Inspections, Compliance, Enforcement, and Criminal Investigations

New Horizon Nutraceuticals LLC 7/22/16

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390

 

WARNING LETTER
16-PHI-09
 
 
VIA UNITED PARCEL SERVICE
 
July 22, 2016
 
Mr. Robert C. Wiscount, Co-Owner
New Horizon Nutraceuticals, LLC
578 Rosedale Road
Suite 20
Kennett Square, PA 19348
 
Dear Mr. Wiscount:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 578 Rosedale Road, Kennett Square, Pennsylvania, from January 26, 2016 through February 8, 2016. Based on our inspection, we found serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)], in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. 
 
Additionally, based on our review of your products’ labeling collected during this inspection, we found serious violations of section 403 and 505(a) of the Act [21 U.S.C. §§ 343 and 355(a)] and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR part 101. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
The significant violations documented during the inspection include, but are not limited to, the following:
 
Unapproved New Drug
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your product label for One World Whey Protein Power Food following an inspection of your facility at 578 Rosedale Road, Kennett Square, Pennsylvania between January 26, 2016 through February 8, 2016. The claims on your product label establish that the product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the claims on your product label that provide evidence that your product is intended for use as a drug include:
 
From the One World Whey Protein Power Food product label:
  • “Glutathione works to eliminate mercury, heavy metals, and virtually all toxins. It also neutralizes free radicals, thereby stopping cell damage and inflammation.”
  • “[S]topping…inflammation” 
  • (testimonial) “I had been suffering from chronic pain…After 3 weeks on One World Whey, the pain in my feet reduced by 50%, and the overall pain in my body reduced significantly…the pain reduced significantly throughout my body…I’d highly recommend One World Whey to anyone dealing with chronic pain due to inflammation…”
The product is not generally recognized as safe and effective for the above referenced uses and, therefore, the “One World Whey Protein Power Food” dietary supplement product is a new drug 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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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.
 
Dietary Supplement CGMP Violations
 
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(l) of the Act [21 U.S.C. § 342(g)(l)], in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements. Additionally, even if your “One World Whey Protein Power Food” product were not an unapproved new drug, it would be an adulterated dietary supplement under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]:
 
1.    You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, during our inspection, you informed our investigator that you do not conduct testing to verify the identity of your dietary ingredients, due to financial strain of third party laboratory testing.
 
2.    Your master manufacturing records (MMRs) failed to identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in your MMR, as required by 21 CFR 111.205(b)(1).  Specifically, your MMR for Dioxyme BCCA Blue Raz failed to include the following information:
 
a.  The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label, as required by 21 CFR 111.210(d);
 
b.  A statement of any intentional overage amount of a dietary ingredient, as required by 21 CFR 111.210(e);
 
c.  A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made, as required by 21 CFR 111.210(f);
 
d.  A representative label, or a cross-reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g);
 
e.  Written instructions, including specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.210(h)(1);
           
f.  Written procedures for sampling and a cross-reference to procedures for tests or examinations, as required by 21 CFR 111.210(h)(2);
 
g.  Written instructions, including specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.210(h)(3);
 
h.  Special notations and precautions to be followed, as required by 21 CFR 111.210(h)(4);
 
i.  Corrective action plans for use when a specification is not met, as required by 21 CFR 111.210(h)(5).
 
Once you have identified specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in your MMR, you must establish controls and procedures to ensure that each batch of dietary supplement that you manufacture meets the specifications identified, as required by 21 CFR 111.205(b)(2). 
 
3.     Your batch production record (BPR) failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). For example, the BPR for your One World Whey Protein Power Food, lot number (b)(4), did not contain the following information, as required in 21 CFR 111.260:
 
a.  The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or cross reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)];
 
b.  A statement of actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)];
 
c.  The actual results obtained during any monitoring operation [21 CFR 111.260(g)];
 
d.  Documentation, at the time of performance, of the manufacture of each batch [21 CFR 111.260(j)], including;
 
i. The date on which each step of the master manufacturing record was performed [21 CFR 111.260(j)(1)];
 
ii. The initials of the person performing each step, including weighing or measuring each component used in a batch [21 CFR 111.260(j)(2)(i)], the initials of the person responsible for verifying the weight or measurement each component used in a batch [21 CFR 111.260(j)(2)(ii)], the initials of the person responsible for adding the component to the batch [21 CFR111.260(j)(2)(iii)], and the initials of the person responsible for verifying the addition to the batch [21 CFR111.260(j)(2)(iv)];
 
e.  An actual or representative label, or a cross reference to the physical location of the actual or representative label specified in the MMR [21 CFR 111.260(k)(2)];
 
f.  Documentation at the time of performance that the quality control reviewed the batch production record; approved or rejected any reprocessing or repackaging; approved and released, or rejected, the batch for distribution, including any reprocessed batch; and approved and released or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement, as required by [21 CFR 111.260(l)(1)–(4)].
 
4.    You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, the quality control personnel failed to perform the following quality control operations:
 
a.  The quality control personnel failed to approve or reject all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). For example, your firm’s (b)(4) were not signed and approved. In addition, you stated to our investigator this SOP have not been implemented.
 
b.  The quality control personnel failed to conduct a material review and make a disposition decision when there was an unanticipated occurrence during the manufacturing operations that adulterates or may lead to adulteration of the component, dietary supplement, or packaging, or could lead to the use of a label not specified in the master manufacturing record, as required by 21 CFR 111.113(a)(3). For example, Dioxyme BCCA Blue Raz, lot number (b)(4), was reworked as additional ingredients were added, but your quality control unit did not perform a material review.
 
5.    You failed to maintain, clean, and sanitize, as necessary, all equipment, utensils, and any other contact surfaces used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.27(d). Specifically, a review of your records shows products containing allergen ingredients being manufactured and packaged on shared equipment on the same day as non-allergen products, but you have no documentation of cleaning between each blend.  
 
a. On January 8, 2016, you manufactured and packaged Mr. Potts Honey BBQ (whey based protein powder for potato chips), lot (b)(4); followed by Dioxyme BCAA Blue Raz (powdered amino acid supplement), lot (b)(4); followed by Mr. Potts Cheddar Cheese (whey-based protein powder for potato chips), lot (b)(4). According to the ingredient list, Mr. Potts Honey BBQ and Mr. Potts Cheddar Cheese contain whey-based protein powder, which contains the milk allergen. However, your Dioxyme BCAA Blue Raz, which was manufactured in between the Mr. Potts Honey BBQ and Mr. Potts Cheddar Cheese, whey based protein, does not. Your records fail to document any cleaning and/or sanitizing of the equipment between product blends.
 
b. A review of your filler log documents that, on June 1, 2015, you filled Carolina Sports Cookies & Cream (whey protein supplement), lot (b)(4), from 10:05 to 12:21; followed by your Elite Series Premium Whey Vanilla Ice Cream dietary supplement product, lot (b)(4), from 2:20 – 3:00. According to the ingredient list, the Carolina Sports Cookies & Cream contains (b)(4), which contains the wheat allergen. However, the Elite Series Premium Whey Vanilla Ice Cream dietary supplement product does not. You failed to produce any documentation of cleaning and/or sanitizing to prevent cross contamination of the above products.
 
6.    You failed to establish and follow written procedures for fulfilling the requirements for equipment and utensils, in accordance with 21 CFR 111.25. Specifically, you failed to establish and follow written procedures for:
 
a.  Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement [21 CFR 111.25(a)];
 
b.  Calibrating, inspecting, and checking automated, mechanical, and electronic equipment [21 CFR 111.25(b)].  
 
Your firm failed to have written procedures and maintenance records for the calibration, inspection, and checking of equipment, including automated scales and (b)(4) fillers used in the manufacture of your firm’s dietary supplement products.
 
7.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553.  Specifically, you have no written procedures for the review and investigation of product complaints, nor do you have records documenting the complaints you have received, your response, or any investigation which may have been performed. Once you establish the necessary written procedures, you must make and keep records for the review and investigation of product complaints, in accordance with 21 CFR 111.570. 
 
8.    You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have not established written procedures for returned dietary supplements relating to any of the dietary supplement products you distribute. Once you establish such written procedures, you must make and keep records of the dietary supplements that are returned and the disposition of those products, as required by 21 CFR 111.535(b).
 
Misbranded Dietary Supplements
 
Even if the “One World Whey Protein Power Food” product was not an unapproved new drug, it would still be a misbranded dietary supplement under section 403 of the Act [21 U.S.C. § 343] because the product does not comply with the labeling requirements for dietary supplements. Further, the “Elite Series Premium Whey Vanilla Ice Cream” and “Dioxyme BCAA 6-3-3 Blue Razz” dietary supplement products are also misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343] for the reasons discussed below. The inspection revealed the following violations of labeling requirements for dietary supplements:
 
1.    The “Elite Series Premium Whey Vanilla Ice Cream” dietary supplement product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. 343(y)], in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The label for this product does not include a complete address or phone number.
 
2.    The “Elite Series Premium Whey Vanilla Ice Cream” and “One World Whey Protein Power Food” dietary supplement 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 nutrition information does not comply with 21 CFR 101.36.
  • Specifically, the “Elite Series Premium Whey Vanilla Ice Cream” dietary supplement product does not declare “Vitamin C” and “Iron” using the unit of measure as required by 21 CFR 101.36(b)(2)(ii)(B) given in 21 CFR 101.9(c)(8)(iv). Also, the “Elite Series Premium Whey Vanilla Ice Cream” dietary supplement product bears a % Daily Value for total carbohydrate which is not correct based on the listed amount.
  • Specifically, the “One World Whey Protein Power Food” and “Elite Series Premium Whey Vanilla Ice Cream” dietary supplement products bear % Daily Values of <2% for some of the vitamin and mineral dietary ingredients. Any 21 CFR 101.36(b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in 21 CFR 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2% of the RDI for vitamins and minerals), in accordance with 21 CFR 101.36(b)(2)(i).
  • The “Dioxyme BCAA 6-3-3 Blue Razz” dietary supplement product bears the statement “Percent Daily Values are based on a 2,000 calorie diet. Your Daily Values may be higher or lower depending on your calorie needs.” 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). As none of those dietary ingredients are present on the label, the statement is not permitted. 
3.    The “One World Whey Protein Power Food” dietary supplement product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], in that it fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.  Specifically, these products fail to list the city, state, and zip code of the place of business, as required by 21 CFR 101.5(d).
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or 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. 
 
In addition to the above violations, we have the following comments:
 
You presented our investigator with a proposed revised labeling for the “Elite Series Premium Whey Vanilla Ice Cream” dietary supplement product which will be used for future product manufacturing. Please be advised similar deficiencies were observed in this proposed revised label as were with the “Elite Series Premium Whey Vanilla Ice Cream” labeling referred to above. In addition, the proposed revised labeling for the “Elite Series Premium Whey Vanilla Ice Cream” dietary supplement product also fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.
 
Additional deficiencies observed with the “One World Whey Protein Power Food” dietary supplement product regarding 21 CFR 101.36(b)(2)(ii)(A) and 21 CFR 101.36(b)(2)(ii)(B) include the following: 
  • “Calories” and “Calories from Fat” are not declared to the nearest 10-calorie increment in foods above 50 calories per serving as required by 21 CFR 101.9(c)(1);
  • “Total Fat” and “Saturated Fat” is not declared to the nearest gram increment above 5 grams as required by 21 CFR 101.9(c)(2);
  • “Cholesterol” is not declared to the nearest 5 milligram increment as required by 21 CFR 101.9(c)(3);
  • “Sodium” is not declared to the nearest five milligram increment when the serving contains 5 to 140 milligrams as required by 21 CFR 101.9(c)(4);
  • “Carbohydrates,” “Dietary Fiber,” and “Sugars” are not declared to the nearest gram as required by 21 CFR 101.9(c)(6);
  • The percent of Daily Value for “Total Fat,” “Carbohydrates,”, and “Sodium” are not expressed to the nearest whole percent as required by 21 CFR 101.36(b)(1)(iii)(C).
It was observed the “Dioxyme BCAA 6-3-3 Blue Razz” dietary supplement product failed to declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.105. In accordance with 21 CFR 101.105(b)(1), statements of weight shall be in terms of avoirdupois pound and ounce. Specifically, your “Dioxyme BCAA 6-3-3 Blue Razz” dietary supplement product declares the statement of weight as “560 grams.”
 
The “Elite Series Premium Whey Vanilla Ice Cream” dietary supplement product uses “vanilla ice cream” in the product description. In order not to confuse this with the conventional food, this should be identified as “flavor” (artificial and/or natural), in accordance with 21 CFR 101.22(i).
 
The “Elite Series Premium Whey Vanilla Ice Cream” fails to declare the correct number of servings per container in accordance with 21 CFR 101.36(b)(1)(ii).   The product states the servings per container as 43, although based on the net quantity of contents and serving size, the product contains 45 servings per container.
 
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 documentations. 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.
 
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.
 
Your written response should be sent to Robin M. Rivers, Compliance Officer, at the address noted above. If you have any questions concerning this letter, please contact Ms. Rivers (215) 717-3076.
 
 
Sincerely,
/S/ 
Anne E. Johnson
District Director
Philadelphia District Office
 
 
 
cc:  Mr. Robert Lawrence
       New Horizon Nutraceuticals, LLC
       578 Rosedale Road
       Suite 20
       Kennett Square, PA 19348
 
       Pennsylvania State Department of Agriculture
       Bureau of Food Safety and Laboratory Services
       2301 North Cameron Street
       Harrisburg, PA 17110-9408  
       Attention: Dr. Lydia Johnson, Director 
 

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