Inspections, Compliance, Enforcement, and Criminal Investigations

AMS Health Sciences 7/25/14

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

July 25, 2014
 

Ref: 2014-DAL-WL-14
 

WARNING LETTER

UPS OVERNIGHT MAIL

Dhamendra Lachman, Owner and COO
AMS Health Sciences, LLC
711 NE 39th Street
Oklahoma City, OK 73105-7219
 

Dear Mr. Lachman:

The U.S. Food and Drug Administration (FDA or we) inspected your facility, located at 711 NE 39th Street, Oklahoma City, OK, from November 19, 2013, through December 17, 2013. Based on our inspection and subsequent review of your product labeling collected during the inspection as well as your firm's website, we found 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 home page at www.fda.gov.

The inspection and our review of your website and product labeling collected during the inspection revealed the following significant violations:

Unapproved New Drug Violations

We have reviewed the labeling of your products collected during the inspection, as well as your website at www.sabaforlife.com in March 2014, from which website we have determined that you take orders for several of your products, including your saba ACE, UROPOWER, UROSure, Digest-Eze, Shark Cartilage, Colloidal Silver, and Mobilite. Based on our review, we have determined that your website and other product labeling promote your saba ACE, UROPOWER, UROSure, Digest-Eze, Shark Cartilage, Colloidal Silver, and Mobilite products for conditions that cause the products to be drugs under section 201 (g)(1)(B) of the Act [21 U.S.C. § 321 (g)(1)(B)]. The therapeutic claims on your website and other product labeling establish that the products are drugs 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 claims that provide evidence that your products are intended for use as drugs include:

saba ACE

On the saba ACE product pamphlet titled "ACE Ingredients: The Breakdown":
 

• "Green Tea also helps prevent tooth decay, lowers cholesterol and blood pressure, fights cancer, prevents inflammation and liver disease, fights infection"
 

• "Konjac Root... acts as a blood cholesterol-lowering agent and as a blood sugarlowering supplement for those with diabetes."
 

• "Semonostachya Menglaensis & Lotus Leaf Extract... stop bleeding or to treat blood diseases... can even treat skin disorders."
 

UROPOWER

On the https://www.sabaforlife.com/product/uropower-60-ct webpage titled, "Products saba for you, for life," under the "INFO" tab and on page 4 of your product catalog titled "JOIN The Movement saba for you. for life.":
 

• "UROPOWER® has been proven statistically and clinically beneficial to those who have used it as demonstrated by improving voiding symptoms, PSA, EPS and prostate related ... pain."
 

On the https://www.sabaforlife.com/product/uropower-60-ct webpage titled, "Products - saba for you, for life", under the "USES" tab:
 

• "Decreases discomfort or pain of chronic pelvic pain syndrome"
 

• "Lowers your EPS (white blood cells in the prostate secretion"
 

• "Lowers your voiding symptom score (urinary symptoms)"
 

UROSure

On the https://www.sabaforlife.com/product/urosure-60-ct webpage titled, "Products - saba for you, for life", under the "INFO" tab and on page 4 of your product catalog titled "JOIN The Movement saba for you. for life.":
 

• "UROSure is intended to assist patients with signs and symptoms of chronic bladder Infections ... "
 

On the https://www.sabaforlife.com/product/urosure-60-ct webpage titled, "Products - saba for you, for life", under the "USES" tab:
 

• Helps relieve symptoms of chronic bladder infections"
 

Digest-Eze

On the https://www.sabaforlife.com/product/digest-eze-90-ct webpage titled, "Products saba for you, for life," under the "USES" tab:
 

• "Heartburn"
 

Shark Cartilage

On the https://www.sabaforlife.com/product/digest-eze-90-ct webpage titled, "Products - saba for you, for life," under the "INFO" tab:
 

• "This non-steroidal anti-inflammatory product acts as [a] pain reliever. .. "
 

On the https://www.sabaforlife.com/product/digest-eze-90-ct webpage titled, "Products - saba for you, for life", under the "USES" tab:
 

• "Analgesic"
 

On page 7 of your product catalog titled "JOIN The Movement saba for you. for life.":
 

• "This non-steroidal anti-inflammatory [product] acts as [a] pain reliever ... "
 

Colloidal Silver

On the https://www.sabaforlife.com/product/colloidal-silver webpage titled, "Products saba for you, for life," under the "INFO" tab:
 

• "Colloidal Silver is effective against infections, colds ... Destructive bacteria, virus and fungus organisms are killed within minutes of contact."
 

On the https://www.sabaforlife.com/product/colloidal-silver webpage titled, "Products - saba for you, for life," under the "USES" tab:
 

• "Cataracts"
 

• "Natural Antibiotic"
 

• "Parasites"
 

• "Yeast Infections"
 

On page 8 of your product catalog titled "JOIN The Movement saba for you. for life.":
 

• "Colloidal Silver acts as natural antibiotic. It may be used to kill bacteria, yeast, parasites, and viruses."
 

Mobilite

On the https://www.sabaforlife.com/product/mbilit-20-ct webpage titled, "Products - saba for you, for life," under the "USES" tab:
 

• "Anti-inflammatory"
 

On page 7 of your product catalog titled "JOIN The Movement saba for you. for life.":
 

• "[D]eliver key anti-inflammatory ... benefits."
 

Your saba ACE, UROPOWER, UROSure, Digest-Eze, Shark Cartilage, Colloidal Silver, and Mobilite 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 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.

Furthermore, your saba ACE, UROPOWER, UROSure, and Colloidal Silver products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these products is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their 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)].

Dietary Supplements CGMP Violations

The November 19, 2013, through December 17, 2013, inspection of your facility revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, found in Title 21 of the 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 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. In addition, even if your saba ACE, UROPOWER, UROSure, Digest-Eze, Shark Cartilage, Colloidal Silver, and Mobilite products were not unapproved new drugs, they would be adulterated dietary supplements under section 402(g)(1) of the Act.

As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm's name, your firm has an obligation to know what and how manufacturing 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 [see 72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce in their 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 your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, 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 (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). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery for 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 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.

During the inspection, investigators observed the following significant violations:

1.    Your firm failed to establish specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, your firm has not established finished product specifications for the finished batch of your saba ACE and saba X-treme 5000.

We have reviewed your response letter dated January 2, 2014, and find it inadequate to address the violation. We acknowledge that in your response you stated that you have reviewed and approved the master manufacturing records (MMR) and product specification for each product manufactured for AMS from each contract manufacturer. Your response, however, did not provide information about the specifications you have established.

2. Your firm's 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). Specifically, your firm has neither reviewed nor approved manufacturing processes, MMRs, batch production records, component specifications, finished product specifications, including acceptance criteria, and tests or examinations used by the contract manufacturer of the saba ACE for adequacy, as required in 21 CFR 111.123(a).

We have reviewed your response letter dated January 2, 2014, and find it inadequate to address these violations. We acknowledge that in your response you stated that you have inspected and audited each of your contract manufacturers and that you have requested, reviewed, and approved MMRs and product specifications for all of your products produced by contract manufacturers. The MMRs provided in Exhibit 3 of your response, however, do not include references to any tests or examinations performed. Your firm's inspection/audit checklists (Exhibit 3) of the finished dietary supplements for each contract manufacturer do not indicate what specific procedures, batch sizes, and date of manufacturing were reviewed, nor do they provide their supporting documentation to show the evidence of their review. For example, we note that you submitted a revised MMR for saba X-treme 5000 (b)(4), but the documentation for the revision and approval was not provided. Additionally, your SOP (b)(4) Ensuring Identity, Purity, Strength, and composition of Dietary Supplement, SOP (b)(4) Qualifying Contract Manufacturers, and SOP (b)(4) Receiving Finished Goods Inventory that you provided in your response lack specific instructions for how quality control is supposed to ensure the quality of your products. You must ensure that you have established and followed 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 in 21 CFR 111.103.

3.    Your firm failed to implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65. Specifically, your firm had no procedures for reviewing, verifying, and approving master manufacturing records (MMRs), batch production records, and test results listed in the certificate of analysis for each batch of the dietary supplements and dietary ingredients and non-dietary ingredients provided by your contract manufacturers.

We have reviewed your response letter dated January 2, 2014, and find it inadequate to address the violation. We acknowledge that in your response you stated that you created and implemented a new procedure for receiving finished foods into the warehouse and a procedure for approving and documenting AMS product labeling; your response also stated that you rely on your contract manufacturers to approve the final label. Your firm also submitted with your response SOP (b)(4), titled Receiving Finished Goods Inventory, dated 12/11/13 (attached in Exhibit 2, 6, and 10), which outlines the review and verification process for incoming batches of your dietary supplements. This procedure is deficient as it does not contain specific instructions and acceptance criteria for visual inspection of the product labels and packaging for defects, reviewing batch production records for agreement with master manufacturing records, and supporting test documentation for each batch of dietary supplement. Exhibit 6 includes a certificate of analysis (COA) for lot (b)(4) for the Ace Control Energy capsules (manufacturing dated (b)(4) provided by the contract manufacturer. It lists the analytical test result for each dietary ingredient in the propriety blend as passing, but there is no specification of the individual dietary ingredient listed in the COA or supporting test documentation to show how the propriety blend was tested and accepted for conformance. Additionally, your firm does not provide its review and approval for identity testing of dietary ingredients conducted by the contract manufacturers.

4.    Your firm failed to establish and follow written procedures described in 21 CFR 111.560(b) relating to the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, you do not review or investigate product complaints you receive, and you do not have written procedures for investigating such complaints.

We have reviewed your response letter dated January 2, 2014, and find it inadequate to address this violation. We acknowledge that in your response you stated that you revised your complaint procedures (SOP (b)(4)), effective 12/11/13, attached in Exhibit 2. However, your response does not provide written instructions on how quality control personnel will review and approve decisions to investigate a product complaint, how quality control personnel will review and approve the findings of investigations, and how quality control personnel will follow up on any investigation performed. Your response also does not provide the new Complaint Initiation Form referenced in SOP (b)(4). Although your response explained its investigation results of an adverse event reported in MedWatch Report #160095, your response does not provide documentation of any follow-up with the contract manufacturer and the contract manufacturer's investigation results.

5.    Your firm failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you do not maintain reserve samples of your dietary supplement products. Your firm must hold the reserve samples consistent with the requirements set forth in 21 CFR 111.465.

We have reviewed your response letter dated January 2, 2014, and find it inadequate to address the violation. We acknowledge that in your response you stated that your contract manufacturer will sample and retain each lot of dietary supplements you receive. As a distributor of the products, however, your firm is required to hold reserve samples of packaged and labeled dietary supplements distributed under your firm's name. SOP (b)(4) titled "Collecting Reserve Samples," dated 12/11/13, attached in Exhibits 2 and 13 your response, requires your firm to hold reserve samples at your facility. Your response letter conflicts with SOP (b)(4) in that your response states that your firm's contract manufacturer retains reserve samples at their facility. Additionally, the inspection documented that your firm began contracting with a (b)(4) manufacturer for your saba ACE and saba X-treme 5000 in (b)(4), but your response does not explain the status of the reserve samples held by the previous manufacturer (b)(4).

Misbranded Dietary Supplements

Your saba X-treme 5000 product is misbranded under section 403 of the Act [21 U.S.C. § 343] because it does not comply with FDA's labeling regulations under 21 CFR Part 101. In addition, even if your saba ACE, UROPOWER, and UROSure products were not unapproved new drugs, they would be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343].

1.    Your saba ACE and saba X-treme 5000 products are misbranded under section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] in that the product labels fail to identify the sources for Methyl Synephrine or Synephrine and Phenylethylamine (PEA) in the proprietary blend of dietary ingredients listed in the supplement facts panels, as required by 21 CFR 101.36(d).

2.    Your UROSure product is misbranded under Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it does not declare all ingredients listed on the product label in accordance with 21 CFR 101.4(g). For example, the product is encapsulated but the capsule ingredients are not listed.

3.    Your saba ACE and UROPOWER are misbranded under Section 403(q)(1 )(A) of the Act [21 U.S.C. § 343(q)(1)(A)] in that the serving size listed on the product label is incorrect in accordance with 21 CFR 101.12(b ). For example, the serving size for the saba ACE and UROPOWER is one capsule, but the directions for use indicate to take one or two capsules in the morning or afternoon for the saba ACE product and take 2-3 capsules daily with a meal for the UROPOWER product. 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.

4.    Your saba ACE and UROPOWER are misbranded under Section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] in that the number of servings per container is not listed on the product labels, as required by 21 CFR 101.9(b)(8).

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 and 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.

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.

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)(8)). 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 Thao Ta, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Thao Ta at (214) 253-5217.
 

Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 

cc:
Mr. Gary Hail, President
AMS Health Sciences, LLC
711 NE 39th Street
Oklahoma City, OK 73105-7219

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