Inspections, Compliance, Enforcement, and Criminal Investigations

Nutrishop dba Natural Generation Nutrition 2/24/17

 

  

Black HHS-Blue FDA Logo

 

 

 
New Jersey District Office
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054 

 

February 24, 2017 
 
WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
              
 
Mr. Joseph D’Arpa, Owner
Natural Generation Nutrition                                              17-NWJ-05
2130 Highway 35, Suite 224
Sea Girt, NJ 08750
  
 
Dear Mr. D’Arpa:
 
This letter concerns your product “NGN NATURAL generation nutrition ZXT2,” which is labeled and/or offered for sale as a dietary supplement. The Supplement Facts panel on “NGN NATURAL generation nutrition ZXT2” declares Acacia rigidula as a dietary ingredient. This ingredient is also called, among other names, Vachellia rigidula, chaparro prieto, and blackbrush, and will be referred to in the rest of this letter as A. rigidula.
 
As an herb or other botanical, A. rigidula is a dietary ingredient under section 201(ff)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)(C)]. Further, as a dietary ingredient that was not marketed in the United States before October 15, 1994, A. rigidula is a “new dietary ingredient” under section 413(d) of the Act [21 U.S.C. § 350b(d)]. Under section 413 of the Act [21 U.S.C. § 350b], a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. § 342(f)] unless it meets one of two requirements:
 
1.    The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
 
2.    There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
 
To the best of FDA’s knowledge, there is no information demonstrating that A. rigidula was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. In the absence of such information, A. rigidula is subject to the notification requirement in section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6. Because the required notification has not been submitted, your product is adulterated under sections 402(f)(1)(B) and 413(a) of the Act [21 U.S.C. §§ 342(f)(1)(B) and 350b(a)].
 
Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that A. rigidula, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, “NGN NATURAL generation nutrition ZXT2” is adulterated under sections 402(f)(1)(B) and 413(a) of the Act [21 U.S.C. §§ 342(f)(1)(B) and 350b(a)] because it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such product into interstate commerce is prohibited under section 301(a) and (v) of the Act [21 U.S.C. § 331(a) and (v)]. To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that A. rigidula will reasonably be expected to be safe when used as a dietary ingredient.
 
Misbranded Dietary Supplements
 
1.    Your “Zi Xiu Tang Beauty Face & Figure Capsule” product is misbranded within the meaning of section 403(i)(1) and 403(s)(2)(B) of the Act [21 U.S.C. § 343(i)(1) and 343(s)(2)(B)] because it does not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
 
2.    Your “Zi Xiu Tang Beauty Face & Figure Capsule” 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 product label fails to bear nutrition labeling (“Supplement Facts” label) in accordance with 21 CFR 101.36. For example,
 
a.  The product label does not present the (b)(2)- and (b)(3)-dietary ingredients in the correct order and in the format required in 21 CFR 101.36. For example, “Dietary Fiber” ((b)(2)-dietary ingredient) should precede the listing of (b)(3)-dietary ingredients.
 
b.  The product labeling fails to list within the Supplement Facts label, the quantitative amount by weight per serving of each dietary ingredient in accordance with 21 CFR 101.36(b)(2) and (b)(3).
 
3.    Your “Zi Xiu Tang Beauty Face & Figure Capsule” 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 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 or foreign characters, 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.
 
4.    Your “NGN NATURAL generation nutrition ZXT2” and “Zi Xiu Tang Beauty Face & Figure Capsule” products are misbranded within the meaning of section 403(q)(1)(A) [21 U.S.C. § 343(q)(1)(A)] of the Act 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. For example,
 
a.  The suggested use for “Zi Xiu Tang Beauty Face & Figure Capsule” indicates one to two capsules each time but the serving size lists 1 capsule. The serving size listed should be 2 capsules.
 
b.  The suggested use for “NGN NATURAL generation nutrition ZXT2” indicates “Advanced users may consume 2 capsules in the morning.” but the serving size lists 1 capsule. The serving size listed should be 2 capsules.
 
5.    Your “NGN NATURAL generation nutrition ZXT2” and “Zi Xiu Tang Beauty Face & Figure Capsule” products are 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). For example,
 
a.  The “NGN NATURAL generation nutrition ZXT2” product label declares “Senna,” but you do not declare the part of the plant from which it is derived from, as required by 21 CFR 101.4(h)(1).
 
b.  The “Zi Xiu Tang Beauty Face & Figure Capsule” product label declares “Chinese Yam,” but you do not declare the part of the plant from which it is derived from, as required by 21 CFR 101.4(h)(1).
 
6.    Your “NGN NATURAL generation nutrition ZXT2” and “Zi Xiu Tang Beauty Face & Figure Capsule” products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] because the labels do not list the name and place of business of the manufacturer, packer, or distributor, as required by with 21 CFR 101.5.
 
7.    Your “NGN NATURAL generation nutrition ZXT2” and “Zi Xiu Tang Beauty Face & Figure Capsule” products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because each product is fabricated from two or more ingredients and each label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. For example, the term “vitamins” is not the common or usual name of an ingredient. Furthermore, “Dioscoreae” is not the standardized common name as noted in Herbs of Commerce.
 
It is also a violation of section 301(a) of the Act (21 U.S.C. 331(a)) to introduce or deliver for introduction into interstate commerce any food, including a dietary supplement, that is misbranded.
 
This letter is not intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. 
 
We request that you take prompt action to correct the violations cited above, as well as any other violations associated with your products. We also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered.
 
It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to correct the violations cited above, including, but not limited to, ceasing the marketing of the product “NGN NATURAL generation nutrition ZXT2” containing A. rigidula, as well as any other dietary supplement products you market that contain A. rigidula, could result in enforcement action by FDA without further notice. Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334].
 
We offer the following labeling comments:
 
For the “Zi Xiu Tang Beauty Face & Figure Capsule” product label:
  • The “Serving Size” must be placed under the heading “Supplement Facts” and aligned on the left side of the Supplement Facts label.
  • The “Servings Per Container” must be placed under the subheading “Serving size” and aligned on the left side of the Supplement Facts label.
  • Although the product labeling contains the FDA disclaimer statement as required by 21 CFR 101.93, the disclaimer is not linked to text through the use of a symbol, per 21 CFR 101.93(d).
  • Your product label declares a “Main Ingredients” list which fails to list all ingredients contained in the product, as noted in the Supplement facts label and Other Ingredients section of the label. Furthermore, the declaration of “Dietary Fiber” as an ingredient in the “Main Ingredients” list is not the common or usual name of an ingredient.  
For the “NGN NATURAL generation nutrition ZXT2” product label:
  • The product label bears the statement “Percent Daily Values are based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value 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). None of those dietary ingredients is present on the label, so the statement is not permitted.
  • Although there is a symbol preceding the disclaimer statement “These statements have not been…” the same symbol does not appear elsewhere on the label in accordance with 21 CFR 101.93(d).
  • The product labels fail to place a heavy bar between the (b)(2) and (b)(3) dietary ingredients, and below the last (b)(3)-dietary ingredient in accordance with 21 CFR 101.36(e)(6).  
We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of each step taken to ensure that similar violations do not arise, as well as documentation to support your response.
 
Your written reply should be directed to Robert J. Maffei, Compliance Officer, United States Food and Drug Administration, New Jersey District Office, 10 Waterview Blvd., Parsippany, NJ 07054. If you have any questions, please contact Mr. Maffei at 973-331-4906.
  
 
Sincerely,
/S/ 
Craig W. Swanson
Acting District Director
New Jersey District

 

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