WARNING LETTER
Evimeria El Aztecano, Inc.
MARCS-CMS 624797 —
November 16, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Dietary Supplements
Recipient:
Recipient Name
Michael A. Vizcarrondo
Recipient Title
Owner
Evimeria El Aztecano, Inc.
1460 W. 135th St.
Gardena
,
CA
90249-2218
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
WL 624797
November 16, 2022
Dear Mr. Vizcarrondo:
This is to advise you that the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1460 W. 135th St., Gardena, CA from November 2, 2021, through November 10, 2021. During the inspection, our investigators collected labeling for your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” dietary supplement. Based on our subsequent review of the product labeling, we have concluded that this product is in violation of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) and the regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). FDA received your response to FDA’s Form 483, Inspectional Observations, on February 4, 2022. You can find the Act and FDA regulations through links on the FDA’s home page at
http://www.fda.gov.
Misbranded Dietary Supplements
1. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because its labeling is false or misleading. Specifically:
a) Our sampling analysis of your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” dietary supplement
(b)(4)
independent determinations of potassium. Magnesium and potassium are Class II minerals as defined in 21 CFR 101.9(g)(3). Because your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” dietary supplement does not contain levels of magnesium or potassium at least equal to 80 percent of the value declared on the label for each nutrient, as required by 21 CFR 101.9(g)(4)(ii), the product’s label is false or misleading.
2. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” 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 nutrient content claims but does not meet the requirements to bear such claims. Under sections 403(r)(1)(A) and (2)(A)(i) 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. Under 21 CFR 101.13(b), a claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling under 21 CFR 101.9 or under 21 CFR 101.36 (that is, a nutrient content claim) may not be made on the label or in labeling of foods unless the claim is made in accordance with 21 CFR 101.13 and with the applicable regulations in 21 CFR Part 101 subpart D or in Part 105 or Part 107. An implied nutrient content claim includes any claim that describes the food or an ingredient therein in a manner that suggests that a nutrient is absent or present in a certain amount (21 CFR 101.13(b)(2)(i)). Characterizing the level of a nutrient in the food 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. Specifically,
a) Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product label displays the following claim “Canary Seed … is high in protein content.” In the context of this label, FDA considers the claim “Canary Seed . . . is high in protein content” to be an implied claim about the food itself. In accordance with 21 CFR 101.54(b), the terms “high,” “rich in,” or “excellent source of” may be used to characterize the level of a nutrient on the label and in the labeling of foods provided that the food contains 20 percent or more of the Reference Daily Intake (RDI) or the Daily Reference Value (DRV) per reference amount customarily consumed (RACC). The DRV for protein is 50 grams (g), and the RACC for your product is 2 Tablespoons. According to the Supplement Facts label, your product contains 2.6 g of protein per 2 Tablespoons, which is only 5% of the DRV (rounded to the nearest whole percent). We also note that elsewhere on the Supplement Facts label indicates that protein per 2 Tablespoons is 12% with no clear indication as to what the percentage relates.
b) Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product label displays the following claim “Canary seed … It contains as much protein as meat …” In the context of this label, FDA considers this claim about canary seed, an ingredient in the food, to be an implied claim about the food itself. In accordance with 21 CFR 101.65(c)(2), the phrases “contains the same amount of [nutrient] as a [food]” and “as much [nutrient] as a [food]” may be used on the label or in the labeling of foods, provided that the amount of the nutrient in the reference food is enough to qualify that food as a “good source” of that nutrient, and the labeled food, on a per serving basis, is an equivalent, good source of that nutrient (e.g., “as much fiber as an apple,” “Contains the same amount of Vitamin C as an 8 oz. glass of orange juice.”). Under 21 CFR 101.54(c), the term “good source” may be used to characterize the level of a nutrient on the label and in the labeling of foods provided that the food contains 10 to 19 percent of the RDI or the DRV per RACC. As stated previously, the Supplement Facts label declares 2.6 g of protein per 2 Tablespoons of the product, which is only 5% of the DRV for protein; 5% protein is not within 10 to 19% of the DRV for protein and, therefore, your product does not qualify to be “an equivalent, good source.”
3. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutritional information on the labeling of your product does not comply with 21 CFR 101.36. For example:
a) The product label declares “Proprietary Blend … 610g”, that being the total net contents of the product. The use of “Proprietary Blend” with its quantitative amount is permitted in the Supplement Facts label but relative to the serving size. Furthermore, any “Proprietary Blend” declaration with its quantitative amount must be in accordance with 21 CFR 101.36(b)(3)(iii)(c).
b) The label fails to declare dietary ingredients by the correct name and in the correct order and format, per 21 CFR 101.36.
c) The declaration of calories is not in accordance with 21 CFR 101.36(b)(2) and 101.9(c)(1) in that the caloric content per serving is not expressed to the nearest 5-calorie increment up to and including 50 calories. Furthermore, the declaration does not appear to correlate with the declared quantitative amounts for the listed macronutrients.
d) The label fails to declare the quantitative amount by weight per serving of each dietary ingredient either in a separate column aligned to the right of the column of names or immediately following the listing of names within the same column. When information on the percent of Daily Values is listed, this information must be presented in one column aligned under the heading of "% Daily Value" and to the right of the column of amounts. The headings "% Daily Value (DV)," "% DV," "Percent Daily Value," or "Percent DV" may be substituted for "% Daily Value." The heading "% Daily Value" must be placed on the same line as the heading "Amount Per Serving." [21 CFR 101.36(b)(2)(iii)(A)]
e) Each quantitative amount declared for the carbohydrates, protein, and fat fail to use the level of significance given in 21 CFR 101.9(c)(8)(iv), in accordance with 21 CFR 101.36(b)(2)(ii)(B).
f) The label fails to include a heavy bar under “Servings per Container, as required by 21 CFR 101.36(e)(6).
g) The label fails to list (b)(2)-dietary ingredients in the correct order, as required by 21 CFR 101.36(b)(2)(i).
h) The title and all headings are not bolded to distinguish them from the other information, as required by 21 CFR 101.36(e)(1).
i) The label declares 0% for Vitamin A, Vitamin D, Vitamin B12, and cholesterol. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i).
j) The declared % Daily Values for protein and carbohydrate do not correlate with the quantitative amounts declared for each macronutrient.
k) The label declares “*Percent of daily value are based on a 2,000 calorie diet. Your daily value may be higher or lower depending on your calorie needs. Daily value has not been established.” There is no provision in the regulation for the “Your daily value may be higher or lower depending on your calorie needs.” in the Supplement Facts label. Other dietary ingredients (also known as (b)(3)-dietary ingredients) must bear a symbol (different than the symbol used for the 2,000 calorie diet statement) under the heading of the % Daily Value that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement “Daily Value not established.”
4. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product label contains information in two languages but does not repeat all of the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The product includes foreign language on the label but fails to declare the product name, all information in the Supplements Facts label, and the name and address of the responsible party in both languages.
5. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incomplete. Specifically, the product’s label fails to declare the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams) following the common household measure, as required by 21 CFR 101.9(b)(7).
6. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
7. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the label fails to declare the common or usual name of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(a) and (h). For example, the product’s batch product record indicates “canary seed (
Phalaris canariensis
).” The standardized common name for
Phalaris canariensis
is “canary grass”, as noted in Herbs of Commerce. Furthermore, the Supplement Facts label lists “guanabana” which is not a standardized common name listed in the reference Herbs of Commerce; soursop is the standardized common name for guanabana.” In addition, the batch record indicates “guanabana leaf powder”.
8. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product is misbranded within the meaning of Section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] because the labeling makes structure/function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b) and (c). Under section 403(r)(6) of the Act, a dietary supplement may bear certain claims, generally called "structure/function claims," on its label or in its labeling provided that the firm has substantiation that the claim is truthful and not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim; and the claim includes the mandatory disclaimer.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
We also offer the following comments:
1. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product label’s dietary supplement statement of identity is not presented in bold type on the principal display panel and in a size reasonably related to the most prominent printed matter on the principal display panel. (see 21 CFR 101.3(d))
2. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product label is not based upon the revised nutrition labeling regulation which became effective July 26, 2016. Labels were to comply with the revised labeling regulation by January 1, 2020, or January 1, 2021, depending upon the annual food sales of the manufacturer. When making revisions to your product label, you must comply with the current regulations. (see 21 CFR 101.9, 101.30, and 101.36)
3. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product label declares Vitamin C at a level of 214% Daily Value (DV) per serving; however, a review of the batch production record, packing slip and certificate of analysis for this product does not appear to indicate that the product contains ingredient(s) that would provide Vitamin C at a level of 214% DV per serving.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be directed to:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
Or emailed to ORAHAFWEST5FirmResponses@fda.hhs.gov.
Refer to the Unique Identification Number CMS 624797 when replying.
If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations- West Division 5
Content current as of:
01/24/2023
Regulated Product(s)
Dietary Supplements