Ms. Deborah Soule
- Avena Botanicals, Inc.
219 Mill Street
Rockport, ME 04865
- Issuing Office:
- New England District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
CMS # 435131
VIA UNITED PARCEL SERVICE
November 3, 2014
Avena Botanicals, Inc.
219 Mill Street
West Rockport, ME 04865
Dear Ms. Soule:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 219 Mill Street, West Rockport, Maine from May 22, 2014 through May 30, 2014. 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 its implementing regulations.
You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov
Unapproved New Drug
The FDA reviewed your website at http://www.avenabotanicals.com in July of 2014, and has determined that you take orders there for the products “Astragalus Liquid Extract,” “Black Cohosh Root Liquid Extract,” “Calendula Liquid Extract,” “Echinacea Root Liquid Extract,” “Gotu Kola Liquid Extract,” “Milk Thistle Seed Liquid Extract,” “Red Clover Liquid Extract,” “St. John’s Wort Liquid Extract,” “Turmeric Root Liquid Extract,” “Willow Bark Liquid Extract,” “Heal-All Salve,” “Urinary Tract Tonic,” “U.T.I. Relief,” and “Lung Tonic,” which the website promotes 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 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 of the website claims that provide evidence that your products are intended for use as drugs include:
“Astragalus Liquid Extract”
- “It is indicated for people experiencing…shortness of breath…to treat recurrent colds and upper respiratory tract infections.”
“Black Cohosh Root Liquid Extract”
- “[R]educing post-partum pain. It is also traditionally used for easing muscular pain associated with rheumatoid and osteoarthritis, and for relieving asthma.”
“Calendula Liquid Extract”
- “[A]bility to heal cuts, wounds, diaper rash and athletes foot …Calendula is known to help heal vaginal infections and prevent and resolve herpes.”
“Echinacea Root Liquid Extract”
- “Echinacea is indicated for acute viral and bacterial infections such as colds, flus, bronchitis, sinusitis, tonsillitis, and ear infections.* Use every few hours during the acute stage.”
“Gotu Kola Liquid Extract”
- “[H]elps heal red, hot and inflamed skin afflictions such as Eczema and Psoriasis. Inhibits scar tissue formation and promotes healing after surgery or radiation.”
“Milk Thistle Seed Liquid Extract”
- “[U]sed for preventing and treating liver damage, especially when caused by exposure to toxic chemicals and poisons, including mushrooms, alcohol and recreational drugs. Traditionally indicated for conditions such as Cirrhosis of the Liver, Hepatitis A, B and C, and Psoriasis.”
“Red Clover Liquid Extract”
- “[I]t has a long history of use for easing spasmodic coughs, bronchitis, pertussis, tonsillitis and lymphatic congestion. This herb is safe and effective for children with eczema…”
“St. John’s Wort Liquid Extract”
- “St. John's Wort is traditionally used to…nerve pain…and to reduce painful symptoms of arthritis, gout and injury to nerve endings.* Traditionally, St. John's Wort is combined with Calendula, Lemon Balm and Licorice for preventing and resolving Herpes outbreaks.”
“Turmeric Root Liquid Extract”
- “Turmeric has been used to reduce inflammation…”
“Willow Bark Liquid Extract”
- “Willow Bark has a long history of use for easing pain and inflammation and reducing fever and headache.”
- “…[U]sed to heal cuts, abrasions… radiation burns…”
“Urinary Tract Tonic”
- “[U]sed to prevent reoccurring urinary tract infections by healing endothelial tissue.”
- “[U]sed in the treatment of an acute urinary tract infection such as cystitis and urethritis. These herbs are known for their antibacterial and anti-inflammatory properties specific for disinfecting and soothing the mucus membranes of the urinary tract, decreasing inflammation …This formula can be combined with Marshmallow Root Elixer as part of a healing protocol for interstitial cystitis.”
- “The herbs in this formula are traditionally used for…preventing recurrent respiratory infections. For people who are prone to respiratory infections during a certain time of the year, this tonic can be helpful if started a few months before the usual onset.”
Your 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 “Astragalus Liquid Extract,” “Black Cohosh Root Liquid Extract,” “Calendula Liquid Extract,” “Echinacea Root Liquid Extract,” “Gotu Kola Liquid Extract,” “Milk Thistle Seed Liquid Extract,” “Red Clover Liquid Extract,” “St. John’s Wort Liquid Extract,” “Urinary Tract Tonic,” “U.T.I. Relief,” and “Lung Tonic” 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 drugs are 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)].
Adulterated Dietary Supplements
Even if your “Black Cohosh Root Liquid Extract,” “Gotu Kola Liquid Extract,” and “Echinacea Root Liquid Extract” products did not have therapeutic claims which make them unapproved drugs, these dietary supplement products are 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 that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
Specifically, during our inspection, our investigators observed the following significant violations, which were noted on form FDA 483, Inspectional Observations, issued to you on May 30, 2014. We received your written response dated June 19, 2014 to the Form FDA 483. As discussed in more detail below, review of your response and related documentation revealed that your firm has not made adequate corrections.
1. You failed to establish the 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). Specifically,
- You failed to establish the following component specifications for each component that you use in the manufacture of a dietary supplement:
- Identity specifications for your powdered dietary ingredients, as required by 21 CFR 111.70(b)(1). Specifically, your “(b)(4)” include specifications for fresh or dry ingredients only and not powders.
- Component specifications that are necessary to ensure that specifications for the purity and strength of dietary supplements manufactured using the components are met as required by 21 CFR 111.70(b)(2). For example, you do not have specifications for the purity of the following components: black cohosh root and echinancea.
- Limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement as required by 21 CFR 111.70(b)(3). For example, you do not have contamination limit specifications for the following components: black cohosh root and echinancea.
We acknowledge that you address this violation in your response,dated June 19, 2014. We find your response to be inadequate in that your specifications document failed to include specifications for identity, purity, strength, and limits on contaminants for dietary ingredients used in the manufacture of dietary supplements. The specification document you included with your response only provided general contamination specifications for components received from identified geographic locations.
2. You have not prepared or followed 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). For example, on May 27, 2014, our investigator observed your firm prepare a batch of “(b)(4)” which deviated from the master manufacturing record. “(b)(4),” batch number (b)(4), was manufactured using (b)(4) of dried black cohosh root, (b)(4) of ethanol and (b)(4) of spring water. The master manufacturing record with the Ratio (b)(4) for this product states that (b)(4) of dried black cohosh root, (b)(4) of ethanol and (b)(4) of spring water are to be used to manufacture “(b)(4).” In addition, the batch record, dated (b)(4), for “(b)(4),” batch number (b)(4), was also observed to deviate from the master manufacturing record. Your firm was observed adjusting the batch size depending on actual botanical weight without preparing a MMR for each batch size.
We acknowledge that you address this violation in your response dated June 19, 2014. The adequacy of your response cannot be evaluated because you only provided master manufacturing records for multiple recipes of “(b)(4).”
3. Your batch production records (BPR) failed to include complete information related to the production and control of each batch, as required by 21 CFR 111.255(b). Specifically, your BPRs for (b)(4) did not include the following information:
- The identity of the equipment used in producing the batch [21 CFR 111.260(b)]. For example, the identity of the pressing machine and/or filer cloth used for pressing batches was not listed on the BPR for “(b)(4)” batch numbers (b)(4) (pressed on (b)(4)).
- Documentation, at the time of performance, of the manufacture of the batch [21 CFR 111.260(j)]. Specifically, the following information was not documented in your BPRs at the time of performance:
- The initials of the person responsible for weighing or measuring each component used in the batch [21 CFR 111.260(j)(2)(i)];
- The initials of the person responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)];
- The initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)(iv)].
- The results of any testing or examination performed during the batch production, or cross-reference to such results [21 CFR 111.260(h)].
- Documentation that the finished dietary supplement meets specifications in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)].
- Documentation, at the time of performance, of packaging and labeling operations including: the unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels; an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR; and the results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)].
- Documentation at the time of performance, that quality control personnel performed required actions [21 CFR 111.260(l)].
- Documentation at the time of performance of any reprocessing [21 CFR 111.260(n)].
We acknowledge that you address this violation in your response dated June 19, 2014. We cannot evaluate the adequacy of your response because it is missing the required elements and the example you provided of the revised “(b)(4)” record refers to a Recipe Size with a notation of “(b)(4)” as well as noting recipe sizes of (b)(4) and (b)(4). Each formulation and batch size should have its own master manufacturing record and corresponding batch records as opposed to scaling batches per one master manufacturing record.
4. You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i). Specifically, you conduct organoleptic examinations to determine the identity of powdered dietary ingredients. This type of testing is inadequate for powdered dietary ingredient components in that it is not possible to verify the identity of powdered components via organoleptic means.
We acknowledge that you address this violation in your response dated June 19, 2014. You stated that you intend to perform microscopic examinations as well as organoleptic examinations to identify the dietary ingredients. We cannot evaluate the adequacy of this response because you failed to provide any documentation that would allow us to determine whether you are now performing the testing or examination that is required to verify the identity of components that are dietary ingredients under 21 CFR 111.75(a)(1)(i).
Misbranded Dietary Supplements
Further, even if your “Black Cohosh Root Liquid Extract,” “Gotu Kola Liquid Extract,” and “Echinacea Root Liquid Extract” products were not unapproved new drugs , they would still be misbranded dietary supplements within the meaning of section 403 of the Act [21 U.S.C. § 343]. The inspection revealed the following violations of labeling requirements for dietary supplements,
1. Your “Black Cohosh Root Liquid Extract,” “Gotu Kola Liquid Extract,” and “Echinacea Root Liquid Extract” products are misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)] because they fail to bear nutrition information (“Supplements Facts” panel) as required by 21 CFR 101.36.
This letter is not intended to be an all-inclusive list of violations which exist in connection with your products. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in enforcement action, without further notice, including, without limitation, seizure and/or injunction.
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 re-inspection-related costs. A re-inspection 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 determining 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations noted above and prevent their future recurrence. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete the corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
Please send your written reply to the Food and Drug Administration, Attention: Mr. Todd Maushart, Compliance Officer, One Montvale Ave, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Maushart at 781-587-7578
New England District Office
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