Inspections, Compliance, Enforcement, and Criminal Investigations
DreamLife, LLC 12/1/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
December 1, 2011
WARNING LETTER NO. 2012-NOL-05
UNITED PARCEL SERVICE
Delivery Signature Requested
Brent J. Holland, Owner
Toni S. Holland, Owner
18120 Hosmer Mill Road
Covington, Louisiana 70435-7613
Dear Mr. and Mrs. Holland:
On June 3 and 8, 2011, the U.S. Food and Drug Administration (FDA) inspected your facility, located at 18120 Hosmer Mill Road, Covington, Louisiana. The inspection revealed serious violations of FDA's Current Good Manufacturing Practice (CGMP) in Labeling or Holding Operations for Dietary Supplements (Dietary Supplement Regulations), Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). At the conclusion of the inspection, you were issued a FORM FDA 483, Inspectional Observations, which listed a number of the violations that cause your dietary supplement products to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 United States Code (USC)§ 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet CGMP
requirements for dietary supplements.
In addition, our investigator collected and reviewed samples of the labeling of your dietary supplement products during the inspection of your facility. Based on our review of your product labels, we have determined the products PowerGum and Extreme Colon Cleanser are promoted for conditions which cause them to be drugs within the meaning of Section 201(g)(1)(B) of the Act [21 USC § 321(g)(1)(B)]. The therapeutic claims on your labels establish the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. You may find the Act and the Dietary Supplement Regulations through links on FDA's home page at http://www.fda.gov.
The significant violations documented during the inspection include, but are not limited to, the following:
1. You failed to establish product specifications for limits on those types of contamination which may adulterate, or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). Our investigator noted you had no specifications for any type of contamination for your finished batches of dietary supplements.
In addition, you failed to verify a subset of your furnished batches of dietary supplements identified through a sound statistical sampling plan, or every finished batch, meet product specifications for identity, strength, and composition, and for limits on those types of contamination may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.75(c). Specifically, the inspection disclosed batch records for your PowerGum batches 126314-1 and 126314-2, dated January 4, 2011, which were released as finished products, lacked testing to verify the identity, purity, strength, and composition of the dietary supplements.
In your response, received by our district office on August 2, 2011, you supplied a package containing labeling and an assortment of blank records. We find this response inadequate because you have not addressed the development of finished product specifications regarding contamination, which are required by regulation. Your response also does not address the products you have on the market that have been manufactured without specifications or finished product testing.
2. Your master manufacturing record for your PowerGum product did not establish controls and procedures to ensure each batch met specifications, as required by 21 CFR 111.205(b)(2). The written instructions in the master manufacturing record for your PowerGum do not include specifications for each point, step, or stage in the manufacturing process to ensure the quality of the dietary supplement. Further, your master manufacturing record (MMR) for your PowerGum product did not include the items identified below, as required by 21 CFR 111.210:
• a complete list of components to be used, as required by 21 CFR 111.210(b) (e.g. the active ingredient is identified as Formula 5754DL);
• documentation of individual eight or measure of components, as required by 21 CFR 111.210(c);
• the identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients. list of the dietary supplement, as required by 21 CPR 111.210(d) (e.g. the affidavit signed by Mr. Holland on November 15, 2010, describes the ingredient label to include enzyme blend containing acid protease, amylase, however the MMR lists the ingredients only as digestive enzymes);
• the specifications for each point, step or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement (e.g. times and temperatures), as required by 21 CFR 111.210(h)(1);
• procedures for sampling or a cross-reference to procedures for tests or examinations, as required by 21 CFR 111.210(h)(2);
• instructions for one person to add and another person to verify the addition of the components, as required by 21 CFR 111.210(h)(3)(ii)(A);
• corrective action plans for use when specifications. are not met, as required by 21 CFR 111.210(h)(5); and,
• a description of the packaging and a representative label or a cross-reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g).
In your response, received by our district office on August 2, 2011, you submitted a revised blank "Processing Specification" form (MMR). We find this response to be incomplete, as you have not addressed all of the specifications outlined, as required by 21 CFR 111.210.
3. You did not maintain, clean, and sanitize contact surfaces used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.27(d). Specifically, you last manufactured PowerGum on April 15, 2011, but during our inspection on June 3, 2011, we observed your extruder equipment with leftover remnants from the manufacturing process of April 2011. Equipment and utensils must be taken apart as necessary for thorough maintenance, cleaning, and sanitizing, as required by 21 CFR 111.27(d)(1).
In your response, received by our district office on August 2, 2011, you submitted a blank "Cleaning Procedures & Schedules" form. We will verify compliance during a future inspection.
4. You did not collect representative samples of a subset of finished batches of dietary supplements that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution to verify the finished batch of dietary supplement meets established product specifications, as required by 21 CFR 111.80(c). Specifically, no samples of finished product are maintained at your residence or manufacturing facility. All PowerGum, once manufactured, is released and distributed immediately. You must retain reserve samples of packaged and labeled dietary supplements you distribute for use in appropriate investigations, as required by 21 CFR 111.83(b)(3).
In your response, received by our district office on August 2, 2011, you did not address this violation.
5. You have not identified personnel to be responsible for your quality control operations, as required by 21 CFR 111.12(b). Each person who is identified to perform quality control operations must be qualified to do so and have distinct and separate responsibilities related to performing such operations. This is the second inspection where you have not identified who is part of quality control and instituted the functions of quality control.
In your response, received by our district office on August 2, 2011, you did not specifically address this violation.
6. In your labeling operation for the Extreme Colon Cleanser dietary supplement product, you did not conduct a visual examination of the label and review the supplier's invoice, guarantee, or certification to determine whether label specifications are met, as required by 21 CFR 111.75(f)(2). Specifically, the labeling for your Extreme Colon Cleanser product was not approved by a quality control employee before use in the packaging and labeling of a dietary supplement.
In your response, received by our district office on August 2, 2011, you provided a blank "Label Control" sheet. We will verify compliance during a future inspection.
7. You did not establish and follow written procedures for when a returned dietary supplement is received, as required by 21 CFR 111.503. Specifically, there are no records documenting returned product or procedures regarding what occurs to the returned product after the return. This is the second inspection in which this violation was noted.
In your response, received by our district office on August 2, 2011, you included a "Complaints" form. We find this response to be incomplete, as you did not include written procedures for disposition of returned product that does not involve a complaint.
Unapproved New Drugs
During the inspection at your facility, our investigator collected labels associated with your products, including PowerGum and Extreme Colon Cleanser. Based on our review of your product labeling, we have determined the products PowerGum and Extreme Colon Cleanser are promoted for conditions that cause them to be drugs within the meaning of Section 201(g)(1)(B) of the Act [21 USC § 321(g)(1)(B)]. The therapeutic claims on your labeling establish the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these dietary supplement products with these claims violates the Act.
Examples of some of the claims observed on your product labeling include:
PowerGum (Product brochure reads in part)
• Inositol Hexaniacinate- "Lowers cholesterol"
• Green Tea- "just a few medical conditions reputed to be helped by green tea; cancer, rheumatoid arthritis, high cholesterol levels, cardiovascular disease, infection ... "
• Brown Seaweed Extract (Fucoidan) - "Causes certain rapidly growing cancer cells to self destruct. .. , Fucoidan helps to naturally eliminate harmful cells from organisms."
Extreme Colon Cleanser (Product brochure reads in part)
• Irish Moss ·- "Helps to alleviate peptic and duodental [sic] ulcers."
• Ginger "Lowers both serum and hepatic cholesterol."
• Licorice- "[M]ay inhibit the growth of some cancers .... It also acts as an anti-inflammatory and protects from viral infections.... [E]ases bronchitis and symptoms of colds and influenza and bases [sic] ulcers."
• Cascara Sagrada "[H]elps to prevent calcium based urinary stones."
• MAY HELP "*Prevent Colon Cancer ... *Prevent Common Sickness & Deadly Diseases"
Your products PowerGum and Extreme Colon Cleanser are not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under Section 201(p)(1) of the Act [21 USC § 321(p)(1)]. A new drug may not be legally marketed in the United States without prior approval from FDA as described in Section 505(a) of the Act [21 USC § 355(a)). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
Furthermore, because your 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 a layman can use the products safely for their intended uses. Thus, the labeling of these products fails to bear adequate directions for their intended uses, causing the products to be misbranded under Section 502(f)(I) of the Act [21 USC § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of Section 301(a) of the
Act [21 USC § 331(a)].
Misbranded Dietary Supplements
Your PowerGum product is misbranded within the meaning of Sections 403(i)(1) and 403(s)(2)(B) of the Act because the label fails to identify the product using the term dietary supplement as part of the statement of identity on the principal display panel, as required by 21 CFR 101.3(g).
The violations cited in this letter are not intended to be an all-inclusive list of violations which 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. Furthermore, it is your responsibility to assure your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violation cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including seizure and injunction.
We also note you did not establish written procedures to cover critical steps in the manufacturing process for your PowerGum product, such as procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103, procedures regarding components, packaging and labels, as required by 21 CFR 111.153, and procedures for manufacturing operations, as required by 21 CFR 111.353.
We also note the New Orleans District Office (Compliance Branch) received your undated written correspondence on June 27, 2011. This information will become a part of our official files. The correspondence included a packaging procedure, with no additional data.
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. You should include an explanation of each step being taken to prevent the recurrence of violations, documentation, and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrective actions within 15 working days, state the reason for the delay and the time within which you will complete the correction
Please send your written reply to Kari L. Batey, Compliance Officer, Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. Any questions you may have regarding this process should be directed to Ms. Batey at the above address.
Patricia K. Schafer
New Orleans District Office