The agency also puts coconut product makers on notice that claims coconut products are antiviral, can reduce bad cholesterol or help consumers manage diabetes are improper therapeutic claims for foods, according to previously issued warning letters. FDA explains such claims technically make the products unapproved new drugs because they suggest coconut ingredients can cure, mitigate, treat or prevent disease, according to the warning letters.
Saturated fat content restricts "healthy" claims
The agency explains in the most recent warning letter posted on its website Oct. 14 that Premier Organics cannot make implied or explicit claims that its Artisana Coconut Butter Whole Coconut Flesh product is “healthy” because it contains too much saturated fat per serving.
The Oakland, Calif.-based firm's Artisana Coconut Butter product claims on its label that it is a “healthy … food” and references “The Art of Healthy Foods” in connection with the statement “preserves the life-essential fatty acids, enzymes, vitamins and minerals,” according to the letter. However, it contains 16 grams of saturated fat per serving and, according to FDA regulations, products claiming to be "healthy" must contain 1 gram or less of saturated fat per reference amount customarily consumed and no more than 15% of the calories can come from saturated fat.
“You will never be able to say the word 'healthy' with coconut products because coconut is so high in saturated fats,” said Justin Prochnow, a food and drug lawyer with Greenberg Traurig in Denver. Unrelated coconut waters do not have the same problem because they do not contain saturated fat, he added.
“Healthy is one of those words that people don’t realize is a very specific nutrient content claim” that can be used only if a food is low in fat and saturated fat, has limited sodium and cholesterol and at least 10% of the recommended daily intake of vitamin A or C, calcium, iron, protein or fiber, Prochnow explained.
FDA also cited the firm for making the unsupported nutrient content claim: “good source of essential amino acids.” The agency explained that, like “healthy,” claims that a product is a “good source” of a nutrient must meet specific regulatory requirements, including containing 10% to 19% of the nutrient’s daily value per RACC. However, FDA notes, “because there is no DV for amino acids … the use of the term ‘good source’ to characterize the level of amino acids in your product misbrands your product” under the food and drug law.
A “minor” violation
The warning letter also is notable because the violations were “minor,” and yet, the FDA went to the trouble of sending and posting the letter, Prochnow said.
FDA taking time to cite such a minor violation without noting other problems raises the question: “Why is FDA doing this? Does it have an ulterior purpose,’” such as alerting manufacturers to a potentially widespread problem? Prochnow asked.
Despite the odd circumstances of the letter, he said, “I don’t see this as an example of [FDA saying], ‘Watch out coconut world,’” but more of a gentle reminder that the “the words you use matter.”
“You can’t just toss around ‘good source,’ or ‘healthy,’ or ‘rich in’ or ‘high in’ because these are specifically regulated terms and you have to make sure you are compliant,” Prochnow said.
Even if a product does not qualify to claim it is healthy under the regulations, “there are ways to inform consumers about the health benefits of a food, or the amounts of beneficial ingredients in a food, without running afoul of FDA’s nutrient content claim regulations,” said Ivan Wasserman, a partner specializing in food and drug law with Manatt, Phelps & Phillps.
For example, he said firms can list the specific amount of a nutrient or vitamin in a serving on labeling and simply not characterize them as high, low or good.
However, he added, if the nutrient amounts are low, manufacturers should approach such claims “like porcupines making love, which is to say carefully.”
Watch out for drug claims
FDA also reminds food makers in earlier letters that claims coconut oil and other products with the fruit flesh or sugar are antiviral, can lower cholesterol or help regulate blood glucose levels are drug claims and inappropriate for foods.
In a 2012 warning letter to Hail Merry, the agency said claims the Dallas firm’s granola and Miracle Tart Chocolate with coconut oil could not make claims to ”improve our cholesterol profile” because it contains large amounts of lauric acid, which some studies show can raise HDL, or good cholesterol, levels.
Nor could it claim coconut oil “can reduce the symptoms of type 2 diabetes” and “help regulate blood glucose levels,” FDA said. These claims may be tempting to make for products made with coconut sugar, which is trending up, according to Sterling Rice Group, because it has a lower glycemic index score than sucrose (click HERE).
In addition, claims that coconut milk powder containing monolaurins and lauric acid in Cerebral Health’s Alzenia Anti-Aging Brain Formula can “act as powerful antiviral agents” triggered a warning letter in 2010 for improper drug claims.
Similar claims by Optimal Wellness Center prompted a warning letter from FDA in 2005. The agency said claims Tropical Traditions Virgin Coconut Oil can “reduce the risk of heart disease” and “is very beneficial in attacking viruses, bacteria and other pathogens” made the food a “new drug,” according to regulation.
Increasing Product Launches, Competition
Manufacturers and marketers should take heed of these lessons as they continue to launch more coconut products – beyond water – into a crowded and competitive category.
Market analysis by Mintel estimates the use of coconut oil in foods and beverages accounted for 26% of new product launches in 2012 – up from 15% in 2008.
Coconut palm sugar also grew 320% from 2008 to 2012, Mintel added.