Maryland-based FDA consulting firm, FDAImports.com, has launched five new labeling websites that allow companies with products that are regulated by the U.S. Food and Drug Administration to receive a label review in order to identify any compliance issues with their product label. The streamlined process allows users to easily upload their label files for free, get a reasonable and flat-rate estimate, pay online and receive a comprehensive label review report in as little as three days. The report provides a detailed analysis of every inch of the product label, identifying what is compliant, what isn’t 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.
With separate label review websites for the food, drug, supplement, cosmetic and homeopathic industries, companies can drastically reduce the time and costs associated with FDA compliance, especially if the label review occurs before the product goes to print or ships. This is preventative maintenance at its best.
“Labeling compliance is more important than ever,” said Benjamin England, founder and CEO of FDAImports.com, the consulting firm that created the sites. “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.” Many companies aren’t even aware that they have non-compliant labeling claims until the FDA stops their product from being distributed. In fact, some claims 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.
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 severe loss of profit or even shut down the company itself. “We hope that these new label review sites can help reduce labeling errors across the board for all products,” said Benjamin England. “It’s not just smart business for food or cosmetic companies, it actually helps make the landscape safer for consumers.” The new labeling websites are: