A product labeled as a dietary supplement cannot be represented as a conventional food.
In a warning letter last month, FDA reminded a company of this fact.
Natures Health Options LLC, which distributes Charantea Bitter Melon Ampalaya in 500-mg capsules and as tea bags, was accused of making statements on its website that represent the product as a traditional food.
"If a product is labeled as a dietary supplement but does not meet the definition of a dietary supplement, e.g., because it is represented for use as a conventional food, the product is misbranded" under the Federal Food, Drug and Cosmetic Act (FDCA) because "the description of the product as a dietary supplement is false and misleading," an FDA official wrote in the letter to Natures Health Options president Joseph Buenconsejo.
FDA highlighted statements on the website that referenced Charantea as "a great alternative to coffee or traditional teas" and "your healthy after-meal beverage." Natures Health Options describes the product as a vegetable and medicinal herb that grows in Asia and South America.
In December 2009, the FDA issued draft guidance outlining factors that distinguish a liquid dietary supplement from a beverage. Justin Prochnow, a dietary supplement lawyer in Denver, noted FDA has indicated that final draft guidance is forthcoming.
"Is this letter a sign that the final guidance is coming soon? If nothing else, it is a very good reminder that you must be extremely careful making any representations about your product, not just the claims on the label," Prochnow said in an email Tuesday to the media. "Claims on websites and in other marketing and advertising can and will be used by FDA as evidence of the company's true intent to sell the product."
FDA also advised Natures Health Options that it is ultimately responsible for current good manufacturing practices (cGMPs) even if it hires contract manufacturers. A number of other supplements firms, including Pristine Bay LLC, have received similar warnings. Following an inspection of its facilities in Boca Raton, FL, last summer, the agency contends the company violated a number of cGMPs.
"Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement cGMP requirements," Emma Singleton, FDA's Director of the Florida District, wrote in the letter.
Natures Health Options did not immediately respond Tuesday to an emailed request for comment on the warning letter.
