WARNING LETTER
APS BioGroup, Inc MARCS-CMS 521574 —
- Recipient:
- APS BioGroup, Inc
United States
- Issuing Office:
- Los Angeles District Office
United States
19701 Fairchild Road | |
WARNING LETTER
VIA UPS
SIGNATURE REQUIRED
July 6, 2017
HAF4W(DEN)-17-10-WL
Mr. George Stagnitti, President & CEO
APS Biogroup, Inc.
2235 South Central Ave.
Phoenix, AZ 85004-2909
Dear Mr. Stagnitti:
This is to advise you that the Food and Drug Administration (FDA) reviewed your product labels following an inspection of your facility at 2235 South Central Ave, Phoenix, Arizona, from February 6, 2017, to February 16, 2017. Based on our review, we have determined that the therapeutic claims on your “(b)(4)” and “(b)(4)” establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Further, even if these products were not unapproved new drugs, they would be misbranded foods under section 403 of the Act [21 U.S.C. 343]. Additionally, based on our review of the labels for your “Children’s DiaResQ,” “(b)(4),” “(b)(4),” and “DPS Throat Spray,” we have determined that these products are misbranded under section 403 of the Act [21 U.S.C. 343]. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drugs
Examples of some of the label claims that provide evidence that the following products are intended for use as drugs include:
(b)(4)
• “(b)(4)”
• “[A] combination of natural herbs (b)(4) various pathogens…”
• “[A]bility to combat (b)(4)…”
(b)(4)
• “(b)(4) heavy metals such as mercury and cadmium…”
The “(b)(4)” and “(b)(4)” 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 introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Misbranding Violations
We reviewed the labeling of your “Children’s DiaResQ,” “(b)(4),” “(b)(4),” and “DPS Throat Spray” products and determined that these products are misbranded under section 403 of the Act [21 U.S.C. 343] for the reasons described below. Additionally, even if your “(b)(4)” and “(b)(4)” products did not have therapeutic claims which make them unapproved new drugs, these products would be misbranded foods under section 403 of the Act [21 U.S.C. 343].
1. The “Children’s DiaResQ” product is misbranded under section 403(i)(1) of the Act in that the label does not bear an appropriate common or usual name of the food or an appropriately descriptive term, if there is one, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food as required by 21 CFR 101.3(b).
2. The “(b)(4),” “(b)(4)”, “(b)(4)”, and “(b)(4)” products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example, the “(b)(4)” lists “(b)(4)” and “(b)(4) (patented (b)(4))” as ingredients which are modified names and not the common and usual names of these ingredients. If these ingredients are multi component ingredients, each sub ingredient must also be declared.
Also, the “(b)(4)” and “(b)(4)” products declare “HPMC ((b)(4))” as an “Other Ingredient” but do not list the common or usual name of that ingredient; specifically, HPMC should declared as its scientific name, hydroxypropyl methylcellulose.
In addition, the “(b)(4)” product lists the ingredient “(b)(4)” which is not the common or usual name of an ingredient.
3. The “(b)(4)” 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 incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The serving size is indicated as 2 capsules; however, the directions indicate “may take up to 3 capsules per day”.
4. The “Children’s DiaResQ” product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. Foods, other than infant formula, represented or purported to be specifically for children 1 through 3 years of age shall bear nutrition labeling for those age groups, as required by 21 CFR 101.9(j)(5). The “Children’s DiaResQ” product does not provide nutrition information for children between one (1) year and three (3) years of age. There are specific requirements for children under four (4) years of age and under two (2) years of age in accordance with 21 CFR 101.9(j)(5).
5. Your “DPS Throat Spray” 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 label bears a nutrient content claim, but the product does not meet the requirements to bear the claim. 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.
Specifically, your “DPS Throat Spray” product bears the nutrient content claim “Proline Rich Polypeptides.” FDA has issued a regulation specifying criteria for the use of the nutrient content claim “high” in food labeling, which also applies to synonymous claims such as “rich in” [see 21 CFR 101.54(b)(1)]. This regulation requires a food that bears this claim to contain 20 percent or more of the Reference Daily Intake (RDI) or the Daily Reference Value (DRV) of the nutrient per reference amount customarily consumer (RACC). However, this regulation does not authorize the claim “Proline Rich Polypeptides” because there is no RDI or DRV for “proline.” Therefore, the use of the term “Proline Rich Polypeptides” to characterize the level of “proline” in your “DPS Throat Spray” product causes your product to be misbranded under section 403(r)(1)(A) of the Act.
6. The “(b)(4)” and “DPS Throat Spray” products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the finished product labels fail to declare the major food allergen “milk” as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act, 21 U.S.C. 321(qq), defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
• The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. 343(w)(1)(A)], or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
Specifically, “(b)(4)” and “DPS Throat Spray” products state “Contains Milk Proteins”. “Milk proteins” is not the common or usual name of the food allergen milk.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, such as seizure or injunction.
We offer the following comments:
1. The listing of the trademarked name “(b)(4) within the declared ingredients of the “(b)(4)” product is intervening material in accordance with 21 CFR 101.2(e).
In addition, the ingredient list and the business name and address on this product are not together in one place without intervening material in accordance with 21 CFR 101.2(e).
2. The “Children’s DiaResQ” product’s net weight is not declared in the proper format in accordance with 21 CFR 101.7(s). The net wet is declared as “0.74 OZ (21g)” but does not declare the net weight of the individual packets the multiunit retail package consists of.
3. The nutrition information provided on the “(b)(4)” product appears to not be consistent with the requirements under 21 CFR 101.9. For example, the label declares the serving size as 2 scoops ((b)(4)g) and the directions for use indicate that (b)(4)g makes 12 oz of the beverage. The serving size for beverages is 8oz (240ml); therefore, the reference amount for the powder is the amount required to make the reference amount of the prepared form in accordance with 21 CFR 101.12(c). Also, the declaration for the percentages for vitamins and minerals must be expressed to the nearest 10-percent increments above the 50 percent level. We also note that regulations do not allow for adding nutrients in the Nutrition Facts Label that are not provided under 21 CFR 101.9(c)(8)(ii).
4. The nutrition information provided for the “Children’s DiaResQ” product is not consistent with the requirements under 21 CFR 101.9. The declaration for the percentages for vitamins and minerals must be expressed to the nearest 2-percent increments up to and including the 10 percent level.
5. The “(b)(4)” product label bears the following or similar statement: “Percent Daily Values based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value (DV) is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).
6. The “DPS Throat Spray” fails to present the nutrition information in accordance with 21 CFR 101.36(e).
7. The following disclaimer “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease” appears on the (b)(4) product and is not appropriate to be declared on conventional food products. In accordance with 21 CFR 101.93(b), this disclaimer is required when a dietary supplement bears a statement that is provided for by section 403(r)(6) of the Act, and the manufacturer, packer, or distributor wishes to take advantage of the exemption to section 201(g)(1)(C) of the Act that is provided by compliance with section 403(r)(6) of the Act.
8. The “(b)(4)” product’s declaration of net quantity of contents is not in accordance with 21 CFR 101.7(j)(3).
9. Please note the FDA does not have a regulatory definition for the term “(b)(4)” declared on the “(b)(4)” product’s label.
Within fifteen working days of receipt of this letter, you should notify this office in writing of the specific steps you have taken to correct the violations noted above. You should include in your response documentation and any other useful information that would assist us in evaluating your corrective actions and an explanation of each step being taken to prevent the recurrence of violations. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
If you have any questions regarding this letter, please contact Caroline H. Le, Compliance Officer, at 303-236-3045.
Your written reply should be sent to:
Caroline H. Le
Compliance Officer
US Food & Drug Administration
P.O. Box 25087
Denver, CO 80225-0087
Sincerely,
/S/
LaTonya M. Mitchell
District Director, FDA Denver District
Program Division Director
Office of Human and Animal Foods – Division IV West