Inspections, Compliance, Enforcement, and Criminal Investigations

VitaSea Products Int'l, dba Wachters Organic Sea Products 2/25/16

  

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

Public Health Service
Food and Drug Administration
 
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Telephone: 510/337-6700 

 

WARNING LETTER
  
 
February 25, 2016      
                                   
Via UPS Overnight Delivery
Return Receipt Requested
 
Carrie J. Minucciani, President
VitaSea Products Int’l, Inc. dba Wachters Organic Sea Products
550 Sylvan St
Daly City, CA 94014
                                                                                               
Dear Ms. Minucciani:
 
The U.S. Food and Drug Administration (FDA or we) evaluated your website at Internet address www.wachters.com in July and December 2015 and determined that certain claims on your website establish that several of your products are unapproved new drugs and/or misbranded drugs under the Federal Food, Drug, and Cosmetic Act (the Act). Further, we inspected your facility located at 550 Sylvan St., Daly City, California, from April 2, 2015, through April 17, 2015.  Based on our inspection and subsequent review of your product labeling collected during the inspection, we found additional serious violations of the Act and applicable regulations.  You may find the Act and FDA’s implementing regulations through links on FDA’s home page at www.fda.gov.
 
Unapproved New Drugs and Misbranded Drugs
 
FDA reviewed your website at the Internet address www.wachters.com in July and December 2015 and has determined that you take orders there for the products No. 54 Vitamin C and Quercetin, No. 2 Aqua Terra, No. 3 Sea Green Drink, No. 11 Sea Klenz with Phytoenzymes, WMH Migraine-B-Gone, WTCB T Cell Balancer, and No. 19 N-er-G. 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.[1] 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 NEWS FLASH section of your website’s main page:
  • “Seaweed Kills cancer cells and HIV virus” (seaweed is an ingredient in some of your products, including No. 19 N-er-G)
On your various product information pages:
 
No. 54 – Vitamin C and Quercetin:
  • “Quercetin helps the body fight off allergic reactions” 
No. 2 – Aqua Terra (listed under the Product Spec Sheet):
  • “Assists the body to fight colds, flu and other types of infection”
  • “May heal wounds, burns and ulcers”
  • “May ease inflammatory bowel disease”
  • “May have significant effect upon the healing of intestinal ulcerations in Crohn’s disease”
  • “May be beneficial in . . . epilepsy . . .”
  • “May reduce the number of perioperative infections, improve *wound healing and shorten recovery time”
  • “Used by Native Indians for healing a variety of skin eruptions, wounds, sprains, painful joints and broken limbs”
  • “[H]elps with inflammation, healing and pain”
  • “Has been shown to reduce swelling, pain and stiffness in patients suffering from acute bone and joint pain”
No. 3 – Sea Green Drink (listed under the Product Spec Sheet):
  • “[A]nti-inflammatory, anticarcinogenic and cholesterol lowering actions”
  • “Used to reduce hay fever and other allergic conditions”
  • “Minimizes symptoms of hay fever and asthma”
  • “Helps reduce inflammation”
  • “Helps reduce the release of histamine (which causes allergy symptoms such as congestion)”
  • “May help with hay fever, sinusitis and asthma”  
No. 11 – Sea Klenz with Phytoenzymes (listed under the Product Spec Sheet):
  • “[M]ay eliminate parasitic organism such as intestinal worms”
  • “[U]sed to treat less serious digestive disorders”
  • “[L]essen inflammation associated with rheumatoid arthritis, improve healing of  injuries”
  • “[U]sed to . . . lower cholesterol”
  • “Helps reduce side effects of radiation therapy”
  • “[U]sed to treat diabetic patients”
  • “Contains beta-glucan . . . shown to lower cholesterol risk”
  • “Beta-glucan can also stabilize blood sugar levels”
  • “Contains . . . avenanthramides, known to help prevent free radicals from damaging LDL cholesterol”
  • “Helps protect against osteoarthritis” 
WMH – Migraine-B-Gone (listed under the Product Spec Sheet):
  • “[U]sed to ease pain and reduce inflammation”
  • “[H]as . . . fever-reducing, antiseptic . . . properties”
  • “Aids in fighting depression”
  • “Used for many conditions including . . . insomnia and inflammations”
WTCB – T Cell Balancer (listed under the Product Spec Sheet):
  • “[U]sed as a diuretic, hypotensive, vasodilator . . .”
  • “[L]ower blood pressure . . . fighting, colds and lung problems”
  • “May help speed recovery for patients whose immune system has been compromised by chemotherapy or radiation”
  • “Helps . . . lowering cholesterol, acting as an anticoagulant”
  • “Helps . . . lowering cholesterol, acting as an anticoagulant”
  • “Research has shown to improve hypertension, bronchitis and hepatitis”
  • “Studies have shown a faster recovery from flu and colds”
  • “[A]pproved for colds”
  • “Has demonstrated anti-inflammatory, anti-viral and diuretic actions”
  • “Known to slowly eat away cholesterol deposits; may provide relief from concurrent hypertension”
  • “Helps regulate cholesterol and lipid levels” 
No. 19 – N-er-G (listed under the Product Spec Sheet):
  • “May have antimutagenic and anticarcinogenic activities”
  • “Eases pain and reduces inflammation”
  • “Treats asthma”
  • “Helps prevent cataracts”  
Your products are not generally recognized as safe and effective for the above referenced uses; 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 submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your No. 2 – Aqua Terra, No. 3 Sea Green Drink, No. 11 Sea Klenz with Phytoenzymes, No. 19. N-er-G, WTCB T Cell Balancer, and WMH Migraine-B-Gone products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for the layperson to use your products safely for their intended purposes. Accordingly, No. 3 Sea Green Drink, No. 11 Sea Klenz with Phytoenzymes, No. 19. N-er-G, WTCB T Cell Balancer, and WMH Migraine-B-Gone are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Dietary Supplements 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)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements.   
 
1.    You failed to establish required specifications for points, steps, or stages 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 master manufacturing record, as required by 21 CFR 111.70(a). You failed to:
  • Establish specifications for each component that you use in the manufacture of a dietary supplement, including identity specifications; specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met; and the limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b).
  • Establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(c)(1).
  • Establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement you manufacture, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
  • Establish specifications for the packaging and labeling of the finished packaged and labeled proprietary dietary supplement products, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g).
Specifically, you have established no written specifications for your production and process control system. Once you have established the above specifications, you must verify that the established specifications are met in accordance with 21 CFR 111.73 and 21 CFR 111.75, and you must make and keep records of your production and process control system in accordance with 21 CFR 111.95(b).
 
2.    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, as required by 21 CFR 111.103. Specifically, you have no written procedures established or documented for quality control operations.
 
Once you have established the responsibilities of quality control operations, your firm’s quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of your dietary supplements and that your dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105.
 
3.    You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, the limited documentation you provided during the inspection that you purport of use as an MMR for your WDCR Sinus-B-Gone:
 
o    Failed to establish controls and procedures to ensure that each batch of dietary supplement that you manufacture meets the specifications for the points, steps, or stages 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 master manufacturing record (21 CFR 111.205(b)).
 
o    Failed to establish written instructions for verifying the weight or measure of any component and verifying the addition of any component (21 CFR 111.210(h)(3)(i).
 
o    Failed to include a description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label (21 CFR 111.210(g)).
 
4.    Your batch production record (BPR) failed to accurately follow the appropriate MMR, as required by 21 CFR 111.255(c). Specifically, our review of your production records shows that the following BPRs list ingredients that are used in a quantity different than the value listed on your “formula batch records”:
  • Wachter’s brand Children’s Chewys, control # 29641
o   The weight quantities for two ingredients listed on your BPR were altered and replaced with different quantities than what are listed in your MMR. Specifically, your MMR calls for (b)(4) g red beet powder and (b)(4) g xylitol to be added to the product; however, your BPR shows that for red beet powder, “(b)(4)” was crossed out and “(b)(4)” was written in on the BPR, and that for xylitol, you used (b)(4) g instead of the (b)(4) g listed in your MMR.
  • Wachter’s brand WDCR Sinus-B-Gone control # 35331
o   The weight quantities for two ingredients listed on your BPR were altered and replaced with different quantities than what are listed in your MMR. Specifically, your MMR calls for (b)(4) g ginger root and (b)(4) g coltsfoot to be added to the product, however, your BPR shows that for ginger root, “(b)(4)” was crossed out and “(b)(4)” was written in on the BPR, and that for coltsfoot, you used (b)(4) g instead of the (b)(4) g listed in your MMR.
 
5.    Your BPR failed to provide documentation in accordance with the requirements for 21 CFR 111.260(j) and (l). Specifically, your “(b)(4)” form for WDCR Sinus-B-Gone failed to have a place for the initials of the person responsible for verifying the weight or measure of each component used in the batch, as required by 21 CFR 111.260(j)(2)(ii) and documentation at the time of performance that the quality control personnel reviewed the batch production record as required by 11.260(l)(1).
 
6.    You did not take all necessary precautions during the manufacture of a dietary supplement to prevent contamination of components and dietary supplements, as required by 21 CFR 111.365. Specifically, during the inspection, while observing manufacturing operations, our investigator noted the following conditions:
  • During the preparation of the components for your Wachter’s brand Aqua Pro Protein Supplement Drink, your production personnel wiped off food contact surfaces with rags that had touched the rungs of the ladder that was being used.
  • Your hair blower used to (b)(4) pills was encrusted with dust.
  • Your (b)(4) dust collector, which you use to pull air out of the manufacturing area and up to the top floor when the (b)(4) and (b)(4) are in use, had a thick accumulation of dust particles caked on the bottom of the equipment and filter bags.
7.    You failed to establish and follow written procedures for fulfilling the requirements for returned dietary supplement, as required by 21 CFR 111.503. Specifically, you have no established written procedures for the disposition of returned dietary supplements.
 
Misbranded Dietary Supplements
 
Further, during the inspection of your facility, our investigators collected labels associated with your Wachters’® Children’s Chewys, Wachters’® Aqua-Pro, and Wachters’® WDCR Sinus-B-Gone. Our review of your product label revealed that these products are misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101, as discussed further below. 
 
1.    Your “Wachters’® Children’s Chewys,” “Wachters’® Aqua-Pro,” and “Wachters’® WDCR Sinus-B-Gone” products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that they are fabricated from two or more ingredients, and each ingredient is not declared on the labels by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. For example,
  • Your “Wachters’® Children’s Chewys” and “Wachters’® WDCR Sinus-B-Gone” products are manufactured into tablets, but the labels fail to declare tablet ingredients (e.g., excipients, fillers, binders).
  • Your “Wachters’® WDCR Sinus-B-Gone”, “Wachters’® Children’s Chewys” and “Wachters’® Aqua-Pro” product labels fail to declare the common or usual name for the ingredient “multi-marine plant sources”, that being the term that further defines “Sea Vegetation.”
2.    Your “Wachters’® Children’s Chewys” and “Wachters’® WDCR Sinus-B-Gone” products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C.  § 343(s)(2)(C)] because 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 “Wachters’® Children’s Chewys” product label fails to include the part of the plant from which “stevia extract” and “red beet” are derived.
  • Your “Wachters’® WDCR Sinus-B-Gone” product label fails to include the part of the plant from which “horehound” is derived.
3.    Your “Wachters’® WDCR Sinus-B-Gone” product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2 is the maximum amount consumed per eating occasion as recommended on the product label. The directions of use on the product label suggest the consumer take two tablets twice a day, but the serving size lists 4 tablets. The serving size listed should be two tablets.
 
4.    Your “Wachters’® Aqua-Pro” product label indicates that the product “provides all the B vitamins, Vitamins C & E.” However, the Supplement Facts panel only provides nutrition information for vitamin B12. Under 21 CFR 101.54(c), the nutrient content claim “provides” may be used on the label, provided that the food contains 10 to 19 percent of the RDI or the DRV per reference amount customarily consumed. Under 21 CFR 101.36(b)(2)(i), the nutrition labeling for dietary supplements shall declare the content of vitamin C when vitamin C is present in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling. As you have included a nutrient content claim on your label that asserts that your product contains at least 10 percent of the RDI for vitamin C, we assume that your product contains an amount of vitamin C by weight that exceeds the amount that can be declared as zero in nutrition labeling; therefore, your nutrition labeling must declare the amount of vitamin C in a serving of your product. Additionally, under 21 CFR 101.36(b)(2), any other vitamins listed in § 101.9(c)(8)(iv), which include vitamin E and the many of the B vitamins (i.e., thiamine, riboflavin, niacin, pantothenic acid, biotin, folic acid), shall be declared when a claim is made about them. As you have made a claim about vitamin E and all the B vitamins, your product fails to satisfy the requirements of 21 CFR 101.36(b)(2). This product is misbranded within the meaning of section 403(q)(5)(F) of the FD&C Act because the label does not list those dietary ingredients that are present in the product in a significant amount and for which a recommendation for daily consumption has been established. 
 
We also have the following comments: 
  • Your “Wachters’® Children’s Chewys” indicates the source of the Vitamin C and iron as Ester C® and Ferronyl®, respectively. Trademark names are not the common or usual name of the source of the dietary ingredient.
  • Your “Wachters’® Aqua-Pro” product does not indicate the unit of measure with respect to the number 34. We believe the unit of measure should be grams. In addition, we note that the approximate number of servings per container is incorrect if the serving size is 34 grams and the container net contents is 454 grams.
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. 
 
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 Lawton W. Lum, Director of Compliance, at the address noted above and should reference unique identifier 471812.  If you have any questions concerning this letter, please contact Compliance Officer Sergio Chavez at (510) 337-6886.
 
Sincerely,
/S/
Kathleen M. Lewis, J.D.
District Director
San Francisco District


______________________________ 

[1] As defined in 21 CFR 101.93(g)(1), a “disease” is “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.” 

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