Inspections, Compliance, Enforcement, and Criminal Investigations
Liquid Health, Inc. 1/31/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
January 31, 2013
Mr. Alma Mattson, Owner WL# 20-13
Liquid Health, Inc.
25799 Jefferson Ave
Murrieta, CA 92562
Dear Mr. Mattson:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 25799 Jefferson Ave., Murietta, CA from August 7 through August 24, 2012. During the inspection our investigators collected labeling for your products and evaluated the manufacturing of several of your products which you label as dietary supplements, including Attention, Calcium and Magnesium, Diabetic Support, Immune Balance, and Ultra-Antioxidant. Based on our review we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov.
Unapproved New Drugs
Based on our review of your product labeling, including your website www.liquidhealthinc.com, we have determined that your products, Attention, Calcium and Magnesium, Diabetic Support, Immune Balance, and Ultra-Antioxidant, are promoted for conditions that cause the products to be drugs within the meaning of section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The claims in the labeling for these products establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of the claims found on your product labeling include:
- “Attention…For ADHD”
- “Attention is designed to supply nutrients thought to reduce symptoms of ADD/ADHD.”
Calcium and Magnesium
- “Boron [an ingredient in your product]… to staving off osteoporosis.”
- Product name is a disease claim.
- “Intended for use by diabetics, or others looking to stabilize blood sugar levels.”
Immune Balance 365
- “For 365 days resistance from germs & bacteria.”
- “It [Immune Balance]…fights infections…”
- “Ultra Antioxidant… provide[s] a benefit by disrupt[ing] … cancer and other diseases.”
Because these products are not generally recognized as safe and effective for the above referenced conditions and therefore, these products are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 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.
Furthermore, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your products are also misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
Adulterated Dietary Supplements
In addition, even if your products, including those listed above, were not unapproved new and misbranded drugs, they would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulations, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111).
We received your undated written response on September 17, 2012, concerning our investigator’s observations noted on the Form FDA 483, List of Observations, that was issued to you on August 24, 2012. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violation, noted below.
Specifically, during our inspection, our investigators observed the following:
1) Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). For example, your firm did not perform any test or examination to verify the identity of (b)(4), a dietary ingredient which was used in the manufacture of Colloidal Silver, lot number (b)(4).
We have reviewed your response, received September 17, 2012, and find it inadequate. Your firm states you will accept (b)(4) from US manufacturers if stamped appropriately, and that you will verify the identity of (b)(4) obtained from foreign sources. An appropriate identity test must be conducted for all dietary ingredients, regardless of their source. Additionally, it is not clear if the Raw Material Testing Sheet provided with your response referenced retrospective testing of (b)(4) which was used in the manufacture of Colloidal Silver, (b)(4).
2) Your firm failed to establish specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). Furthermore, your firm failed to make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1). Specifically, you did not maintain any records of finished product specifications. During the inspection you claimed that you used your product labeling, which references the amount of dietary ingredients per serving, as your finished product specifications. In addition, you verbally indicated to our investigator that your firm’s current specifications are greater than or equal to the label claim. You indicated during the inspection that your firm would establish product specifications to be (b)(4) of the label claim.
We have reviewed your response, received September 17, 2012, and find it inadequate. Furthermore, your firm admits to not establishing finished product specifications other than those appearing on labeling. We note that you committed during the inspection to establish a specification of (b)(4) of the label claim, but your written response states that you will revise your finished product specifications to include a range of (b)(4) of labeling claims. We also note that in accordance with the requirements related to nutrient declarations in 21 CFR 101.36(b)(2), and 101.36(f) (which cross references 101.9(g)(4)), (b)(4) would not be an appropriate specification and complying with such a specification may render your products misbranded.
3) Your firm failed to verify that your finished batches of the dietary supplements meet your stated product specifications, in accordance with 21 CFR 111.75(c), for the following products:
- Attention, lot (b)(4)
- Hair Loss Supplement, lot (b)(4)
- Complete Multivitamin, lot (b)(4)
- Colloidal Silver, lot (b)(4)
You must determine whether the finished product specifications you establish for identity, purity, strength, and composition and for limits on contamination have been met for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan, or for every finished batch, as required by 21 CFR 111.75(c).
We have reviewed your response, received September 17, 2012, and find it inadequate. You erroneously state that “the standard industry practice and standard is not to do any finished product testing.” Finished product testing is required by 21 CFR 111.75(c).
4) Your quality control personnel failed to reject dietary supplements that did not meet specifications established under 111.70(e), as required by 21 CFR 111.77(a). In addition, your quality control personnel released for distribution batches of dietary supplements that did not meet specifications in violation of 21 CFR 111.123(b)(2). For example, your firm tested finished batches of dietary supplements, Calcium and Magnesium liquid dietary supplement, lot (b)(4) and Vitamin B-12 liquid dietary supplement, lot (b)(4) against the respective labeled declaration per serving. While you do not have written finished product specifications for strength, you stated during the inspection that your specification was greater than or equal to the label value. These finished products did not meet specifications on their labeling; however, your firm's quality control personnel did not reject or approve rework for these batches. These dietary supplement products were released and distributed. Your quality control personnel must not approve and release for distribution any batch of dietary supplement that does not meet all finished product specifications.
We have reviewed your response, received September 17, 2012, and find it inadequate. You have stated that you will establish finished product specifications that are (b)(4) of your labeling claims. You further stated that had you made finished products according to these specifications, then all of the tests that you did would make your products compliant. However, this is not accurate. For example, your Calcium & Magnesium, lot (b)(4) includes the following label claims for vitamin D and L-lysine: 400 iu/serving vitamin D and 100 mg/serving L-lysine. The (b)(4) testing yielded results of 307 IU/serving vitamin D (- 23.25% of the label claim) and 82.4 mg/serving L-lysine (-17.6% of the label claim). Both of these nutrients are outside of the specification that you state have been established.
5) Your firm failed to qualify the suppliers of components, other than dietary ingredients, by establishing the reliability of the suppliers’ certificates of analysis through confirmation of the results of the suppliers’ tests or examinations, before using those components, as required by 21 CFR 111.75(a)(2)(ii)(A), and failed to maintain documentation of how the supplier was qualified, as required by 21 CFR 111.75(a)(2)(ii)(C). Specifically, our investigator found that your firm did not have any supplier qualification records for the suppliers (b)(4) or (b)(4). Your supplier qualification records for the following were incomplete:
We have reviewed your response, received September 17, 2012, and find it inadequate. You promise to qualify all suppliers over the next twelve months; however, this timeframe is not adequate. Pending the qualification of a supplier, you must conduct your own appropriate tests or examinations to confirm the identity of components and determine whether other applicable component specifications are met, in accordance with 21 CFR 111.75(a)(2).Furthermore, aside from your SOP PPC-0008-01, you have provided no evidence that corrections are being made, or that you have taken any actions for products currently in the marketplace while corrections are pending.
6) Your firm failed to report a Serious Adverse Event Report (SAER) for a dietary supplement within the statutory 15 business days, as required under Section 761 of the Act (21 U.S.C. 379aa-1). Specifically, for Consumer Complaint (b)(4), received on 10/28/2011 your firm did not submit a SAER within the required timeframe. The complaint referenced a report from a customer asserting that Liquid Health Complete Multivitamin, lot (b)(4), had a different taste and smell from the same previously purchased product. The complainant continued using the product and later developed a bacterial infection and was put on antibiotics. The complainant alleged that the product was responsible for the infection. Absent the use of antibiotics the complainant could have suffered serious consequences, including hospitalization or death.
We have reviewed your response received September 17, 2012, and find it inadequate. Although you submitted a MEDWATCH Form FDA 3500a on September 13, 2012, this submission was not within the 15 business days from the date your firm received the SAER, as required under section 761 of the Act.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and your products comply with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
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 costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your response should be sent to:
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
Irvine, CA 92612
Refer to the Unique Identification Number (CMS Case # 360899) on all correspondence when replying. If you have any questions about the content of this letter, please contact Dr. William Vitale, Compliance Officer, at 949-608-2919 or Bill.Vitale@FDA.HHS.GOV.
Alonza E. Cruse, Director
Los Angeles District
Patrick Kennelly, Acting Branch Chief
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413
Attn: FDA correspondence