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WARNING LETTER

A1 Top World Products LLC MARCS-CMS 568321 — 10/04/2019

A1 Top World Products LLC - 568321 - 04/10/2019

Product:
Dietary Supplements
Drugs

Recipient:
Recipient Name
Dr. Trung Hoang Pham
Recipient Title
Owner
A1 Top World Products LLC

9822 Bolsa Ave, Ste E
Westminster, CA 92683
United States

Issuing Office:
Division of Human and Animal Food Operations West V

1431 Harbor Bay Parkway
Alameda, CA 94502-7070
United States


WARNING LETTER

 

April 10, 2019

 

Dr. Trung Hoang Pham, Owner

A1 Top World Products, LLC

9822 Bolsa Ave, Ste E

Westminster, CA 92683

 

Dear Dr. Trung Hoang Pham:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 9822 Bolsa Ave, Ste E, Westminster, CA 92683, on September 21 and September 24, 2018. During the inspection, we collected labels for your products. Based on the inspectional findings, a subsequent review of the product labels collected during the inspection, and a subsequent review of your website at the Internet address http://www.phamhoangtrung.com/, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

Unapproved New Drugs

FDA reviewed your website at the Internet address http://www.phamhoangtrung.com/ in March 2019 and has determined that you take orders there for the products Doctor’s Hawaiian Noni Once A Day, Doctor’s Hawaiian Noni for Kids, Doctor’s SuperBone, and Doctor’s SuperFucoidan.   The claims on your website establish that the products are drugs under section 201(g)(1)(B) of 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. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

On the webpage http://www.phamhoangtrung.com/C_1-3_2-325/, the following claims are present and associated with the named products:

  • Drug Supplement for Blood Doctor’s Hawaiian Noni Once A Day… very effective for people with fatigue, dizziness due to anemia.”
  • Drug for Helping Children Eat Well, Be Healthy Doctor’s Hawaiian Noni For Kids…. Very effective for children who lack appetite, have illness or are malnourished.”
  • Drug Supplement for Bones Doctor’s SuperBone includes all the minerals, vitamins, pharmaceutical ingredients, and herbs that provide drug supplements for bones … which prevents the bones from fracturing when falling.”
  • Drug Doctor’s SuperFucoidan … to ‘prevent illness better than treat illness.’” 

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 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.

Adulterated Dietary Supplements

During the September 21 and September 24, 2018 inspection of your facility, our investigators observed the following significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which render your dietary supplement products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Additionally, even if your Doctor’s SuperFucoidan, Doctor’s Hawaiian Noni Once A Day, Doctor’s Hawaiian Noni for Kids, and Doctor’s SuperBone products did not have therapeutic claims which make them unapproved new drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. 

We acknowledge receipt of your written response, dated October 10, 2018, to the observations reported to you on the Form FDA-483, Inspectional Observations, which was issued to you on September 24, 2018.

We understand that you contract with other manufacturers to perform certain operations relating to products that are distributed into interstate commerce under your firm’s name. As a distributor that contracts with another manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)].   Your firm introduces or delivers, or causes the introduction or delivery of, dietary supplements into interstate commerce in its final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.

Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements.[1] The Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)].  Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and/or labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.

The significant violations documented during the inspection include, but are not limited to, the following:

1.    You failed to establish specifications for dietary supplement labels (labeling specifications), as required by 21 CFR 111.70(d). Specifically, during the inspection, you stated that you do not have written label specifications, and you were unable to provide any documentation when requested by our investigator regarding labeling specifications. Once you have established label specifications, you must make and keep records of such specifications, as required by 21 CFR 111.95(b)(1).

We have reviewed your response, dated October 10, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. Your response included a blank document identified as the label specification for your Doctor’s Super Fucoidan Capsules product.

2.    You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distributing operations for your dietary supplement products. Once have you established written procedures for your holding and distributing operations, you must make and keep records of such written procedures, as required by 21 CFR 111.475(b)(1).

 Misbranded Dietary Supplements

Certain of your dietary supplement products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements, as required by 21 CFR Part 101, for the reasons discussed below. Additionally, even if your Doctor’s Hawaiian Noni Once A Day, Doctor’s Hawaiian Noni for Kids, Doctor’s SuperBone, and Doctor’s SuperFucoidan products did not have therapeutic claims which make them unapproved new drugs, your products would be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343] because they also do not comply with the labeling requirements for dietary supplements, as required by 21 CFR Part 101, as follows:

1.    Your Doctor’s Hawaiian Noni Once A Day, Doctor’s Hawaiian Noni for Kids, Doctor’s CholesteroRite, Doctor’s SuperHair, Doctor’s SuperDiet, Doctor’s SuperBone, and Doctor’s SuperFucoidan products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the label fails to list the current name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

2.    Your Doctor’s Hawaiian Noni Once A Dayproduct is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product contains iron, but the labeling fails to bear the following warning statement required under 21 CFR 101.17(e): “WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.”

In addition, your Doctor’s SuperProstate, Doctor’s SuperBone, and Doctor’s SuperSkin products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product labels contain information in two languages but do not repeat all the required information in both languages.

3.    Your Doctor’s Maraton, Doctor’s Super Manpower Energizer, Doctor’s SuperVision, Doctor’s SuperDiet, and Doctor’s SuperProstate product labels are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example:

    • Your Doctor’s Maraton product label declares the dietary ingredient “pentaphyllum” whereas the standardized common name is gynostemma according to the reference Herbs of Commerce.
    • Your Doctor’s Super Manpower Energizer product label declares the dietary ingredient DHEA but this is not the common or usual name for this dietary ingredient.
    • Your Doctor’s SuperVision product label declares the dietary ingredients “galinut” and your Doctor’s SuperProstate product label declares the dietary ingredient “cernilton,” but these are not the common or usual names for these dietary ingredients.
    • Your Doctor’s Maraton and Doctor’s SuperDiet product labels declare the dietary ingredient “cactus” and your Doctor’s Maraton label declares the dietary ingredient “sea weed.” The label must state the standardized common name of the specific genus and species of cactus and seaweed. If these botanical ingredients are not located in Herbs of Commerce, the label must list the Latin binomial in accordance with 21 CFR 101.4(h)(2).

4.    Your Doctor’s Hawaiian Noni Once A Day, Doctor’s SuperHair, Doctor’s SuperBone, Doctor’s Super Fucoidan, Doctor’s SuperVision, Doctor’s Super Manpower Energizer, Doctor’s CholestroRite, Doctor’s Maraton, Doctor’s SuperSkin, and Doctor’s Hawaiian Noni for Kids products are 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 nutrition information on the labeling does not comply with 21 CFR 101.36. For example:

  • Your Doctor’s Hawaiian Noni Once A Day, Doctor’s SuperHair, Doctor’s SuperBone, Doctor’s SuperSkin, Doctor’s Super Fucoidan, and Doctor’s SuperVision product label fails to declare the source of each dietary ingredient as required by 21 CFR 101.36(d).
  • Your Doctor’s Hawaiian Noni Once A Day and Doctor’s SuperVision product labels fail to declare the % Daily Value for selenium. Furthermore, your Doctor’s Flexodin product label fails to list the correct % Daily Value of 40% for vitamin B-5 (pantothenic acid) based on the quantitative amount per serving.
  • Your Doctor’s Hawaiian Noni for Kids, Doctor’s SuperHair, and Doctor’s Super Manpower Energizer product labels list thiamin as “vitamin B1” or “vitamin B-1” and riboflavin as “vitamin B2” or “vitamin B-2.” While these alternative names are acceptable synonyms for the listed vitamins, in accordance with 21 CFR 101.36(b)(2)(i)(B)(2), the synonym must parenthetically follow the name of the dietary ingredient. Your Doctor’s Hawaiian Noni for Kids and Doctor’s Super Manpower Energizer product labels declare the dietary ingredient “vitamin B3” or “vitamin B-3,” your Doctor’s Flexodin label declares “vitamin B-5,” and your Doctor’s SuperFucoidan label declares “vitamin D3” which is not the nomenclature or synonym specified for niacin, pantothenic acid, or vitamin D, respectively, in 21 CFR 101.9 or 101.36(b)(2)(i)(B).
  • Your Doctor’s CholestroRite product label declares calcium pyruvate and chromium picolinate. The quantitative amounts by weight shall represent the weight of the dietary ingredient rather than the weight of the source of the dietary ingredient (e.g., the weight of calcium rather than that of calcium pyruvate) [21 CFR 101.36(b)(2)(ii)]. The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words "as" or "from", e.g., "Calcium (as calcium pyruvate)” [21 CFR 101.36(d)].
  • Your Doctor’s Noni for Kids product’s Supplement Facts label fails to list the serving size for each of the age groups indicated on the label which include 1 tablet a day for under 4 years of age, 2 tablets a day for 4 to 8 years of age, and 3 tablets a day for 8 years of age or older. If the product is for persons within more than one group, the quantitative amount and percent of Daily Value for each group shall be presented in separate columns in accordance with 21 CFR 101.36(b)(2)(iii)(E).
  • Your Doctor’s Maraton product label declares vitamin A with an amount of <1% of the Daily Value and your Doctor’s Hawaiian Noni Once A Day label declares chloride with an amount of 1%. 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).
  • Your Doctor’s Maraton product label declares vitamin D with a percent Daily Value of 6.25%, your Doctor’s Flexodin label declares magnesium with a percent Daily Value of 2.5%, and your Doctor’s Hawaiian Noni Once A Day label declares phosphorus with a percent Daily Value of 7.7%. The percentages based on RDI's and on DRV's shall be expressed to the nearest whole percent in accordance with 21 CFR 101.36(b)(2)(iii)(C).
  • Your Doctor’s Maraton, Doctor’s Flexodin, and Doctor’s Hawaiian Noni Once A Day product labels fail to list the (b)(2)-dietary ingredients in the correct order in accordance with 21 CFR 101.36(b)(2)(i)(B).
  • Your product labels are not consistent in using a heavy bar below the (b)(2)-dietary ingredients or below the (b)(3)-dietary ingredients as required by 21 CFR 101.36(e)(6).

5.    Your Doctor’s Hawaiian Noni & Ginkgo, Doctor’s CholesteroRite, Doctor’s Maraton, Doctor’s SuperVision, Doctor’s SuperProstate, and Doctor’s SuperFucoidan products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the labels are 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:

  • The directions of use for your Doctor’s Hawaiian Noni & Ginkgo, Doctor’s Maraton, Doctor’s SuperVision, and Doctor’s SuperProstate product suggest the consumer take 1 to 2 capsules daily but the serving size lists 1 capsule. The serving size listed should be the maximum amount of product per eating occasion.
  • The directions of use for your Doctor’s CholesteroRite product suggest the consumer take 2 or 3 capsules daily but the serving size lists 1 capsule. The serving size listed should be the maximum amount of product per eating occasion.
  • The directions of use for your Doctor’s SuperFucoidan product suggest the consumer take 1 to 2 capsules two to three times per day but the serving size lists 1 capsule. The serving size listed should be the maximum amount of product per eating occasion; thus, the serving size should be 2 capsules.

6.    Your Doctor’s Hawaiian Noni & Ginkgo, Doctor’s Hawaiian Noni Once A Day, Doctor’s Hawaiian Noni for Kids, Doctor’s CholesteroRite, Doctor’s Super Manpower Energizer, Doctor’s Maraton, Doctor’s SuperHair, Doctor’s SuperVision, Doctor’s SuperBone, Doctor’s SuperSkin, Doctor’s Flexodin, Doctor’s SuperLiver, Doctor’s SuperDiet, Doctor’s SuperFucoidan, and Doctor’s SuperProstate products are misbranded within the meaning of Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)], in that the labels fail 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:

  • Your Doctor’s Hawaiian Noni & Ginkgo product label fails to include the part of the plant from which Morinda citrifolia is derived.
  • Your Doctor’s Hawaiian Noni Once A Day, Doctor’s SuperBone, and Doctor’s Hawaiian Noni for Kids product labels fail to include the part of the plant from which noni is derived.
  • Your Doctor’s CholesteroRite product label fails to include the part of the plant from which noni, garlic, and green tea are derived;
  • Your Doctor’s Super Manpower Energizer product label fails to include the part of the plant from which noni, damiana, saw palmetto, Panax ginseng, Ginkgo biloba, and stinging nettle are derived.
  • Your Doctor’s Maraton product label fails to include the part of the plant from which Panax ginseng, garlic, aloe vera, green tea, turmeric, Ginkgo biloba, milk thistle, echinacea, goldenseal, ginger, licorice, cinnamon, schisandra, dandelion, fo-ti, noni, astragalus, pentaphyllum, and stinging nettle are derived.
  • Your Doctor’s SuperHair product label fails to include the part of the plant from which horsetail, fo-ti, noni, and stinging needle are derived.
  • Your Doctor’s SuperVision product label fails to include the part of the plant from which berieric myrobalan, eyebright, and noni are derived.
  • Your Doctor’s SuperProstate product label fails to include the part of the plant from which saw palmetto, licorice, cernilton, pPygeum africanum, stinging nettle, and noni are derived.
  • Your Doctor’s SuperSkin product label fails to include the part of the plant from which turmeric is derived.
  • Your Doctor’s SuperFucoidan product label fails to include the part of the plant from which noni, green tea, aloe vera, and turmeric are derived.
  • Your Doctor’s Flexodin product label fails to include the part of the plant from which noni, turmeric, Boswellia serrata, and Ginkgo biloba are derived.
  • Your Doctor’s SuperLiver product label fails to include the part of the plant from which noni, turmeric, aloe vera, milk thistle, artichoke, licorice, and ginger are derived. 

7.    Your Doctor’s SuperSkin, Doctor’s Super Manpower Energizer, Doctor’s SuperHair, Doctor’s SuperVision, Doctor’s SuperProstate, Doctor’s SuperLiver, and Doctor’s SuperBone products are misbranded within the meaning of Section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] because the labels make structure/function claims as part of the product name but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b)-(c).

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 legal action without further notice, including, without limitation, seizure and injunction.

We also offer the following comments:

1.    The statement of identity of “Dietary Supplement” regarding your products is not presented in bold type on the principal display panel and in a size reasonably related to the most prominent printed matter on such panel in accordance with 21 CFR 101.3(d).

2.    The information panel on your Doctor’s SuperBone product label includes ingredient information intermingled with information that is considered intervening material. An example of intervening material is the listing of the trademarked name “Sylox” within the ingredients statement. All information appearing on the information panel of the product label must appear in one place without other intervening material in accordance with 21 CFR 101.2(e).

3.    Your Doctor’s SuperBone product label lists non-dietary ingredients within the Supplement Facts label. These “Ingredients” must be listed outside and directly below the Supplement Facts label in accordance with 21 CFR 101.4(g).

4.    Your Doctor’s Hawaiian Noni for Kids product label fails to follow the numerical value for the % Daily Value with the symbol for percent (i.e., %) as required by 21 CFR 101.36(b)(2)(iii)(B).

5.    Your Doctor’s SuperProstate product label bears the column heading “RDA%”, whereas the acceptable heading name is %DV or alternatives provided in 21 CFR 101.36(b)(2)(iii)(A).

6.    Your Doctor’s Hawaiian Noni & Ginkgo product label list the ingredients as “inactive ingredients.” The proper way of listing ingredients is to identify them as “other ingredients” or “ingredients” in accordance with 21 CFR 101.4(g).

7.    Your Doctor’s SuperVision product label declares the dietary ingredient “berieric myrobalan.” If your intent was to list “belleric myrobalan,” the word is misspelled. Your Doctor’s Hawaiian Noni Once A Day product label misspells selenium and your Doctor’s SuperProstate product label misspells copper.  

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

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 re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified a noncompliance materially related to food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expense incurred in connection with FDA’s arranging, conducting and evaluating the results of the re-inspection assessing and collecting the re-inspection fees [21 U.S.C § 379j-31(a)(2)(B)]. 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 re-inspection-related cost.

Please send your reply to the Food and Drug Administration, Attention:

Sergio Chavez

Director of Compliance

1431 Harbor Bay Parkway

Alameda, CA 94502

Please reference Case number: 568321

If you have questions regarding this letter, please contact Tammy Hancock at 510-337-2900 ext. 103.

 

Sincerely Yours,

/S/ 

Darla R. Bracy

Director of HAF West Division 5

 


[1] See United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act).