Public Health Service Food and Drug Administration
College Park, MD 20740
APR 2, 2015
VIA OVERNIGHT MAIL
Rob Wunder, Co-Founder
Yummy Earth Inc
79 N Franklin Tpke, Suite 200
Ramsey, NJ 07446-2029
Dear Mr. Wunder,
The Food and Drug Administration (FDA) reviewed the labels for your YumEarth Organics organic pops in March, 2015. Based on our review, we have concluded that this product is in violation of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and its implementing regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
Your YumEarth Organics organic pops product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim.
Specifically, the label of your YumEarth Organics organic pops product bears an implied nutrient content claim because it bears a statement suggesting that the product may be useful in maintaining healthy dietary practices, and that statement is made in connection with a claim or statement about a nutrient. Specifically, the label of your YumEarth Organics organic pops product bears the claim “YumEarth was born…to feed our families a diet rich in delicious healthful foods…” in connection with the statement “100% Daily Vitamin C.”
Under section 403(r)(1)(A) of the Act, 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 authorizing the use of such a claim. Characterizing the level of a nutrient on the food labeling of a product without complying with the specific requirements pertaining to the nutrient content claim for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
However, your product does not meet the requirements for use of a “healthy” nutrient content claim that is set forth in 21 CFR 101.65(d)(2). In accordance with 21 CFR 101.65(d)(2)(i), you may use the term “healthy” or “healthful” as an implied nutrient content claim on the label or in the labeling of a food provided that the food, among other things, contains at least 10% of the RDI or the DRV per Reference Amount Customarily Consumed (RACC) for one or more of vitamin A, vitamin C, calcium, iron, protein, or fiber. Additionally, in accordance with 21 CFR 101.65(d)(2)(iv), if the nutrient is added to the food to meet the 10% requirement, that addition must be in accordance with the fortification policy for foods in 21 CFR 104.20.
According to the Nutrition Facts panel, your YumEarth Organics organic pops product contains 100% of the Daily Value for vitamin C per serving. This product is fortified with ascorbic acid to contribute vitamin C to the product. The fortification of snack foods such as candies is not consistent with the fortification policy in 21 CFR 140.20. Accordingly, your product does not meet the requirements for use of a “healthy” nutrient content claim on a food label [21 CFR 101.65(d)(2)]. Your product is thus misbranded within the meaning of section 403(r)(1)(A) of the Act.
The above violation is not meant to be an all-inclusive notice of violations that may exist in connection with your products or their labeling. It is your responsibility to ensure that your products comply with the Act and its implementing regulations. You should take prompt action to correct this and similar violations. Failure to promptly correct the violation may result in regulatory action without further notice, including seizure and/or injunction.
In addition, we offer the following comment:
Your YumEarth Organics organic pops product label bears the claim “Made with Real Fruit Juice;” however, the ingredient statement does not identify the currant and apple ingredients as juices.
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 violation 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 firstname.lastname@example.org.