Professional Experience
Mr. Wasserman’s practice is focused on matters involving the marketing of foods, dietary supplements, cosmetics, drugs, and medical devices. With extensive experience advising clients on the advertising and labeling of products such as these, which are subject to overlapping jurisdiction of the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), he helps his clients develop creative approaches to meeting marketing objectives while staying within the constraints of applicable regulatory frameworks. In addition to working with products regulated by the FDA, Mr. Wasserman has extensive experience advising clients on the regulation of consumer products by the Consumer Product Safety Commission (CPSC). FDA: As an FDA lawyer, Mr. Wasserman’s practice includes: - Advertising and labeling reviews
- Ingredient reviews and product formulation issues
- Responding to FDA warning letters
- Responding to import detentions and product seizures
- Adverse event reporting and product recalls
- Preparing 510(k) premarket notifications for medical devices
- Preparing New Dietary Ingredient (NDI) notifications for supplements
Advertising: Mr. Wasserman is an experienced advertising lawyer who regularly reviews advertising campaigns, including websites, for regulatory compliance. When additional data is necessary to support desired claims, Mr. Wasserman works with the company to develop the needed substantiation. In addition to federal and state agencies, his practice includes representing clients in proceedings before the National Advertising Division (NAD) of the Council of Better Business Bureaus (CBBB) and the Electronic Retailing Self-Regulation Program (ERSP). CPSC: Mr. Wasserman is an experienced CPSC lawyer who draws upon his strong background in consumer product safety issues to help clients comply with the CPSC’s labeling and reporting requirements. When corrective action is necessary, he helps clients conduct effective product recalls and minimize adverse publicity. Also, he is experienced in handling CPSC investigations into whether companies complied with the reporting requirements of Section 15(b) of the Consumer Product Safety Act (CPSA).
Education
The George Washington University Law School, J.D., 1993. Vassar College, B.A., 1989. |
Memberships & Activities
Member, Electronic Retailing Association. Member, International Consumer Product Health and Safety Organization. Member, Food and Drug Law Institute (FDLI); Member of the Food and Dietary Supplements Committee and Former Chairman, H. Thomas Austern Writing Awards Committee. Admitted to practice in the District of Columbia and Maryland. |
Honors & Awards
The Best Lawyers in America, 2007-2011. |
Publications
Quoted, “FTC Raises Claim Substantiation Bar for Dietary Supplements in Settlements,” The Tan Sheet, July 19, 2010. Quoted, “Wrigley to pay millions over misleading gum claims,” NutraIngredients-USA.com, July 7, 2010. Interviewed by Hank Schultz for podcast on “GAO report about tainted supplements,” Functional Ingredients, July 2, 2010. Quoted, “Despite FTC's 'Timid' Kellogg Action, Rigorous Claims Enforcement Expected,” The Tan Sheet, June 7, 2010. Interviewed, “FDA Steps Up Enforcement Under Obama Administration,” Nutrition Business Journal, June 1, 2010. Quoted, “FTC Regulations Change the Marketing Landscape,” Nutrition Business Journal, May 2010. Quoted, “U.S. regulators signal new era of health claims crackdowns,” New Nutrition Business, April 2010. Quoted, “Odds Are Stacked Against Matrixx in Bid to Rescind Zicam Warning Letter,” The Tan Sheet, March 15, 2010. Quoted, “Industry welcomes FDA claims crackdown,” NutraIngredients-USA.com, March 4, 2010. Quoted, “FDA Issues Warning on Food Labels,” Latimes.com, March 4, 2010. Quoted, “FDA Cracks Down on Misleading Food Package Labels,” Chicagotribune.com, March 3, 2010. Quoted, “FDA Insists H1N1 Warning Letters Stop False Claims,” NutraIngredients-USA.com, February 5, 2010. Quoted, “Matrixx Initiatives Files Suit Against FDA on Unanswered FOIA Grounds,” The Tan Sheet, February 1, 2010. Author, “2009 review: FDA warning letters clampdown,” NutraIngredients-USA.com, January 6, 2010. Author, “Message on a bottle: FDA’s draft guidance on liquid dietary supplements,” Functional Ingredients, December 11, 2009. Quoted, “FDA Supplement Beverage Guidance May Open Can of Regulatory Worms,” The Tan Sheet, December 10, 2009. Quoted, “Industry Calls for Greater DSHEA Enforcement, Not New Legislation,” NutritionBusinessJournal.com, October 8, 2009. Quoted, “How the FTC's New Testimonial Guidelines Will Impact Supplement Marketers,” NutritionBusinessJournal.com, October 6, 2009. Quoted, “FTC Testimonial Guide Moves Past ‘Results Not Typical,’ Enters Blog Era,” The Tan Sheet, October 6, 2009. Quoted, “FTC Issues Revised Guides on Use of Endorsements,” NutraIngredients-USA.com, October 6, 2009. Quoted, “FDA Reorganization Elevates Scientific and Food Safety Priorities,” The Tan Sheet, August 24, 2009. Quoted, “FDA Choice for Tobacco Chief Suggests Bigger Role for Cessation Programs,” The Tan Sheet, August 24, 2009. Quoted, “LaneLabs Harnesses Strong Science, Expert Support to Prevail Over FTC,” The Tan Sheet, August 24, 2009. Author, “FDA provides some answers on adverse reporting,” Functional Ingredients, August 11, 2009. Quoted, “Congress bills challenge FDA and FTC power,” NutraIngredients-USA.com, July 30, 2009. Quoted, “Are supplements with transmucosal delivery systems crossing the drug barrier?” Functional Ingredients, July 8, 2009. Interview, “Obama's FDA Takes More Aggressive Stance,” KCBS Radio, July 3, 2009. Quoted, “FDA Uses 'Unusual' Action to Get Matrixx’s Zicam off the Market,” The Tan Sheet, June 29, 2009. Quoted, “Zicam Case Shows FDA Takes Defining Adverse Events Seriously,” The Tan Sheet, June 22, 2009. Quoted, “FDA Letter Puts Health of Primary Zicam Brands in Doubt,” Advertising Age, June 18, 2009. Interviewed by KCBS Radio on “Intra-Nasal Product Warning: Zicam Recall,” June 16, 2009. Author, “FDA action against false H1N1 claims swift and substantial,” Functional Ingredients, June 16, 2009. Co-Author, “In Defense of DSHEA: A Call for Calm,” Nutraingredients-usa.com, May 22, 2009. Co-Author, “Selling Safely Online: Understanding Some of the Regulatory Pitfalls of Online Marketing,” Natural Products Marketplace, May 2009. Quoted, "Bayer Reboots Heart Advantage With Promotion for Aspirin," The Tan Sheet, June 8, 2009.
Quoted, “Supplements’ Direct Response Marketing Success Sets Off FTC Alarm,” The Tan Sheet, April 20, 2009.
Co-Author, “FDA Supplement Warning Letters: 2008 Year in Review,” Nutraingredients-usa.com, January 27, 2009. Quoted, “Merix Takes Road Less Traveled to Add Shingles Relief to OTC Monograph,” The Tan Sheet, January 5, 2009. Quoted, “Cancer Claims Continue Attracting Federal Enforcement Actions,” The Tan Sheet, September 22, 2008.
Quoted, “Enzyte Marketers’ Prison Time Could Scare Firms Off Fraudulent Claims,” The Tan Sheet, September 1, 2008.
Quoted, “Enzyte Marketers’ Prison Sentence Could Scare Firms Off Fraudulent Claims,” Health News Daily, August 28, 2008.
Quoted, “FDA Adds to Unapproved Drug Initiative Scorecard with Action Against KV,” The Pink Sheet, August 4, 2008.
Quoted, “Lawyers Question FDA’s Broad Brush Approach in Cancer Claims Crackdown,” The Tan Sheet, June 23, 2008.
Quoted, “HFCS ‘Natural’ Drink Not Deceptive, Rules Court,” Foodnavigator.com, June 19, 2008.
Quoted, “Placebo Supplement Spans Opposition,” Nutraingredients-usa.com, June 17, 2008. Quoted, “Placebo Causes Adverse Reaction with Industry, Raises Regulatory Concerns,” The Tan Sheet, June 2, 2008.
Quoted, “Reminder of FTC Attention to Supplement Ads: $120 Mil. Seasilver Judgment,” The Tan Sheet, May 5, 2008.
Quoted, “Competition Twists Line Between Marketing Drugs, Cosmetics – Attorney,” The Tan Sheet, April 21, 2008.
Quoted, “Attorney Discusses Cosmetic Trespasses on Drug Turf Leading to FDA Action,” The Rose Sheet, April 14, 2008.
Quoted, “Legal Advice to Avoid FDA/FTC Claim Clamp-Down,” Nutraingredients-usa.com, April 11, 2008. Quoted, “Unsubstantiated Claims Come in Many Forms, Create Minefield of Challenges,” The Tan Sheet, March 31, 2008.
Co-Author, “The Claim Game: Getting the Most Out of Your Label and Playing by the Rules,” Organic Processing Magazine, July-September 2007. Co-Author, “Much Ado About Natural,” Electronic Retailer, July 2007. “An Overview of the Challenges We Face and How to Survive Them,” Chapter in Inside the Minds: Food and Drug Law Settlements and Negotiations, 2006. “Homeo-What-Ic?” Electronic Retailer, August 2006. Co-Author, “How Selling the Fountain of Youth Can Get You in Hot Water,” Electronic Retailer, July 2005. Co-Author, “Substantiating Dietary Supplement Claims Guidance from the FDA,” Consumer Protection Update, Newsletter of the Consumer Protection Committee, ABA Section on Advertising Law, Spring 2005. Co-Author, “Corrective Advertising for Misleading DTC Advertisements: More to Come?” FDLI Update, November/December 2003. Co-Author, “R&D Management: The Wide World of Food Regulations,” Food Product Design, August 2003. Co-Author, “Substantiating Claims for Over-the-Counter Drugs at FTC: How Much Is Enough?” Pharmaceutical Law & Industry Report, Vol. 1, No. 14, April 18, 2003. “CPSC Civil Penalties: What They Don’t Know Can Hurt You,” Response, May 2002. |
Speaking Engagements
Speaker, "Dietary Supplements and Functional Foods: What You Need to Know About 2010 Enforcement," Thompson Interactive Audio Conference, August 26, 2010. Speaker, "Dietary Supplement Claims Compliance: Is the FDA Redefining the Supplement Standard," Elsevier Business Intelligence Webinars, June 23, 2010. Speaker, 2010 Functional Food and Beverage Web Seminar, April 1, 2010. Speaker, “Serious Adverse Event Reporting for OTCs and Dietary Supplements: Confusion Reigns and Labeling Enforcement Looms,” FDA News Virtual Conference, February 9, 2010. Speaker, “Dietary Supplement Enforcement 2010: What Pharma and Supplement Makers Must Prepare For,” Thompson Interactive Audio Conference, January 7, 2010. Speaker, “Live from D.C.: Its Make Your Claims Right!” Supply Expo 2010, March 13, 2010 Speaker, “The Claim is Right: Are You Smarter Than a Regulator,” Natural Products Expo East, September 24, 2009. Speaker, “Food Claims Enforcement and Litigation on the Rise: How to Reduce Your Risk,” Thompson Interactive Audio Conference, July 28, 2009. Speaker, “The B2C Claim Game: Health and Beauty Edition,” 2009 Electronic Retailing Association Conference, Las Vegas, NV, September 13, 2009. Speaker, “The Claim Is Right! (a.k.a. ‘Are You Smarter Than a Regulator?’)” Natural MarketPlace 2009, Las Vegas, NV, July 9, 2009. Speaker, “Over-the-Counter (OTC) Drugs,” FDLI Introduction to Drug Law and Regulation Conference, Washington, DC, June 26, 2009. Speaker, “Post-Approval Issues,” FDLI Introduction to Drug Law and Regulation Conference, Washington, DC, June 26, 2009.
Speaker, “Legal Issues of Direct Marketing,” Direct Marketing Association’s Consumer Direct Marketing Day, Santa Ana, CA, March 9, 2009. Speaker, “Are You Smarter Than a Regulator,” Natural Products Expo West, Anaheim, CA, March 7, 2009. Speaker, “What You Need to Know Now About Emerging Dietary Supplements Issues & Trends – Review of Recent Federal Trade Commission Enforcement Actions,” FDLI Conference, Washington, DC, January 29, 2009. Speaker, “How to Make Claims and Avoid the Shame,” Natural Products Expo East, Boston, MA, October 17, 2008. Speaker, “Natural, Organic and Green: Ensuring FDA and USDA Compliance When Eco-Labeling,” Thompson Interactive FDA & Environment Audio Conferences, September 17, 2008. Speaker, “Making the Right Choices in a Heavily Regulated Industry – How to Truthfully and Accurately Market Dietary Supplements,” Colorado Bar Association/CLE Advertising Law: FTC Rules of the Road 2008, Colorado, July 24, 2008. Speaker, “Introduction to Drug Law and Regulation: A Program on Understanding How the Drug Industry Is Regulated,” FDLI Conference, Washington, DC, June 26-27, 2008. Speaker, “Advertising Legal Challenges,” Personal Care Products Council – Legal and Regulatory Conference, Chicago, IL, May 9, 2008.
Speaker, “New Adverse Event Reporting for Dietary Supplements,” Drug, Chemical & Associated Technologies Nutrition & Health Forum, Palm Springs, CA, May 7, 2008.
Speaker, “Is It a Drug or Is It a Cosmetic?” 51st Annual FDLI & FDA Conference, Washington, DC, March 27, 2008.
Speaker, “Regulatory Seminar: Winning the Claim Game Without Landing in the Penalty Box,” Natural Products Expo West, Anaheim, CA, March 14, 2008. Moderator, “What Sparks an Investigation?” Consent Decrees, Criminal Cases, and Corporate Integrity Agreements, FDLI's 6th Annual Conference on Enforcement & Litigation, Washington, DC, February 19, 2008. Speaker, “New Serious Adverse Event Reporting for OTCs and Dietary Supplements: The FDA Expands Its Reach...Again.” FDAnews Audioconference, January 10, 2008. Speaker, Expert Roundtable: Dietary Supplements, 29th Annual Promotion Marketing Law Conference, Chicago, IL, November 16, 2007. Speaker, “Playing by the Rules: Making Meaningful Claims That Comply With Current Regulations,” Natural Products Expo East, Baltimore, MD, September 27, 2007. Speaker, “Dietary Supplement GMPs: Compliance Expert Demystifies FDA’s 1,300-Page Final Rule,” FDAnews Audioconference, September 11, 2007. Speaker, “Seeds of Confusion: Understanding FDA’s Regulation of Botanical Drugs Versus Dietary Supplements,” FDA Regulatory and Compliance Symposium: Managing Risks – From Pipeline to Patient, Harvard University, Cambridge, MA, August 23, 2007. Speaker, “Avoiding Unsubstantiated Claims in the Advertising and Marketing of Cosmetics and OTC Topicals,” American Conference Institute: Cosmetics, OTC Topical Drugs, Cosmeceuticals, & Nutracosmetics, New York, NY, May 21, 2007. Speaker, “Making Meaningful Health Claims in Risky Regulatory Waters,” Natural Products Expo West 2007, Anaheim, CA, March 9, 2007. Speaker, “510(k) v. PMA: Making the Right Choice for Your Corporate Strategy,” FDAnews Audioconference, January 25, 2007. Speaker, “Over-the-Counter (OTC) Drugs,” FDLI Introduction to Drug Law and Regulation, Washington, DC, November 7, 2006. Speaker, “Post-Approval Issues,” FDLI Introduction to Drug Law and Regulation, Washington, DC, November 7, 2006. In October 2006, The Tan Sheet featured an article summarizing his speech from Expo East 2006 on challenging your competitors’ claims (or defending your own). Speaker, “How to Navigate Your Claims in Risky Regulatory Waters,” Natural Products Expo East, Baltimore, MD, October 6, 2006. Panelist, “Weight Loss Panel,” FDLI 49th Annual Conference: Celebrating the Centennial of the 1906 Pure Food & Drug Act, Washington, DC, April 7, 2006. Speaker, “Understanding How FDA Regulates the Drug Industry,” Introduction to Drug Law and Regulation Workshop, Washington, DC, November 17, 2005. Speaker, “Manufacturing and Marketing Functional Foods and Nutraceuticals,” Canada Forum: Health and Wellness in the Food Industry, Toronto, Ontario, November 15, 2005. Speaker, “State of the Industry,” ExpoEast, Washington, DC, September 16-17, 2005. Speaker, “From Inception to Marketplace: A Practical Guide for Taking Your Product to Market,” ExpoWest 2005, Anaheim, CA, March 18, 2005. Speaker, International Consumer Product Health and Safety Organization’s 11th Annual Meeting and Training Symposium, Orlando, FL, March 2, 2004. Speaker, “Country of Origin Marketing and Labeling,” Food and Drug Law Institute’s FDA and Customs – From Cooperation to Partnership: How to Import FDA-Regulated Goods in Today’s Security-Focused Regulatory Environment, December 10, 2003. Mr. Wasserman has also been quoted in The Washington Post, The Washington Times, Vitamin Retailer, Urology Times, Traffic World, and New Nutrition Business.
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