• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Section Contents Menu

Enforcement Actions

Hail Merry, LLC 10/23/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

October 23, 2012

2013-DAL-WL-006

WARNING LETTER

UPS OVERNIGHT

Sarah P. Chapin, Chief Executive Officer
Susan O'Brien, Owner
Hail Merry, LLC
8805 Sovereign Row, Suite 101
Dallas, TX 75247

Dear Ms. Chapin and Ms. O'Brien:

The U.S. Food and Drug Administration (FDA) inspected your food manufacturing facility located at 8805 Sovereign Row, Suite 101, Dallas, Texas from October 17 through 19, 2011. During this inspection we collected labels for your food products Grawnola Orange Cranberry (1.75 oz), Merry's Miracle Tart Chocolate (3 oz), Almonds Vanilla Maple (1.75 oz), and Sunflower Seeds Salt n Black Pepper (4 oz). We also reviewed your website at www.hailmerry.com. Based on our review of your labels and your website, we have concluded that your products are in violation of sections 403, 505(a), and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links in FDA's website at www.fda.gov .

Unapproved New Drugs

Your labeling, including your product labels and your website, www.hailmerrv.com, promotes your food products for conditions that cause the products to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your labeling establish that your products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. The marketing of these products with these claims violates the Act.

Examples of some of the claims found on your website include:

From the brochure located on your webpage entitled "Why"

• "Raw nuts and cold pressed coconut oil [ingredients in many of your products such as Merry's Miracle Tart Chocolate, Almonds Vanilla Maple,
and Grawnola Orange Cranberry] ... improve our cholesterol profile . . . [and] reduce inflammation . . .. "
• "Coconut oil [an ingredient in many of your products such as Merry's Miracle Tart Chocolate] helps to reduce bad cholesterol!"
• "Coconut oil contains large amounts of Lauric Acid which is anti-viral . ... "

From the webpage entitled "Category Archives: Diabetes" which can be accessed from your website by clicking on the link "Biog" and then clicking on the link "Diabetes"

• "Coconut Oil Can Reduce the Symptoms of Type 2 Diabetes"
• "Diabetics can use coconut oil to help regulate blood glucose levels . ... Luckily, Hail Merry offers a variety of raw, vegan and gluten-free snacks that contain coconut oil."

From the webpage entitled "Category Archives: Celiac Disease" which can be accessed from your website by clicking on the link "Slog" and then clicking on the link "Celiac Disease"

• "[W]hile going gluten-free [all of your products are labeled as gluten-free] is costly ... the benefits are enormous including finding relief from the symptoms of multiple sclerosis, rheumatoid arthritis, chronic fatigue, migraines, irritable bowel syndrome and even infertility ... . "
• "Jenny McCarthy went gluten-free along with her son Evan and even says that the diet has played an essential part in Evan's recovery from autism . .

. . Join the movement and check out Hail Merry gluten-free snacks."

Further, your Almonds Vanilla Maple product label also contains the following claim:

"Research suggests that eating about a handful of almonds each day can help lower cholesterol levels"

Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321 (p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)). 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, because your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions for use cannot be written so that a layperson can use the drug safely for its intended uses. Thus, the labeling fails to bear adequate directions for use, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of misbranded drugs into interstate commerce is a violation of § 301 (a) of the Act [21 U.S.C. § 331 (a)].

Misbranding Violations

Even if your Grawnola Orange Cranberry, Merry's Miracle Tart Chocolate, Almonds Vanilla Maple, and Sunflower Seeds Salt n Black Pepper products did not contain claims on your labeling that cause them to be unapproved new and misbranded drugs, they would still be misbranded foods under section 403 of the Act (21 U.S.C. § 343) in that the labels for these products do not comply with the food label requirements in 21 CFR Part 101 as follows:

1. Your Merry's Miracle Tart Chocolate product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label bears a false and misleading claim "good fats." This claim is false and misleading because of the high levels of saturated fat in the products. As discussed below, the correct serving size for your product should be one tart. One tart is 85g, and contains approximately 12g of saturated fat, which is 60% of the DV for saturated fat.

The relationship between saturated fat intake and risk of coronary heart disease is well established (DHHS and USDA, Dietary Guidelines for Americans, 2005, 6th Edition, Washington, D.C., U.S. Government Printing Office, January 2005). Because of the high level of saturated fat in your Merry's Miracle Tart Chocolate product, the claim "good fats" is false and misleading.

2. Your Grawnola Orange Cranberry, Merry's Miracle Tart Chocolate, Almonds Vanilla Maple, and Sunflower Seeds Salt n Black Pepper products are misbranded within the meaning of section 403(r)(1)(A) of the Act, 21 U.S.C. §343(r)(1)(A), because the labels bear nutrient content claims, but the products do not meet the requirements to bear the claims. 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 in food labeling 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. For example:

• Your Grawnola Orange Cranberry, Almonds Vanilla Maple, and Sunflower Seeds Salt n Black Pepper product labels contain the nutrient content claim, "RICH IN OMEGAS". Although various nutrient content claims for ALA, DHA, and EPA omega-3 fatty acids have been statutorily authorized through the notification procedure in section 403(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)], the claims for Omegas on your labels do not meet the requirements for any of these claims. Specifically, among other requirements, the claims authorized under the notification procedure must specify whether the claim is referring to ALA, DHA, or EPA omega-3 fatty acids.1

• Your Merry's Miracle Tart Chocolate product label bears the nutrient content claim "Coconut oil is cholesterol free." However, your product does not meet the requirements in 21 CFR 101.62(d)(1) to bear this claim because your products do not contain 2 g or less of saturated fatty acids per reference amount customarily consumed (RACC) and per labeled serving. According to your nutrition information, a 28 g serving of Merry's Miracle Tart Chocolate contains 4 g of saturated fat.

• Your Grawnola Orange Cranberry product label bears the nutrient content claim "Cranberries are loaded with antioxidants." Nutrient content claims using the term "antioxidant" must comply with, among other requirements, the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a reference daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(g)(1)], 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 "high 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 CFR 101.54(g)(4)]. The antioxidant claim found on your product labels is a nutrient content claim because it characterizes the level of antioxidants in your products, but it does not comply with 21 CFR 101.54(g)(4) because the claim does not include the names of the nutrients that are the subject of the claim or link the nutrients with the claim by use of a symbol.

• Your Sunflower Seeds Salt n Black pepper product label contains the nutrient content claim "[R]ich source [of] ... iron ." A product that claims to be "rich" in a nutrient must contain at least 20 percent of the RDI per RACC for the nutrient as required by 21 CFR 101 .54(b). Based upon your nutrition information, a 28 g serving contains 10 percent of the RDI for iron. This equates to approximately 11% of RDI per RACC. Therefore, your product does not meet the requirements to bear a "rich" claim for iron. In addition, your Sunflower Seeds Salt n Black pepper product label contains the nutrient content claim "[R]ich source [of] . . . B vitamins, vitamin E as well as minerals copper, manganese, potassium, and magnesium, however the nutrient levels are not declared for these vitamins and minerals as required under 21 CFR 101.9(c)(8)(ii) and 101.13(n). Therefore the product is misbranded under section 403(q) and 403(r)(1)(A) of the Act. Further, because these nutrient levels are not declared, it is not clear whether the product has the required minimum 20 percent of the RDI per RACC of these nutrients as required under 21 CFR 101.54(b).

• Your website also bears the implied nutrient content claim, "healthy" for your Grawnola Orange Cranberry, Merry's Miracle Tart Chocolate, Almonds Vanilla Maple, and Sunflower Seeds Salt n Black Pepper products. Examples of these claims include:

From the webpage entitled "Category Archives: Diabetes" which can be accessed from your website by clicking on the link "Biog" and then clicking on the link "Diabetes"

> "Hail Merry Snacks are perfect healthy snacks for diabetics .... "

From the webpage entitled "Rawk the Party 20 pack-Chocolate Miracles Tarts in reference to the Merry's Miracle Tart Chocolate product

> "The perfect indulgence (but one that's healthy!) ... . "

From the webpage entitled "Break Room Snacks Assortment" which includes the Grawnola Orange Cranberry, Almonds Vanilla Maple and
Sunflower Seeds Salt n Black Pepper products

> "There's no reason your office breakroom or pantry shouldn't have ... . healthy snacks on hand . ... "

However, these products do not meet the requirements for use of the term "healthy" as set forth in 21 CFR 101.65(d)(2). To bear an implied nutrient content claim using the term "healthy," foods must meet the following requirements:

(1) Must be "low fat" as defined in 21 CFR 101.62(b)(2) (total fat content of 3 g or less per RACC);
(2) Must be "low saturated fat" as defined in 21 CFR 101.62(c)(2) (saturated fat content of 1 g or less per RACC and no more than 15 percent of calories from saturated fat);
(3) Must not exceed the disclosure level for cholesterol set forth in 21 CFR 101.13(h) (60 mg cholesterol per RACC);
(4) Must contain at least 10% of the Daily Value per RACC of one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein, or fiber; and
(5) Must contain no more than 480 mg sodium per RACC and per labeled serving.

Your products Grawnola Orange Cranberry, Merry's Miracle Tart Chocolate, Almonds Vanilla Maple, and Sunflower Seeds Salt n Black
Pepper do not meet the definition of low fat. In addition, your Merry's Miracle Tart Chocolate does not meet the definition of low in saturated fat.

• Your Sunflower Seeds Salt n Black Pepper product label bears the claim "rich source [of] linoleic acid" and your brochure on your webpage entitled "Enlighten" under the heading "Hail Merry is a Certified Gluten-free Kitchen" bears the claim "Buckwheat groats [ingredient in Grawnola Orange Cranberry] are . . . loaded with amino acids." These claims characterize the levels of nutrients of the type required to be in nutrition labeling in your products by use of the terms "rich source" and "loaded with ." Even if we determined that the term "loaded with" could be considered synonymous with a term defined by regulation (e.g., "good source" or "high"), these claims do not comply with the requirements in 21 CFR 101.54(b) because there is no established RDI or DRV for linoleic acid or amino acids.

3. Your Grawnola Orange Cranberry, Merry's Miracle Tart Chocolate, Almonds Vanilla Maple and Sunflower Seeds Salt n Black Pepper products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not declared in accordance with 21 CFR 101.9. Specifically,

• Your Sunflower Seeds Salt n Black pepper product label contains the nutrient content claim "[R]ich source [of] ... B vitamins, vitamin E as well as minerals copper, manganese, potassium, magnesium, and iron ." As required by 21 CFR 101.9(c)(8)(ii), the declaration of vitamins and minerals as a percent of the RDI shall include vitamins A, vitamin C, calcium, and iron, in that order, and shall include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) when they are added as a nutrient supplement, or when a claim is made about them. Also, as required by 21 CFR 101.9(c)(5), the declaration of the amount of potassium is required when a claim is made about potassium content. Your label fails to declare the percentage of B vitamins, vitamin E, copper, manganese, and magnesium and the amount of potassium.

• The serving size declared on your Merry's Miracle Tart Chocolate does not meet the requirements in 21 CFR 101.9(b)(2)(i). The serving size for products in discrete units shall be one unit if a unit weighs 67 percent or more, but less than 200 percent, of the reference amount. The RACC for Bakery Products, Pies, cobblers, fruit crisps, turnovers, other pastries is 125g (21 CFR 101.12(b), Table 2). Your label incorrectly declares the serving size as "(1/3 tart) (28g)." One tart weighs 85g which is 80% of the RACC; therefore your serving size should be one tart. The nutrition values and servings per container information provided on the label of your product must be based on the correct serving size.

• Your Grawnola Orange Cranberry, Almonds Vanilla Maple, and Sunflower Seeds Salt n Black Pepper products fail to list the serving size in common household measure in accordance with 21 CFR 101.9(b)(5), such as in cups, tablespoons, teaspoons, or, if appropriate, the number of pieces.

4. Your Grawnola Orange Cranberry product is misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], because it is fabricated from two or more ingredients, but the label fails to declare the common or usual name of each ingredient in the product in accordance with 21 CFR 101.4. Specifically, your product lists, "Evaporated Cane Juice" in the ingredient statement; however, evaporated cane juice is not the common or usual name of any type of sweetener. The proper way to declare this ingredient can be found on the FDA website at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm181491.htm.

The above list is not intended to be an all-inclusive list of violations in your products, labels, and labeling. It is your responsibility to assure that the products you market are in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter and prevent their recurrence. Failure to take appropriate corrective action may subject your firm and products to further actions, such as injunction or seizure.

We also note that your webpage entitled "Category Archives: Diabetes" which can be accessed from your website by clicking on the link "Slog" and then clicking on the link "Diabetes" bears the statement "Hail Merry Snacks are perfect healthy snacks for diabetics .. . . ". Prior to June 1996, there was a special dietary regulation (21 CFR 105.67) that provided for the special dietary claim "may be useful in the diet of diabetics" on food product labels. In the Federal Register (FR) of June 3, 1996 (61 FR 27771), FDA revoked 21 CFR 105.67. FDA concluded, consistent with current dietary advice, that the provisions for diabetic labeling in 21 CFR 105.67 were outdated and misleading. The agency also stated in that Federal Register notice that the nutrient content and health claim provisions of the Act and section 403(a) would prevent any use of the term "diabetic" that is not scientifically valid or that is misleading. Therefore, we recommend you remove the language from the labeling of your snack products.

We also note that your Grawnola Orange Cranberry, Almonds Vanilla Maple, and Sunflower Seeds Salt n Black Pepper products bear the claim "NO REFINED SUGAR." However, the intent of your claim may not be clear to consumers and may mislead those who are seeking products that are sugar-free or contain no added sugar. We recommend that you clarify the meaning of your claim.

You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining violations.

Your written response should be sent to Seri L. Essary, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Ms. Essary at (214)253-5335.

Sincerely,

/s/

Reynaldo R. Rodriguez, Jr.
Dallas District Director

 

1 FDA issued a proposed rule (72 FR 66103, November 27, 2007) to prohibit some of these nutrient content claims for omega-3 fatty acids.