Warning letter slams coconut oil marketer over disease claims

By Hank Schultz

- Last updated on GMT

Warning letter slams coconut oil marketer over disease claims
The Food and Drug Administration has issued a warning letter to a coconut oil manufacturer for violations that included making drug claims on specific chemical constituents of the oil.

The letter to New Jersey-based Carrington Farms detailed numerous drug claims.  Carrington sells coconut, chia and flax products. On its website, Carrington has broken down the benefits of coconut oil based on its constituents, such as caprylic acid and lauric acid.  

FDA detailed the following alleged disease claims (which were still visible on the company’s website as of Wednesday):

  • “Caprylic acid is considered to have many positive therapeutic qualities—some of which include treating and soothing various infections such as salmonella, ringworm, candidiasis and gastroenteritis...Caprylic acid is also excellent for dealing with bacterial infections…including certain Streptococcus species and Staphylococcus aureus).”
  •  “Lauric acid exhibits anti-viral, anti-microbial, and anti-fungal properties.”
  • “Coconut Oil also has been known to: kill bacteria, ease acid reflux ... lower incidence of hemorrhoids ... soothes ear aches . . . reduces joint and muscle inflammation.”
  • “[C]oconut oil may help prevent osteoporosis...”
  • “Lauric acid [found in coconut oil] has been found to protect your heart by reducing total cholesterol…”.

It’s not a matter of belief, nor of data

Justin Prochnow, shareholder in the law firm Greenberg Traurig, said it’s really irrelevant whether a company makes claims on its products based on belief, what it might consider an informed reading of the product’s history of use or actual research it may have done the product’s effects.  Disease claims are disease claims, and are prohibited anything outside of the pharmaceutical realm.

“That goes for any non drug product you might have. Structure/funciton claims are specifically authorized by DSHEA for dietary supplements. For food and beverage products, FDA has authorized claims on aroma, taste or nutritive value,”​ Prochnow told NutraIngredients-USA. “But even if you have all the science in the world that would suggest that one constituent of a food might have certain health benefits, as a practical matter you can’t sell a non drug to diagnose, treat or prevent a disease.”

Healthy?

Then there’s the matter of what’s good for you in terms of diet.  Proponents of coconut oil, including Carrington, claim a long list of benefits for the substance and often claim that it is a ‘healthy’ alternative to other fats, including trans fats and butter.  The trouble is that FDA regulates the use of the term ‘healthy’ on food labels, defining it among other things as a food that contains less than 15% of its calories from fat.  A ‘healthy’ food must also contain at least 10% of 10 percent of the Daily Value per reference amount customarily consumed (RACC) of one or more of vitamin A, vitamin C, calcium, iron, protein, or fiber. Thus no single constituent fat product, including omega-3s with reams of research behind them, can be labeled as ‘healthy’ in this sense.  Carrington also claims that coconut oil is “low in calories.”​  But most references list the calorie content of coconut oil to be similar to other vegetable oils, or about 120 calories per tablespoon.  And no oil comes close to FDA’s definition of “low calorie,”​ which is  40 calories per RACC and per 50 g.  On this scale, coconut oil comes in at 130 calories, FDA said.

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