What is all the buzz about?
What's all the buzz about? What’s in those other Supplements??? The New York State attorney general’s office announced on Monday, February 2, 2015 that four national retailers of selling dietary supplements were fraudulent and in many cases contaminated with unlisted ingredients. Walmart, Walgreens, Target and GNC — which showed that roughly four out of five of the products contained none of the herbs listed on their labels. In many cases, the authorities said, the supplements contained little more than cheap fillers like rice and house plants, sand or substances that could be hazardous to people with food allergies.
This why I have chosen Shaklee! You may want to know who is manufacturing your choices before you swallow supplements. Here is a list of Shaklee's Quality Assurance Standards and Shaklee's Good Manufacturing Practices (GMP) Shaklee Difference
Shaklee’s Comprehensive Quality Program
An intensive raw material supplier qualification program:
-A quality audit of the potential supplier’s plant(s).
-Review of any FDA inspection reports of the plant(s) available under the Freedom of Information Act.
-Ingredient pre-screening, which includes tests for pesticides, arsenic, lead and solvent residues.
-Review of supplier test methods.
A detailed product development program which ensures product stability through the specified expiration date or shelf life, including:
-Ingredient potency (100% of label claim)
-Microbiological purity
-Organoleptic properties (color, flavor, taste, texture, etc.)
Formal Shaklee Quality Assurance/Quality Control program:
-Complete QC testing (for identity, purity, potency and integrity) of raw material to validate supplier Certificates of Analysis (COA). Any test failure results in potential rejection of the material and disqualification of the supplier.
-Ongoing QC testing of raw materials from qualified suppliers with validated COA’s and periodic audit testing of all specified parameters.
-Pharmaceutical-style validation of all manufacturing processes.
-Pharmaceutical-style validation of all equipment cleaning processes followed by ongoing monitoring.
-An environmental monitoring program to assure the microbiological integrity of our products.
-A sophisticated preventative maintenance program to ensure that manufacturing equipment is within quality tolerances.
-QC testing of the product for identity, potency, purity (chemical and microbiological) at each stage of the production process.
-Finished product inspection/testing to check samples of contract manufactured products before release.
-A regulatory affairs/ compliance function to assure that our facilities have the necessary licenses and our products are manufactured and labeled according to the appropriate regulations.
FDA GMP’s for the dietary supplement industry
The U.S. Food and Drug Administration (FDA) has published a proposed regulation that would establish “current good manufacturing practices” (cGMPs) for dietary ingredients and dietary supplements.
Similar regulations already exist for foods (food cGMPs) and drugs (pharmaceutical cGMPs). The dietary supplement industry has been required to only meet food cGMPs that address food safety concerns such as equipment cleaning, worker hygiene, and plant sanitation. Pharmaceutical cGMPs incorporate food cGMPs and require proof of product identity, strength, quality, and purity—data achieved through testing, controlled manufacturing, and detailed documentation.
Many consumers of Shaklee dietary supplements and food products are familiar with the more stringent of these regulations, pharmaceutical cGMPs, because many aspects of these manufacturing practices have been part of Shaklee for years. Both raw materials and finished products are tested to ensure their purity, freshness, and safety. Raw materials are assayed for potency and stability to assure that the finished product contains 100% of the bioactive nutrients stated on the label throughout its shelf life. Extensive documentation is maintained to satisfy regulatory requirements, such as in the case that a product has to be recalled. Our documentation meets the highest standards, ensuring that our products contain exactly what the label claims (not misbranded) and do not contain potentially harmful substances (not adulterated).
The manufacturing plants for Shaklee dietary supplements already operate at or above the proposed dietary supplement/ingredient cGMP level. Part of this control is in the form of documented Standard Operating Procedures (SOPs) that address the main components of the proposed cGMPs:
•Personnel
•Physical Plant
•Equipment & Utensils
•Training •Construction •Proper design and selection
•Personal hygiene
•Sanitation & ease of cleaning
•Process controls (temperature, calibration) •Cleanliness of production & storage
•Production & Process Controls
•Holding & Distribution
•QA unit (laboratory assays, inspections, raw materials •Warehousing and finished products Testing •Storage conditions to prevent contamination and ensure product stability
•In-process controls to monitor adherence to specifications and SOP's
•Maintaining production records to ensure batch-to- batch consistency.
•Consumer •Complaints •Records and Record Keeping
•Adverse event monitoring
•Maintenance of records open to FDA Inspection
Consider that the proposed cGMPs do not mandate the use of written SOPs, yet it is doubtful that any company could consistently achieve our high level of product quality without them. Also, Shaklee’s dietary ingredient vendor qualification program far exceeds what is proposed, and only the very best suppliers are able to meet our high standards.
Shaklee Corporation has set the benchmark for many years in compliance with these common-sense requirements—long before the FDA felt it necessary to turn them into law in response to abuses by segments of the dietary supplement industry. Adhering to these requirements takes time, commitment, and money. The new requirements spell out what it takes to make high-quality, high-value dietary supplements. Shaklee not only has a head start on this process, but continues to improve its practices to bring our consumers safe, efficacious dietary supplements that, in our view, are the best of their kind on the market today.
February 2007
