The U.S. Food and Drug Administration conducted an inspection of your facility, located at 18538 142nd Avenue NE, Woodinville, Washington, on October 15, 2019, through November 8, 2019. Based on the inspectional findings and a subsequent review of your product labels collected during the inspection, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at
www.fda.gov
.
Adulterated Dietary Supplements:
Based on our inspection, we have identified serious violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations (CFR), 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 Act [21 U.S.C. § 342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
We received emailed correspondence from your consultant dated December 2, 2019, December 20, 2019, January 17, 2020, February 18, 2020, and March 17, 2020, submitted in response to the Form FDA 483, Inspectional Observations, issued to you on November 8, 2019. The response letters discussed corrective actions that your firm has undertaken, as well as proposed timelines for the completion of corrective actions currently in progress. We address your responses below.
The significant violations documented during the inspection include, but are not limited to, the following:
You failed to review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury, as required by 21 CFR 111.560(a). Specifically, during our inspection, a review of product complaints found that you failed to follow your procedures to investigate product complaints related to adverse events, including a complaint received on April 26, 2018, reporting burning of mouths and throats; a complaint received on January 10, 2019, reporting “customers” experiencing nausea, stomach aches, headaches, and some rashes; and another complaint from January 10, 2019, reporting an “allergic” reaction, in order to identify root cause.
Your January 17, 2020 response provided revised procedures for product complaints and adverse event reporting, as well as a record of training provided regarding these procedures. We will verify your implementation of the revised procedures for product complaints and adverse event reporting during our next inspection. However, based on the documentation you provided in your March 17, 2020 response, we have on-going concerns with your review and investigation of product complaints your firm receives. Specifically, you included documentation of a Product Complaint Form F4010-A for the complaints you received on April 26, 2018, January 10, 2019, and January 10, 2019 which are referenced in above, respectively.
Each of the Forms F-4010A for these three complaints have it noted that the complaints are not valid, and that an investigation is only required when a complaint is valid. These complaint forms lack the investigation details to determine how the safety risk of the products were assessed. According to the procedure in your response, a Corrective and Preventative Action (CAPA) is required to address root causes of complaints, but no CAPA appears to have been opened for these three complaints. In addition, the Food Safety Risk decision is circled as “NO” for each of the complaints, but all three complaints involved adverse events.
Misbranded Dietary Supplements:
In addition, your Cocktail Liposomal, Neem Synergy, and Matrix Electrolyte Powder products are misbranded dietary supplements under 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 101 as follows:
1. Your Cocktail Liposomal product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the specific species of shellfish and fish allergen sources as required by section 403(w) 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, your Cocktail Liposomal product label contains the statement “Allergen statement…**LipoSorb is derived from soy lecithin. Third party testing shows no detectable amounts of soy…”. Although the proprietary blend in the product’s Supplement Facts label declares “Phosphatidyl Choline (from Soy Lecithin),” the Contains statement is not in the required format. If present, the Contain statement should be presented as described above, with soy being declared as the food source of the major allergen. In addition, the finished product description sheet provided to our investigator states the product formulation consists of (b)(4)% “LipoSorb (Phosphatidyl Choline from purified Soy Lecithin).”. Also, the webpage for this productat www.biopureus.com states “Contains Soy.” The amount of a soy-based ingredient listed in this product specification document and the Contains statement on the product webpage appears to require the Contains statement in the required format.
2. Your Neem Synergy and Cocktail Liposomal 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, those botanical dietary ingredients that identify the part of the plant as “aerial parts” fail to specify the exact aerial parts.
3. Your Cocktail Liposomal and Matrix Electrolyte Powder 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:
a. Your Cocktail Liposomal product label declares the (b)(2)-dietary ingredient vitamin E as a component of a proprietary blend. Any (b)(2)-dietary ingredients contained in a proprietary blend shall be declared in accordance with 21 CFR 101.36(b)(2) [21 CFR 101.36(c)(1)].
b. Your Cocktail Liposomal product label declares water and ethanol as components of the proprietary blend. Water and ethanol are solvents; thus, they cannot be declared as dietary ingredients in the Supplement Facts label. Furthermore, the label declares glycerine as a dietary ingredient in the proprietary blend, but this is not a dietary ingredient and must instead be listed in the “Other Ingredients” list as required by 21 CFR 101.4(g).
c. Your Matrix Electrolyte Powder product label fails to list the (b)(2)-dietary ingredients in the order prescribed in 21 CFR 101.36(b)(2)(i).
4. Your Neem Synergy product is misbranded within the meaning of section 403(i)(2) of the Act 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:
a. The product label declares the dietary ingredient gudduchi, but that is not the standardized common name as listed in the reference Herbs of Commerce.
b. It appears several ingredients are extracts per the statements “CO2 Full Spectrum Extract” and “PSE Post Supercritical Hydro Ethenolic Extract” on the label, but the Supplement Facts label fails to state these ingredients are extracts.
c. The product label declares black pepper with the Latin binomial name “Piper longum.” The Latin binomial name for black pepper is Piper nigrum. Piper longum is the Latin binomial name for long pepper. The label must clearly state whether the actual dietary ingredient in the product is black pepper (Piper nigrum) or long pepper (Piper longum).
5. Your Matrix Electrolyte Powder is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. For example, the product label fails to state the net weight in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1).
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 the Act and FDA’s implementing 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 of violative products and/or injunction.
