Dietary Supplement Safety-Control Compared to FDA-regulated Drug FactoriesSeptember 2013
By Life Extension
Can you imagine having a business where you charge customers
$200 each month for something that cost you only $2.10 !
That’s a markup of about 100 times and it’s not for a patented product.
In 2010, drug companies were charging around $7 for each 500 mg tablet of a generic medicine called valacyclovir. The brand name Valtrex® was priced slightly higher. People with frequent oral or genital herpes outbreaks needed to take one valacyclovir tablet each day to reduce the number of outbreaks they’d suffer.
The annual cost to these consumers was $2,400, yet drug companies paid only $25.20 to produce it. (Valacyclovir is also used in higher doses to treat shingles.)
You would think that with these obscene profits, drug factories would bend over backward to ensure the strictest quality-control standards so as not to jeopardize this lucrative cash cow, much of it guaranteed by your tax dollars.
Instead, with quasi-monopoly status provided by federal regulators who stomp out competition, some pharmaceutical companies ran 24-hour-a-day assembly lines to make as many of these outrageously priced drugs as possible, knowing they had little downside risk by ignoring even rudimentary safety standards.
Over the past 33 years, Life Extension® has inspected hundreds of supplement makers. While some do not meet our exacting standards, we have never seen anything close to the deplorable conditions that have been uncovered inside some of America’s largest drug factories.
One difference between supplement makers and drug factories is that owners of supplement companies often take their own products daily, whereas some pharmaceutical owners apparently live in a state of denial that they will ever need the polluted drugs they sell to others.
The FDA pretends to protect the public against contaminated drugs. The sordid facts reveal an agency incapable of acting in a consistent and logical manner.
Such is the case of a company that made contaminated injectable drugs that have killed and sickened many Americans. The FDA identified problems with this manufacturer as early as 2002, but dropped the ball into a state pharmacy board’s lap that failed to act. The FDA again identified dangerous problems in 2006, but once more failed to take actions other than sending a “warning letter.” The FDA now says it needs more power and money to do its job.
An increasing number of supplement companies are being bought out by pharmaceutical companies. These corporate behemoths have historically shown little regard for their customer’s health and longevity, as demonstrated by the cover-ups of deadly side effects of drugs like Vioxx® that killed tens of thousands of Americans.
This article describes the quality-control mandates for products that carry the Life Extension® brand name.
Since June 2007, there have been strict federal rules in outlining requirements for manufacturing, packaging, labeling and holding dietary supplement products in the United States.
Long before this, however, Life Extension insisted that its manufacturing and packaging partners follow these types of stringent quality control practices to ensure product purity and potency.
Life Extension stays ahead of government mandates by proactively defining and managing quality systems internally with an emphasis on qualification of materials and suppliers, mandating meticulous facility cleanliness, and insisting on rigorous finished goods specification/testing programs.
FDA Inspections of Life Extension
In the year 2000, an FDA inspector showed up at Life Extension and demanded samples of products for the FDA to assay.
The FDA agent was initially belligerent, perhaps expecting a legal challenge to his demand for product samples. Instead, Life Extension’s quality control supervisor provided the FDA with all the requested samples, but let him know that the identical lot numbers would be sent out to two independent assay laboratories to verify any findings the FDA came back with.
During this initial inspection, the FDA agent repeatedly threatened to imprison Life Extension personnel if any problems were found. Life Extension responded that the products had already been assayed and, therefore, we had no concern about what the FDA would find.
Within ten days, the assays from the two independent labs came back on all the products. Upon submitting these assays to the FDA inspector, along with file cabinets full of quantitative analysis results, the FDA agent stated he was calling off the inspection because the quality control procedures employed, as he stated, are “analogous to those of drug companies.” At the time, we took that as a compliment, until recent reports showed how poorly certain drug factories operate.
The FDA inspector indicated that he did not expect that a supplement maker would operate under high quality standards. When the FDA agent was asked if the samples taken ten days earlier met the FDA’s standards, he indicated that they were not yet submitted for assay and would not be because the two independent testing labs had already documented that they met label potency.
The FDA inspected again in 2012. The inspection resulted in zero findings of non-compliance.
NSF® International Registration
Life Extension’s fulfillment facility recently earned cGMP (current Good Manufacturing Practices) registration from NSF International, an organization that provides third party certification programs using state-of-the-art analytical laboratories and a highly skilled staff of chemists and microbiologists.
NSF International registration was based on a demanding two-day audit conducted by NSF International which included an evaluation of Life Extension’s Warehouse & Distribution center, including facility cleanliness and sanitation, as well as various quality systems such as complaint handling/investigations, product returns, training, deviation management and product recall handling. The NSF International registration is widely recognized as an objective “seal of approval” signifying the meeting or exceeding of cGMP requirements and industry standards/best practices for quality.
ConsumerLab and International Fish Oil Standards
Life Extension continues to participate in the voluntary ConsumerLab testing program. The program includes an annual evaluation of various product families for potency and label claim verification. For example, over the past year products were submitted in a variety of categories including Multivitamins, Bone Health, Cancer, B-Vitamins, CoQ10/Ubiquinol and Memory. In 2012, all submitted products met all testing requirements.
ConsumerLab in late 2012 evaluated a wide range of green coffee bean extract supplements and found that 50% failed to meet their label claims. As usual, Life Extension green coffee bean extract, which contains the identical ingredient used in successful clinical studies, came out flawlessly.
Life Extension also continues to participate in the International Fish Oil Standards (IFOS™) testing program for fish oil products. In 2012, over 10 batches were submitted which met or exceeded the industry standards requirements for purity and potency. This is especially important for delicate fish oils that can oxidize and lose their EPA/DHA potency, and/or contain toxic levels of mercury and other heavy metals.
Supplier Management / External Audit Program
Life Extension places high emphasis on the management and evaluation of outside providers … including contract manufacturers and packagers, contract laboratories and raw material suppliers. The evaluation process consists of an assessment of completed regulatory questionnaires as well as an aggressive on-site audit program based on our stringent criteria for manufacturing, packaging, labeling and holding dietary supplement products in the United States. Items of special interest include: cleaning and sanitation procedures, pest control, manufacturing and packaging controls, testing, training and documentation practices.
In 2011, we conducted 13 audits including on-site evaluations of Life Extension’s top contract manufacturers, packagers and laboratories. Audit findings were documented and reported to the suppliers and corrective and preventive actions were requested from each supplier. In several instances, follow-up audits were performed to evaluate the effectiveness of corrective actions. In some cases, suppliers were disqualified for not meeting Life Extension’s exacting quality standards.
In 2012, 26 audits were conducted. These audits include evaluations of new suppliers and/or existing supplier follow-up. This aggressive audit schedule will continue to ensure cGMP compliance and drive continuous improvement initiatives with our manufacturing partners.
Roughly 90% of Life Extension branded products are manufactured in NSF International cGMP registered facilities and the combination of NSF International registration along with Life Extension on-site inspections helps ensure that the products manufactured on our behalf have been produced in accordance with the highest standards.
Internal Audit Program
To ensure compliance with applicable regulations, policies and procedures, the Life Extension Quality Unit maintains a documented system for self-inspections which includes internal audits conducted at the corporate location as well as the distribution center in Coram, NY. Although these internal audits are required annually, they are actually conducted more frequently by choice. Since late 2011, a total of four internal audits have been conducted at corporate and four have been conducted at the distribution center. The findings of these audits are captured under a documented quality-control program which ensures that processes and procedures are constantly being reviewed and evaluated as part of the company’s continuous improvement initiatives.
Raw Material Qualification Program
Before new Life Extension-purchased raw materials can be considered for use in branded products they must undergo an extensive, documented review process to ensure that they meet requirements for identity, potency and purity. These materials are tested at contract analytical laboratories which have been qualified by the Life Extension Quality Unit. Materials are typically assayed for potency via advanced analytical chemistry techniques like high performance liquid chromatography (HPLC) or gas chromatography (GC) and are screened for contaminants such as heavy metals via inductively coupled plasma-mass spectrometry (ICP-MS) and microbes utilizing advanced United States Pharmacopeia (USP) methodology.
Botanical ingredients undergo a higher level of scrutiny, with identity (genus/species) verified through comparison to reference standards utilizing high performance thin layer chromatography (HPTLC) and microscopy methods.
Botanical ingredients are also screened for pesticides as defined in USP <561>, Articles of Botanical Origin. In some cases residual solvents will also be evaluated to ensure that raw materials purchased by Life Extension meet appropriate requirements for safety, purity and efficacy. Based on these qualification activities, raw material specifications are developed for each ingredient which are reviewed and approved by the Quality Unit. Life Extension partners with contract manufacturers to ensure that all incoming test results on these materials meet Life Extension specifications and have been reviewed and approved by the Life Extension Quality Unit before use.