- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
JAN 13, 2015
VIA OVERNIGHT DELIVERY
David Eben, CEO
297 Kinderkamack Road
Oradell, NJ 07649
Dear Mr. Eben:
This is to advise you that in April 2014, the Food and Drug Administration (FDA) reviewed your product label for Carrington Farms Coconut Oil (54 fl oz). In addition, FDA reviewed labeling on your website at the Internet address http://carringtonfarms.com/ in August 2014 and has determined that you take orders there for the product Carrington Farms Coconut Oil, which both the product label and the website labeling promote for conditions that cause the product to be a “drug” under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your product label and your website labeling establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
Even if your product was not an unapproved new drug, it would be a misbranded food within the meaning of section 403(r)(1) of the Act [21 U.S.C. § 343(r)(1)] as described below.
Unapproved New Drug
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
- Under the webpage titled “Health Benefits”:
o “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).”
o “Lauric acid exhibits anti-viral, anti-microbial, and anti-fungal properties.”
o “Coconut Oil also has been known to: kill bacteria, ease acid reflux ... lower incidence of hemorrhoids ... soothes ear aches . . . reduces joint and muscle inflammation.”
o “[C]oconut oil may help prevent osteoporosis...”
o “Lauric acid [found in coconut oil] has been found to protect your heart by reducing total cholesterol…”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your product Carrington Farms Coconut Oil is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended use. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that its labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
Misbranded Food: Nutrient Content Claims
Even if your Carrington Farms Coconut Oil product was not an unapproved drug, it would also be a misbranded food within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label and labeling bear nutrient content claims but do not meet the requirements to make such claims.
Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (or, by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient on food labels and labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]. Your Carrington Farms Coconut Oil product is misbranded under section 403(r)(1)(A) of the Act because the product label and labeling bear the following nutrient content claims but fail to meet the requirements to make such claims as follows:
1. The label of your Carrington Farms Coconut Oil product bears an implied nutrient content claim, because it bears statements suggesting that because of its nutrient content the product may help consumers maintain healthy dietary practices, and those statements are made in connection with claims or statements about nutrients. The label of your Carrington Farms Coconut Oil product bears the claims “Healthy Foods,” “The healthiest oil on earth,” “Perfect for healthy . . . cooking,” and “Use as a healthy . . . replacement for butter or fat” in connection with the statement “Our unrefined . . . coconut oil is simply pressed and bottled so it retains its original nutrient content . . . No Trans & Hydrogenated Fats.” However, this product does not meet the requirements for use of the nutrient content claim “healthy” that are set forth in 21 CFR 101.65(d).
In accordance with 21 CFR 101.65(d)(2)(i), you may use the term “healthy” as an implied nutrient content claim on the label or in the labeling of a food such as coconut oil provided that the food, among other things, is “low saturated fat” as defined in 21 CFR 101.62(c)(2) (saturated fat content of 1 g or less per Reference Amount Customarily Consumed (RACC) and no more than 15 percent of calories from saturated fat). Furthermore, the product must contain at least 10 percent of the Daily Value per RACC of one or more of vitamin A, vitamin C, calcium, iron, protein, or fiber.
According to the Nutrition Facts label, this product contains 12 g of saturated fat per tablespoon (14 g) serving of food which is calculated as 83 percent of calories from saturated fat and thus far exceeds the maximum of 1 g of saturated fat per RACC and not more than 15 percent of calories from saturated fat [21 CFR 101.62(c)(2)]. Additionally, according to the Nutrition Facts label this product does not contain at least 10 percent of the Daily Value per RACC of one or more of vitamin A, vitamin C, calcium, iron, protein or fiber. Accordingly, this product does not meet the requirements for the use of the nutrient content claim “healthy” on a food label [21 CFR 101.65(d)(2)].
2. Your website states: “These oils [components of coconut oil] are low in calories.”
Nutrient content claims for calorie content are defined in 21 CFR 101.60. Under 21 CFR 101.60(b)(2), the term “low in calories” may be used on the label or labeling of foods such as coconut oil provided that, among other things, the food does not provide more than 40 calories per RACC and per 50 g. However, according to the Nutrition Facts label, this product contains 130 calories per 14 g serving, which is more than the maximum of 40 calories per RACC and per 50 g allowed under 21 CFR 101.60(b)(2).
3. Your website states: “Coconut oil is rich in antioxidants.”
Nutrient content claims using the term “antioxidant” must comply with the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, an RDI must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(g)(l)], and these nutrients must have recognized antioxidant activity [21 CFR 101.54(g)(2)]. The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e) [21 CFR 101.54(g)(3)]. For example, to bear the claim "rich in antioxidant vitamin C," the product must contain 20 percent or more of the RDI for vitamin C under 21 CFR 101.54(b). Such a claim must also include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity [21 CPR 101.54(g)(4)]. The antioxidant claim on your website does not indicate the names of the nutrients that are the subject of the claim or link the nutrients with the claim by use of a symbol.
Misbranded Food: Unauthorized Health Claims
Your Carrington Farms Coconut Oil product is also misbranded within the meaning of section 403(r)(l)(B) of the Act because the labeling on your website includes the following unauthorized health claims:
1. "Coconut oil is made up of medium chain fatty acids (MCFA). These fatty acids . . . are known to lower the risk of heart disease and arteriosclerosis."
There are no health claims authorized by regulation or the Act that provide for claims relating coconut oil or MCFAs to heart disease or arteriosclerosis.
2. "Coconut oil may lower the risk of diabetes, heart disease and improve cholesterol levels. Studies show people who take coconut oil improved their cholesterol profile along with higher HDL levels and higher HDL:LDL ratio."
Because high blood total- and low density lipoprotein (LDL)-cholesterol levels are associated with increased risk of developing coronary heart disease, the claim that your product “improve(s) cholesterol levels” and “improve[s] [the consumer’s] cholesterol profile along with higher HDL levels and higher HDL:LDL ratio” implies that your product is intended for use in the treatment, mitigation, and prevention of coronary heart disease. There are no health claims authorized by regulation or the Act that provide for claims relating coconut oil to coronary heart disease. There are also no health claims authorized by regulation or the Act that provide for claims relating coconut oil to diabetes.
The above violations are not meant to be an all-inclusive list of violations that exist in connection with your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter and to prevent their reoccurrence. Failure to promptly correct the violations may result in legal action without further notice, such as seizure or injunction.
In addition to the violations cited above, we offer the following comments:
1. The statement for the place of business does not include the street address in accordance with 21 CFR 101.5(d). We note that the street address may be omitted if it is shown in a current city directory or telephone directory.
2. Your Carrington Farms Coconut Oil bears the claim “No Trans & Hydrogenated Fat,” and we note that your ingredient statement lists coconut oil and does not include a partially hydrogenated oil as an ingredient in the ingredient list. Under section 403(r)(1)(A) of the Act, a nutrient content claim in food labeling must be made in accordance with a regulation authorizing the use of the claim in order for the food bearing such claim not to be misbranded. Although FDA has not defined the term “no trans-fat” by regulation, we announced in the Federal Register dated July 11,2003 [68 FR 41507 at 41509] that we would likely consider exercising enforcement discretion for a trans-fat nutrient content claim that is demonstrably true, balanced, adequately substantiated, and not misleading.
Scientific evidence suggests that trans-fat acts in a similar manner to saturated fat with respect to raising LDL cholesterol [68 FR 41445 at 41456 (July 11, 2003)]. Higher total and LDL cholesterol levels are associated with increased risk of developing coronary heart disease [68 FR 41445 (July 11, 2003)]. Under 21 CFR 101.13(h), if a food bears a nutrient content claim and also contains more than 13.0 grams of fat, 4.0 grams of saturated fat, 60 milligrams cholesterol, and 480 milligrams of sodium per reference amount customarily consumed (RACC), per labeled serving (or for a food with a RACC of 30 grams or less or 2 tablespoons or less, per 50 grams), then the food must bear a statement disclosing that the nutrient exceeding the specified level is present in the food as follows: “See nutrition information for ______content” with the blank replaced with the identity of the nutrient exceeding the specified level. Your Carrington Farms Coconut Oil contains 12 g of saturated fat per RACC (1 tbsp. serving) but does not contain the disclosure statement “See nutrition information for saturated fatcontent.”
We intend to consider the exercise of our enforcement discretion for the use of the “No Trans & Hydrogenated Fat” claim on Carrington Farms Coconut Oil provided the claim includes a disclosure statement, in accordance with the requirements in 21 CFR 101.13(h). We will review such claims on a case-by-case basis.
Please respond to this letter within 15 working days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
You should direct your written reply to Carrie Lawlor, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Lawlor via email at email@example.com
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition
cc: FDA New Jersey District