Creating a food, beverage or supplement label can be a tricky proposition. Health claims are closely regulated and word choice, copy size and placement details are also scrutinized. But problems arise when companies go to market, unaware of non-compliant label claims, until the FDA steps in. Of course there are potential dangers to the consumer, but from a company perspective, a minor labeling oversight could at best turn into an expensive post-production retraction, or at worst, a corporate disaster that can change a product’s regulatory classification from a cosmetic to a drug or from a drug to a food—with severe implications for the manufacturer.
To help companies take the guesswork out of labeling, FDAImports.com, a Glen Burnie, MD-based FDA consulting firm, hosts five separate websites that allow companies with U.S. FDA-regulated foods and beverages, supplements, cosmetics, drugs and homeopathic products to receive a label review to identify potential compliance issues with their product labels.
“Labeling compliance is more important than ever,” said Benjamin England, a former 17-year veteran of the FDA, who served as the regulatory counsel to the associate commissioner for Regulatory Affairs, and current founder and CEO of FDAImports.com. “FDA takes it very seriously and can prevent products from ever coming to market because of a misleading statement, health claim, incorrect Drug or Nutrition Facts panel or wrongly named ingredient.”
Mr. England self-professed soft spot for companies that sought to bring creative and quality products to market was the impetus behind the innovative start-up. “We have found that companies simply become overwhelmed with FDA’s requirements and that it’s actually getting worse, not better,” he said, nodding to the range of modern day obstacles that can prevent seemingly great new product ideas from getting to market. “We created these labeling websites so that companies on a budget, who are struggling to understand the regulations or who want to ensure the compliance of their labeling and claims, can get a quality regulatory product that will go a long way toward their overall success.”
Organized into a streamlined process, users upload their label files, receive a flat-rate cost estimate (which range from $1,250 to $2,250, depending on the product and complexity), pay online and receive a comprehensive label review report in about 10 days, five days with rush processing). The report provides a detailed analysis of “every inch” of the product label, identifying what is and isn’t compliant, and what could be changed in order to avoid problems with FDA. The regulatory background behind the recommendations is also provided so that companies can avoid making the same mistakes on future product labels.
Mr. England explained that he and his colleagues had a few key objectives in mind when they launched their label review websites. Their top two priorities were interface simplicity and affordability. “When companies deal with FDA they are overwhelmed with how complex and detailed it can be become,” he said. “We wanted to make the process as simple as possible.
“The second goal of the sites was to only market a single regulatory product, the label review, and to offer it at an affordable rate,” he continued. “A label review is one of the most important services we can provide companies with a small number of products or who are just starting out or entering the U.S. marketplace."
“A lot of companies come to us with complicated regulatory problems that could have been identified and dealt with in the very beginning—a label review would have been the perfect tool to identify some of their issues. If companies get their labels compliant before they print, ship or go to market then they’re going to save themselves a lot of headache down the road.”
With most importers and many domestic companies being small businesses, a container or shipment that’s refused, detained or destroyed by FDA can lead to a catastrophic loss of profit or even the shuttering of an entire company. “We hope that these new label review sites can help reduce labeling errors across the board for all products,” Mr. England said. “It’s not just smart business for food or cosmetic companies; it actually helps make the landscape safer for consumers.”
Fixing Labels Before They Become a Problem
FDAImports.com’s online label guidance resources identify potential compliance issues.
By Joanna Cosgrove, Online Editor
Published November 29, 2012