Government Accountability Office Issues Report On Herbal Supplement Marketing

Jun 01, 2010   

When speaking of deceptive claims the Federal Trade Commission (FTC) comes to mind.  When discussing a dietary supplement the Food and Drug Administration (FDA) rolls off the tongue.  But who regulates the regulators?  The U.S. Government Accountability Office (GAO) does.  The GAO is an independent, nonpartisan agency that acts as Congress? ?watchdog" by investigating how tax dollars are spent.  Last week the GAO released its 28 page report on Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice of Herbal Supplements.

Recent studies have noted a significant increase in the use of herbal dietary supplements by baby boomers.  These studies prompted the GAO to investigate dietary supplement selling practices, and whether the herbals, namely chamomile, echinacea, garlic, ginkgo biloba, and ginseng, contain contaminated or harmful substances.  Representatives of the GAO posed as aging customers seeking products that would provide them with certain health benefits.  The ?secret shoppers? questioned staff at both brick-and-mortar and mail order retailers about the potential health benefits of herbal dietary supplements and the possible interactions with over-the-counter (OTC) and prescription drugs.  (Excerpts of phone calls can be heard here.)  Additionally, they examined marketing claims from several dietary supplement websites and tested forty herbal supplements for hazardous contaminants such as lead, arsenic, mercury, cadmium, organichlorine pesticides, and organophosphorous pesticides.

The outcome of the investigation revealed that the retailers and websites reviewed repeatedly represented that a product could treat, cure or prevent diseases such as diabetes, cancer, Alzheimer?s and cardiovascular disease amongst others.  Claims that expressly state or infer the improvement of a disease state violate the Dietary Supplement Health Education Act of 1994 (DSHEA).  Moreover, some of the herbal supplement sellers made affirmative statements that a supplement can replace a prescription medication or that it was completely safe to take an herbal supplement with an OTC or prescription drug.  For example, at least one sales clerk indicated it was safe for a person taking aspirin as part of a blood-thinning regimen to also ingest ginko biloba to boost their memory.  However, the FDA has emphatically stated that a combination of ginko biloba and aspirin poses a risk of increased bleeding.  The GAO has turned over the details of its investigation to the FDA and the FTC for further action against the merchants for violating the statues and regulations promulgated by the respective agencies.  As to the product testing, 37 out of the 40 products contained a trace amount of at least one hazardous contaminant.  However, the levels did not rise to a level that would cause a health concern.

The impact of this report reaches far beyond dietary supplement industry; it resonates throughout the marketing and merchandising world.  The actions by the GAO demonstrate that inappropriate claims for any product or service could come under regulatory scrutiny regardless of venue, corporate size or revenue.  Marketers, merchants and web retailers should seek legal advice and training for all personnel to ensure compliance with the regulations and guidelines of the FTC and if necessary, other applicable regulatory agencies or governing bodies.  After all, that little old lady, mother pushing a baby in a stroller or the business executive who seems in a hurry may actually be a regulator in disguise. 

Fuerst Ittleman, PL has decades of experience in evaluating product claims, assisting in compiling product substantiation files as well as successfully litigating against the FDA and FTC.  We also work closely with marketers to review advertising materials and train personnel on regulatory compliance.  Please feel free to contact us at contact@fidjlaw.com  to discover how we can help your company with advertising advice, marketing review, to set up a personnel training program tailored to your company and its product, provide legal defense for an action involving deceptive trade practice.