Inspections, Compliance, Enforcement, and Criminal Investigations
Algaen Corporation 3/8/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Atlanta District Office|
60 Eighth Street N.E.
Atlanta, GA 30309
March 8, 2013
Fan Lu, President/CEO
925 W. Northwest Blvd.
Winston Salem, NC 27101
Dear Mr. Lu:
On July 31, 2012 - August 1, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 925 W. Northwest Boulevard in Winston Salem, NC. During the inspection, our investigator collected sample labels for your AlgaBerry™ products, which you label as dietary supplements, and evaluated manufacturing operations for these products. In addition, in March 2013, FDA reviewed your website at www.algaen.com, and determined that this website constitutes labeling under section 201(m) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(m)] because the website address appears on the label of your AlgaBerry™ products. Based on the inspection and our review of your product labeling, we have determined that your AlgaBerry™ products are in violation of the Act and applicable regulations. You may find the Act and FDA regulations through links on FDA's website at www.fda.gov.
Unapproved New Drugs
Based on our review of the labeling for your AlgaBerry™ products, including your website, www.algaen.com, we have determined that these products are promoted 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)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. The marketing of these products with such claims violates the Act. Examples of some of the claims observed on your website include, but are not limited to, the following:
• "The nutraceutical and pharmacological effects AlgaBerry™ were historically described as anti-inflammatory ... control of hypertension ... "
• "Modern studies have suggested that AlgaBerry™ may contain a broad range of compounds that have anti-microbial, anti-viral, anti-tumor, or anti-cancer activity."
• "Nostoc was mostly described to treat a variety of medical conditions, including inflammatory, nyctalopia (night blindness) ... chronic fatigue
• " ... Nostoc contain[s] ... active compounds ... that exert nutraceutical and pharmacological effects, which range from anti-microbial, anti-viral to anti-tumor, anti-cancer ... activities."
• "Nostoc also contains a large amount of phycobiliproteins, which have been known to ... have strong ... anti-inflammatory activities."
Your AlgaBerry™ products are not generally recognized as safe and effective for the above referenced uses and therefore, are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. 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.
Furthermore, because your AlgaBerry™ products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Therefore, these products are also misbranded within the meaning of 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. 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
In addition, even if your AlgaBerry™ products were not unapproved new and misbranded drugs, they would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 USC § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet the current good manufacturing practice (CGMP) regulations for dietary supplements in Title 21, Code of Federal Regulations, Part III (21 CFR 111).
During our inspection, our investigators observed the following violations of the CGMP regulations for dietary supplements:
1. You failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient before using the component, as required by 21 CFR 111.75(a)(1)(i).
Specifically, your firm used Spirulina powder (b)(4) as a component in your AlgaBerry™ products. Spirulina generally consists of the dried biomass of the cyanobacterium, Arthrospira platensis. You told to our investigator that you conducted a microscopic examination of the Spirulina powder to verify its identity. However, your microscopic examination of the Spirulina power is not appropriate in that it does not allow for distinction of one of the three Arthrospira cyanobacterium species (A. platensis, A. maxima, or A. fusiformis) or other similar algae that may possess similar morphology with Arthrospira, and therefore, cannot be used to verify the identity of Spirulina powder.
2. You failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement 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.
Specifically, you did not prepare and follow a written master manufacturing record for your AlgaBerry™ products that were manufactured in January 2011.
3. You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255.
Specifically, you manufactured AlgaBerry™ products in January 2011, however, you did not prepare a batch production record for this batch of products.
4. 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 make a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103.
The violations cited in this letter are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products are in compliance with the requirements of the Act and applicable FDA regulations.
You should take prompt action to correct the violations cited in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to promptly correct these violations may result in enforcement action, such as seizure or injunction, without further notice.
In addition, with regards to your dietary supplement manufacturing operations, we note that you have not prepared and kept written procedures for personnel, including written procedures for preventing microbial contamination, hygienic practices, and personnel qualification requirements, as required by with 21 CFR 111.14(b)(1). For example, you did not prepare and keep written procedures for preventing microbial contamination due to an employee's health condition where such contamination may occur (21 CFR 111.10(a)). You also did not prepare and keep written procedures for hygienic practices, including wearing outer garments in a manner that protects against contamination hand washing, removal of unsecured jewelry prior to working with ingredients, maintaining gloves used in handling of components, wearing, where appropriate, hair restraints, not storing clothing or other personal belongings in certain areas, and other steps that would protect against contamination (21 CFR 111.10(b)). Additionally, you did not maintain documentation of personnel training, including the date of the training, the type of training, and the person(s) trained, as required by 21 CFR 111.14(b)(2).
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 determining 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.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above violations cited above. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. Morton at 404-253-1285 or write her at the noted address.
John R. Gridley