By Sheldon Baker
Nutraceuticals World
Published May 18, 2012
Heather Van Blarcom recently joined dicentra and is a licensed attorney with more than 10 years of experience in the natural products industry. As a former general counsel, Van Blarcom brings a pragmatic and well-rounded expertise to issues impacting her clients. She has extensive experience in proactively helping companies achieve compliance with both FDA and FTC regulations including labeling and advertising review, claims review and substantiation, and GMP procedures and audits. She has guided companies through numerous new product launches in market segments such as weight loss, energy, and general wellness. Over the course of her career, she has developed many strong relationships inside the industry and within the governmental agencies that regulate it. Van Blarcom began her career in the natural products industry as a trial lawyer defending manufacturers and distributors of dietary supplements in both national product liability litigation and FTC matters where she advised clients on litigation strategies, the handling of adverse event reports, product recalls, and crisis management issues. Heather earned a bachelor of arts in quantitative economics and decision sciences from the University of California at San Diego and a juris doctorate from the California Western School of Law.
Health E-Insights: What pending legislation could impact the supplement industry?
Ms. Van Blarcom: There are currently two regulatory issues pending that will undoubtedly effect the way our industry does business. The first, is the ballot initiative in California to require GMO labeling that appears to have obtained enough votes to be placed on the November ballot in California. The second, are the revisions to the nutritional Daily Values (DVs) that are expected later this year. The proposed revisions, if adopted by the FDA, are likely to cause confusion among consumers in that they are likely to think they are getting 100% of what they need. DVs have always been based on the Highest Recommended Dietary Allowance (RDA) which is the average daily dietary intake of a nutrient that is sufficient to meet the requirements of nearly all healthy persons. Now, instead, the DVs will be based on the Estimated Average Requirement (EAR), the amount of a nutrient that is estimated to meet the requirements of approximately half of all healthy individuals in the population. Thus many of the DVs for nutrients would be lowered, some dramatically, because EARs are generally about 20 percent less than RDAs. The proposed new values would focus merely on preventing nutrient deficiencies rather than focusing on nutrient optimization necessary for achieving optimal health benefits.
Health E-Insights: Can foreign companies easily bring product into the U.S.?
Ms. Van Blarcom: While importation has its risks, familiarity with the process and the regulatory requirements will help streamline the process. FDA does not approve, certify or otherwise license individual products or their associated labels. However, those manufacturing or selling products in the U.S. are responsible for ensuring their products are safe, sanitary, labeled according to U.S. regulatory requirements, and manufactured in accordance with cGMPs. Lastly, companies need to be sure they comply with the registration requirements under the Bioterrorism Preparedness and Response Act of 2002 as well as requirements of The Food Safety Modernization Act.
Health E-Insights: Can U.S. companies easily bring products into Canada?
Ms. Van Blarcom: Yes. It is easier than one might think. While Canada does require premarket approval for its products, it should not be a deterrent for U.S. companies. Since U.S. companies are already required to maintain scientific substantiation in their files it is merely a matter of submitting that information in a format acceptable to Health Canada. Any additional scientific research required will only serve to bolster your substantiation files for your U.S. claims. Additionally, Canada allows claims, where appropriate, beyond the more limited U.S. structure/function claims allowed for dietary supplements. The U.S. company will also need to assign a company within Canada as their importer. This Canadian entity is required to have a special permit called a site license from Health Canada allowing it to import dietary supplements. They would need to demonstrate that the U.S. manufacturer complies with Canada’s GMP requirements before any importation could begin. If the manufacturer has been audited by the FDA for dietary supplement cGMPs and has taken all corrective actions then this process is very straightforward.
Health E-Insights: What is your role at dicentra?
Ms. Van Blarcom: As part of the dicentra team, I primarily help guide companies in developing strategies for regulatory compliance in the U.S.
Health E-Insights: What do you consider your greatest achievement?
Ms. Van Blarcom: As an attorney in private practice, my first trial victory will always be high on my list of accomplishments of which I am proud. As an in-house counsel for numerous dietary supplement companies, the metric of accomplishment changes and I take great pride in having played a key role in successfully guiding several companies through the regulatory process, keeping them in compliance and out of harm’s way. On a personal level, I have two great children and a loving husband that enrich my life in so many ways.
Health E-Insights: What is your greatest fear?
Ms. Van Blarcom: That unscrupulous bad actors in the natural product industry will lead to a tipping point in government wherein the industry will be subjected to overregulation thereby likely denying the public access to products that help them lead healthier lives.
We can be reached at 1-866-647-3279 or at dicentra.com