You may find the story from FoodNavigation.com that is pasted below interesting. It involves LaneLabs, a supplement company that is under a consent decree due to making false claims on dietary supplement products. The FTC brought a suit against them due to new claims they were making stating that these claims violated the consent decree; however, the court ruled that the company indeed had data to substantiate the claims they were making and further stated that the company had made efforts to ensure compliance by conducting studies and hiring a compliance officer. It is also important to note that the court found that FTC did not bring evidence that consumers had complained about the products or had been harmed. The court also stated that the FTC and LaneLabs had a difference of opinion when it came to interpreting the data supporting the claims.
It is very rare for FTC to lose this type of case and demonstrates a point we often discuss with our clients: It is possible for experts to disagree when interpreting claims, regulations and scientific studies but good faith efforts to be compliant have value. Remember to always have a file of data regarding the structure function claims you make about your food or dietary supplement products. This file should include both supporting and contradictory studies and an analysis of the strength of the overall data. This data will help you craft claims that are compliant and be ready to answer any questions FDA or FTC may raise. I have worked on only one case where the FDA disagreed with our interpretation of the science supporting claims that were being made. Because the company involved had a data file on claim substantiation, we were able to respond to the FDA warning letter very quickly. We sent them a number of articles and never received a follow up complaint or regulatory action.
At Bioscience Translation & Application we are always ready to help you evaluate your marketing materials for regulatory compliance. We also offer claim substantiation services. While we hope you never need it, we are also able to provide support in the event FDA or FTC takes issue with your claims. Learn more at www.BioTransApp.com