| Public Health Service Food and Drug Administration |
Kansas City District |
Department of Health and Human Services
November 8, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref: KAN 2011-02
Craig E. Sallin, Owner
Swedish Bitters Herbs Company
501 Myrtle Street
Syracuse, NY 13204
Dear Mr. Sallin:
On July 6 through July 14, 2010, the U.S. Food and Drug Administration (FDA) inspected your firm located at 110 South Bismark Street, Concordia, Missouri. Your firm manufactures, packages, labels and holds dietary supplements, including "Maria Treben's Authentic Swedish Bitters, (Alcohol 38% by Vol.)" and "Bull Natural Concentrated Pump Tabs". Our investigator and analyst found a number of violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
The inspection revealed the dietary supplement products manufactured in your facility are 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 current good manufacturing practice regulations for dietary supplements. These observations were presented to you in an FDA 483 at the conclusion of our inspection on July 14,2010. We received your July 16,2010 response to the FDA 483 and we have addressed your response below.
The inspection revealed the following violations:
Adulterated Dietary Supplements
1. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use as required by 21 CFR 111.75(a)(1)(i).
Specifically, your firm was unable to provide documentation of the results of tests or examinations to meet this requirement for the dietary ingredients you used to manufacture your dietary supplements.
Your response does not adequately address your failure to meet this requirement. Your letter stated that you think this requirement is unnecessary because your ingredients are considered generally recognized as safe (GRAS) and that your suppliers test them and provide a Certificate of Analysis (CGA) for each ingredient. Under 21 CFR 111.75(a)(1), a manufacturer must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use.
2. Your firm failed to determine whether established product specifications for identity, purity, strength, and composition of the finished batch of the dietary supplement were met to comply with 21 CFR 111.73 and 21 CFR 111.75(c).
Specifically, you did not conduct finished product testing, as required by 21 CFR 111.75(c)(1) and (c)(2), to verify established product specifications for identity, purity, strength, and composition for your finished dietary supplement products. You must conduct appropriate tests or examinations to determine compliance with the specifications that you select that, if tested or examined on finished batches of dietary supplements, would verify that the production and process control system is producing dietary supplements that meet all product specifications (or only those product specifications not otherwise exempt under 21 CFR 111.75(d)).
Your response is inadequate because you state that the cost of ingredient and finished product testing would be prohibitive. As a manufacturer of dietary supplements, you are required to comply with 21 CFR 111.75(c).
3. Your firm 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, your firm was unable to provide written master manufacturing records for any of the dietary supplements manufactured at your facility.
Your response is inadequate, in part, because you did not provide MMRs with your response.
4. Your firm failed to prepare a batch production record every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a).
Specifically, your firm was unable to provide batch records for each batch of dietary supplements manufactured at your facility.
Your response is inadequate because you did not provide any batch records for the dietary supplements your manufacture as evidence that you have implemented this requirement.
5. Your firm failed to establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103.
Specifically, your firm does not have written procedures for quality control operations which include but are not limited to: approving and rejecting 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, and ensuring appropriate analysis is performed
on components and finished products.
Your response is inadequate in that you did not provide any written procedures for your quality control operations to show that you implemented this requirement.
6. Your firm failed to maintain, clean, and sanitize equipment and utensils used to manufacture, package, label, or hold components or dietary supplements as required by 21 CFR 111.27(d).
Specifically, tablet-punch machines used at your facility were observed to have a build up of residual powders from previous manufacturing activities. These machines were used to manufacture Bull Natural Concentrated Pump Tabs. Although there was a log for the equipment to document use, there was no record of maintenance, cleaning, and sanitizing activities taking place as required by 21 CFR 111.35(b)(1)(iii).
Your response did not adequately address this requirement. You did not provide any records to support the maintenance, cleaning, and sanitizing of your equipment and utensils.
Your responses to observations #1 and #8 on the FDA 483 appear to be adequate. You indicated that your exterminator will do a more thorough inspection and that these inspections will occur on a (b)(4) basis. Further, you indicated that you plan to perform a (b)(4) inspection of your facility and will document this on a (b)(4) inspection log. You also indicated that you have appointed an individual to be responsible for Plant sanitation and pest control and that detailed records of these activities will be kept. You also indicated that you appointed one of your employees to be responsible for quality control operations. We will verify the adequacy of these corrections during our next inspection.
Unapproved and Misbranded Drugs
The inspection also revealed that your firm is marketing unapproved new drugs in violation of Section 505(a) of the Act [21 U.S.C. § 355(a)], misbranding drugs in violation of section 502(t)(1) of the Act [21 U.S.C. § 352(t)(1)], and misbranding dietary supplements in violation of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)].
7. Our investigator also collected and reviewed the labeling of your products Swedish Bitters, Heart Food Drops, and Small Flowered Willow Herb, including the product labels for such products and websites at www.swedishbitters.com and www.swedishbittersherbs.com.
Under Section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)(1)(B)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs. FDA reviewed the websites and other labeling cited above and has determined that these products are promoted for conditions that cause the products to be drugs under Section 201(g)(1)(B) of the Act.
Specific examples of claims in the product labeling that promote such products as drugs are as follows:
Small Flowered Willow Herb (website): "Small Flowered Willow- herb-was used for years in Europe for the treatment of Prostate Disease which includes Benign Prostatic Hyperplasia (usually a bacterial infection of the prostate) and Prostate Cancer."
Heart Food Drops (label): "Natural Support for Heart Disease/Stroke Sufferers ... "
Your labeling also contains disease claims in the form of personal testimonials, including:
Swedish Bitters (pamphlet entitled "The Story of Swedish Bitters - the long life elixir"): "As a refugee from the German speaking area of Czechoslovakia, I became ill with typhoid fever. ..jaundice and an obstruction in the intestines ... [a]t night I was hit by terrible pain... [t]hese after pains (sic) of the typhoid fever which sometimes can go on for years. '" One day a woman brought me a small bottle containing a dark brown, strong smelling liquid. She had heard of my illness and wanted to help. The Swedish Bitters had relieved her of a serious complaint."
The marketing of these products with these claims violates the Act.
In addition, these products are not generally recognized as safe and effective for the above referenced conditions for which each is promoted and, therefore, these products are also new drugs under Section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. 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. Moreover, these products are misbranded under Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for these drugs fails to bear adequate directions for use.
Misbranded Dietary Supplements
Even if several of your products did not contain disease claims in their labeling that cause them to be drugs, there are still multiple products that are misbranded dietary supplements.
In your response letter, dated July 16, 2010, you state your products are (conventional) foods not dietary supplements. We disagree with this assertion and, in fact, at least two of your products, Maria Treben's Authentic Swedish Bitters 38% Alcohol and Bull Natural Concentrated Pump Tabs, are specifically labeled as dietary supplements and contain dietary ingredients described under Section 201(f) of the Act [21 U.S.C. § 321(ff)].
8. Your Maria Treben's Authentic Swedish Bitters, Alcohol (38% by Vol.) is misbranded under Section 403(q)(5)(F) of the Act (21 U.S.C. § 343(q)(5)(F)] in that the nutrition information in the labeling rai Is to meet the requirements of 21 CFR 101.36. For example:
• The product label does not specify the total quantitative amount by weight of the proprietary blend as required by 21 CFR 101.36(c)(3). Individual amounts of the ingredients in the blend are not required to be declared.
• Calories and Total Carbohydrates are declared on your product label as zero, but when such ingredients are present in amounts that can be declared as zero they must not be listed on the "Supplement Facts" panel at all, as required by 21 CFR 101.36(b)(2)(i).
9. Your Bull Natural Concentrated Pump product is labeled as a dietary supplement. However, the product is misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the label fails to bear nutrition labeling ("Supplement Facts" panel), which is required under 21 CFR 101.36, and is not exempt from this requirement.
This letter is not intended to be an all-inclusive review of your products and their labeling or your CGMP violations. You should take prompt action to correct these violations. You also should review the labeling for all of your products and your manufacturing practices to ensure that they comply with the applicable requirements of the Act and all implementing regulations. Failure to do so may result in enforcement action without further notice, such as seizure and/or injunction.
Please respond in writing within 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. You should include in your response documentation such as revised labels, logs and written procedures as specified above, or any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, explain the reason for the delay and state when you will correct any remaining violations.
Your response should be sent to Patrick L. Wisor, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 11630 West 80th Street, Lenexa, Kansas 66214-3340. If you have any questions about this letter, please contact Compliance Officer Patrick L. Wisor at 913-752-2730.
Sincerely,
/S/
for/ John W. Thorsky
District Director
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