are Tobacco Products (Not Drugs/Devices), December 9, 2010
FDA Publishes Annual Guidance Agenda, December 8, 2010
Federal Judge Orders that Genetically Modified Sugar Beet Seedlings be Pulled from the Ground, December 6, 2010
Food Safety Legislation Hits a Roadblock, December 2, 2010
Color Warnings on Hyperactivity Coming to a Food Near You?, December 1, 2010
U.S. Senate Advances Food Safety Legislation, November 30, 2010
FDA and FTC Target Caffeinated Alcoholic Malt Beverages, November 23, 2010
FDA Proposes Graphic Cigarette Warning Labels, November 10, 2010
Trans Fat Labeling: Another Court Finds in Favor of Preemption, November 8, 2010
IOM Charts Narrow Course for FOP Labeling, October 21, 2010
FDA and FTC Continue Joint Actions Against Dietary Supplements, October 13, 2010
Of Fish, Milk, and Beets: Biotech Heats Up (Again), October 4, 2010
FDA Releases Draft Guidance on Acidified Food, September 30, 2010
Fiber Case Gets Flushed, September 15, 2010
FDA Continues Clamp-down on Antioxidant Claims, September 9, 2010
U.S. Supreme Court to Rule on When is an AER material Information that Must be Disclosed to Investors, September 8, 2010
HHS Seeks Input on Potential Benefits and Risks of Synthetic Biology, August 31, 2010
Judges Ask FDA: What is "Natural"?, August 26, 2010
FDA Seeks Information on Safety and Effectiveness of Nanodevices, August 23, 2010
Senate HELP Committee Moves on Food Safety Legislation, August 13, 2010
In FDA's RFR Report, Some Intriguing Numbers, July 29, 2010
Smaller Retail Food Establishments Get Chance to Pick Their Poison, July 26, 2010
Supreme Court Decision on Bioengineered Alfalfa Stirs Action on the Hill, July 1, 2010
FDA's Implementation of the Family Smoking Prevention and Tobacco Control Act Picks Up Steam, June 10, 2010
CVM's GRAS Notification Program is Up and Running, June 6, 2010
Snap, Crackle & Pop is OK, but FTC Rules Immunity Claims Off Limits, June 3, 2010
Alliance for Natural Health Scores First Amendment Victory on Qualified Health Claims, June 1, 2010
New Legislation Targets Full Implementation of DSHEA, May 27, 2010
FDA Revises its Reportable Food Registry Guidance, May 26, 2010
FTC Moves to Compel Companies to Submit Information on Marketing of Foods to Children, May 25, 2010
FDA Announces Availability of New Electronic Portal for Reportable Food Registry Reports, Among Others, May 24, 2010
FDA's Regulation of Nanotech: a Change in the Wind?, May 19, 2010
FDA Posts its First Dietary Supplement GMP Warning Letter, May 10, 2010
Smaller Cigarette Manufacturers Challenge Constitutionality of FDA's Restriction on Certain Product Names, April 29, 2010
OIG Calls for Increased FDA Food Inspections and Expanded Penalties, April 8, 2010
In Health Care Reform, a Nod to the Role of Nutrition, March 29, 2010
FTC Confirms Targeting of Probiotics and Immunity Claims; CSPI Eggs on States and the Private Bar, March 14, 2010
GAO Report Criticizes FDA's Oversight of GRAS Substances (Including Nanomaterials) and Points to Potential Legislative Fixes, March 9, 2010
HVP - The Next Peanut Butter?, March 5, 2010
FTC Hones in on Omega-3 Claims, Among Others, February 17, 2010
Proposed Legislation Would Clamp Down on New Dietary Ingredients, February 11, 2010
FDA Lays Out Ambitious Agenda in the Latest Draft of its Framework of the Animal Feed Safety System, January 27, 2010
Senators Pryor and Cardin introduce the Nanotechnology Safety Act of 2010, January 24, 2010
FDA Seeks to "Strengthen its Oversight of BPA", January 19, 2010
Warning: This Meat Contains a Chemical Known to the State of California to Cause Cancer and Reproductive Toxicity, January 12, 2010
What is a Tobacco Product "Ingredient"?, November 3, 2009
Speaking Engagements
Food Safety Summit Expo and Conference, April 30 - May 2, 2013
Moderator and presenter for session titled "Impact of the US Food Safety Modernization Act on International Regulatory Policies and Trade"
FDLI Annual Conference, April 23 - 24, 2013
Moderator for breakout session titled "Dietary Supplements/Cosmetics/Food: Nanotechnology at a Crossroads"
Real-World Implications of United States v. Caronia, January 31, 2013
Food Chemical News Conference - The Impact of FSMA on Food Importing, December 4, 2012
Food Import and FSMA Preventive Controls
The Food, Drug & Cosmetic Division of the American Society for Quality 23rd West Coast Conference Dietary Supplement Global Strategies, September 14, 2012
Panel member for "Compliance Challenges" and "Enforcement Hot Topics"
Dietary Phosphorus Consensus Conference, June 26, 2012
Phosphorous Labeling in the U.S. - Regulatory Considerations
ABA Section of Litigation Food & Supplements Second Annual Workshop, June 12, 2012
Panel on "The Impact of the Food Safety Modernization Act on the Food Industry"
FDLI's Food Week Conference, January 23 - 26, 2012
Moderator for the Labeling and Advertising session
IFT Food Policy Impact Conference, December 1, 2011
Navigating Today's Labeling Requirements&And What's Coming Up
IFT Food Policy Impact: Short Course, November 29 - 30, 2011
Co-instructor: Labeling Requirements and Implications for Foods Marketed in the U.S.
ASQ Food, Drug, and Cosmetic Division's 22nd West Coast Conference on Dietary Supplement Challenges: cGMPs, Analytical, FSMA, NDI, and More, September 30, 2011
"Food Safety Modernization Act Implementation Update" and "New Dietary Ingredients"
ACI Food Safety Regulatory Compliance Summit, June 15 - 16, 2011
The Reportable Food Registry One Year Later: Best Practices for Reporting Events While Minimizing Exposure to Government Investigation or Private Litigation
IFT Annual Meeting, June 11 - 14, 2011
- Nutrition Labeling Requirements for FDA
- Nutrition Labeling Requirements
- Nutrient Content, Structure/Function and Health Claims
- Other Claims: Production, Processing, and Marketing
- Create and Evaluate Your Own Food Label
- The Legal Aspects of Food Allergen Labeling and Control
ABA's First Annual Workshop on Food and Supplements, February 17, 2011
Co-moderator for the session on the impact of the Food Safety Modernization Act
FDLI Food Week, Introduction to Food Law and Regulation, January 24 - 27, 2011
Unintended Components/Contaminants of Food
Personal Care Products Council Webinar, December 2, 2010
Product Labeling, Assignment Processes and Global Harmonization of INCI Names
FDLI Enforcement and Litigation Conference, October 12 - 13, 2010
Food and Dietary Supplements Breakout Session.
IFT 2010 Annual Meeting and Food Expo, July 17 - 20, 2010
Labeling Requirements and Implications for Foods Marketed in the U.S. and Food Regulation: Evolutionary changes in revolutionary times
North American Millers' Association 2010 Division Meeting, March 2010
FDA Under the Obama Administration
Unither Nanomedical and Telemedical Technology Conference, February 23 - 26, 2010
Keynote Speaker
FDLI Introduction to Food Law and Regulation Annual Conference, January 26, 2010
Food Safety: Unintended Components/Contaminants of Food
Product Labeling and Process, November 19, 2009
Personal Care Products Council
American Society for Nanomedicine Inaugural Conference, October 24, 2009
FDA's Regulation of Nanotechnology: Current Controversies and Potential Impacts on Nanomedicine
NanoBiotech 2009, October 19, 2009
ACI FDA Boot Camp, September 16, 2009
Spotlight on Nanotechology
FDLI's Webinar Series on Issues and Implementation of the Food and Drug Administration Amendments Act of 2007, September 10, 2009
Reportable Food Registry
Thompson Publishing Webinar, August 25, 2009
Family Smoking Prevention and Tobacco Control Act
IFT Annual Meeting and Food Expo, June 5 - 9, 2009
Instructor on food labeling and presenter on GRAS determinations and the use of "natural" claims
FDA Fellows - Introduction to Food Law and Regulation, May 26 - 27, 2009
ACI Nanotechnology Law Webinar, May 19, 2009
The Essential Guide to the Legal & Regulatory Aspects of Nanotechnology
FDLI webinar: What is Natural?, April 8, 2009
Industry perspectives on the use of "natural" claims in the labeling of foods, including recent court cases and challenges brought before the National Advertising Division regarding advertisers' use of the claim. Also addressed was the question of whether "natural" claims are preempted under the FDCA. A recording of the webinar can be purchased here.
IFT FLDR mid-year meeting, April 3, 2009
FDA's implementation of the food-related provisions of the FDA Amendments Act of 2007 (namely the prohibition in FDCA section 301(ll) on the addition of "drugs" to food, and the requirement in section 417 that FDA institute a Reportable Food Registry)
Nanotechnology Workshop at the ACI FDA Boot Camp, March 31, 2009
An introduction to the science of nanotechnology, an overview of the National Nanotechnology Initiative, and a review of FDA's regulatory approach to products derived through nanotechnology.
ABA Audioconference: Hot Topics in Food Law II, February 10, 2009
Differences between FDA's regulation of contaminants and its regulation of unsafe food additives and an update of the controversy surrounding the use of bisphenol A in food contact articles.
FDLI Dietary Supplements Conference, January 29 - 30, 2009
Formulation and Review of Structure/Function Claims and Health Claims for Dietary Supplements Emerging Topics, which addressed section 301(ll) of the FDCA, regulation of dietary supplement/OTC combination products, and Proposition 65 issues. A recording of the conference presentations can be purchased here.
INCI Nomenclature Workshop for the Personal Care Products Council, October 20, 2008
IFT Webinar: What is Natural?, September 25, 2008
Food, Drug, & Cosmetic Division of the American Society for Quality 19th West Coast Conference, September 19, 2008
Dietary Supplements GMPs: Are We Ready? Legal Update
Personal Care Products Council Webinar, July 10, 2008
Product Labeling & Process for Assigning Ingredient Names
IFT Annual Meeting, June 27 - July 1, 2008
Co-instructor for the Food Labeling Short Course and organizer for the symposium and roundtable "What is Natural?"
NanoBioNexus Conference, April 10, 2008
Clearing the US and EU Regulatory Path to Product Approval - "What Similarities and Differences Exist and How Can Companies Manage the Hurdles?"
114th International Association of Operative Millers Conference & Expo, April 2010
The FDA's Direction and Management's Responsibility in Food Safety