| Public Health Service Food and Drug Administration |
New Orleans District |
Department of Health and Human Services
December 9, 2010
WARNING LETTER NO. 2011-NOL-06
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Bonnie L. Houchin, Owner
New Life Alternatives
262 Lake Chateau Drive
Hermitage, Tennessee 37076-3012
Dear Ms. Houchin:
On July 13 and 19, 2010, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, located at 262 Lake Chateau Drive, Hermitage, Tennessee. Our investigators found you are operating as an own-label distributor, and an initial importer and distributor of “Tongkat Ali” or “Eurycoma Longifolia”. During the inspection, our investigators collected a sample of your “Tongkat Ali”, 400mg/capsule, and labeling. Your product is labeled and promoted as a dietary supplement.
During the inspection, you provided information documenting you receive the imported products via international parcel post and none of your imported shipments were declared, as required by Section 801(a) and (b) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) § 321(a) and (b)]. Per Section 201(ff) of the Act [21 USC § 321(ff)], a dietary supplement shall be deemed to be a food within the meaning of the Act. According to Section 801(m) of the Act [21 U.S.C. § 381(m)], all articles of food being imported or offered for import into the United States require submission of a prior notice; providing the identity of each of the following: the article; the manufacturer and shipper of the article; if known, within the specified period the notice is required to provide, the grower of the article; the country from which the article originates; the country from which the article is shipped; and, the anticipated port of entry for the article. It is a prohibited act under Section 301(ee) [21 USC § 331(ee)] to import or offer for import into the United States an article of food in violation of the requirements under Section 801(m) of the Act [21 USC § 381(m)]. If the requirements of Section 801 of the Act [21 USC § 381] are not met you cannot legally import, market, and distribute your products and the products would be subject to enforcement action under the Act.
In addition, your website at the Internet address http://www.newlifealternatives.com was reviewed on October 20, 2010, and it was determined your “Tongkat Ali” product is promoted for conditions causing the products to be drugs under Section 201(g)(1)(B) of the Act [21 USC § 321(g)(1)(B)].
The therapeutic claims on your website establish this product as a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the product with this claim violates the Act.
The following claim was noted on your website:
• “Tongkat Ali works naturally with your body to increase testosterone levels - which has been found to correct erectile dysfunction & impotence due to lack of desire”
Your product, as noted above is not generally recognized as safe and effective for the above referenced uses; therefore, the product is a “new drug” under Section 201(p) of the Act [21 USC § 321(p)]. Under Section 301(d) and 505(a) of the Act [21 USC §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.
The above is not meant to be a comprehensive list of deficiencies with your firm, your products, or their labeling. It is your responsibility to ensure products marketed and distributed by your firm comply with the Act and all applicable federal regulations.
You should take prompt action to correct these violations and prevent their recurrence. Failure to do so may result in regulatory action, including seizure and/or injunction, without further notice.
We note, during the inspection, the investigator also found a number of deficiencies of Current Good Manufacturing Practice regulations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111).
The inspection revealed the following deficiencies:
• Your firm fails to identify each unique lot within each unique shipment of received product in a manner allowing you to trace the lot to the supplier, the date received, the name of the received product, the status of the received product and to the product which you packaged or labeled and distributed as a dietary supplement; and, use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of the received product [21 CFR 111.165(d)(1) and (2)]. Specifically, your firm fails to maintain the supplier lot numbers for traceability. Additionally, because you do not maintain these lot numbers, you are unable to assign them to outgoing products in case a recall is needed.
• Your firm failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements you distribute [21 CFR 111.83(a)].
• Your firm failed to quarantine product until you were able to ensure the received product meets quality standards [21 CFR 111.165(c)].
• Your firm failed to have adequate written procedures for products you receive for packaging and labeling [21 CFR 111.153].
• Your firm failed to establish specifications to assure product received for labeling and distribution is adequately identified and is consistent with your purchase order and/or contract. Specifically, your firm did not have established specifications to verify the Tongkat Ali product meets the specifications before relabeling them and selling them under your firm’s name [21 CFR 111.70(f)].
• Your firm failed to have representative samples of each unique shipment, and of each unique lot within each unique shipment, of the product you receive and relabel to determine whether the received product meets established specification [21 CFR 111.80(d)].
• Your firm failed to have procedures for products which do not meet the established specifications [21 CFR 111.77(c)].
You should notify this office in writing, within 15 working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include in your response documentation, such as copies of correspondence submitted to FDA, and other useful information to assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Please address your reply to Rebecca A. Asente, Compliance Officer, at the address above. If you have questions regarding the contents of this letter, please contact Ms. Asente at (504) 219-8818, extension 104.
Sincerely,
/s/
H. Tyler Thornburg
District Director
New Orleans District
Enclosure: Form FDA 483, dated July 19, 2010
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