Good Manufacturing Practices – What is the Law?
It is my understanding, after reviewing the documents listed as resource at the bottom of this post that as of June 2009 all companies in the United States are required to comply with the laws of GMP. Exactly what is the law on Good Manufacturing Practices meant to cover? Even IF it were not the law, Waiora has emphatically stated that they comply strictly with all GMP requirements.
CGMP Final Rule:
- The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements.
- The current good manufacturing practices (CGMPs) final rule will require that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.
- The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S.
- The rule establishes CGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition.
- The requirements include provisions related to:
- the design and construction of physical plants that facilitate maintenance,
- proper manufacturing operations,
- quality control procedures,
- testing final product or incoming and inprocess materials,
- handling consumer complaints, and
- maintaining records.
Remember, this law is meant to protect consumers who purchase dietary supplements. While I am not in favor of MORE FDA interference in the dietary supplement industry, I am absolutely in favor of Good Manufacturing Practices that protect us from such things as label and ingredient compliance!
- Under the Dietary Supplement Health and Education Act (DSHEA), manufacturers have an essential responsibility to substantiate the safety of their products and for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading.
- The CGMPs will help to ensure manufacturers produce unadulterated and properly labeled dietary supplements.
- Under the CGMP rule, manufacturers are required to:
- Employ qualified employees and supervisors;
- Design and construct their physical plant in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, labeling and holding;
- Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use;
- Establish and use master manufacturing and batch production records;
- Establish procedures for quality control operations;
- Hold and distribute dietary supplements and materials used to manufacture dietary supplements under appropriate conditions of temperature, humidity, light, and sanitation so that the quality of the dietary supplement is not affected;
- Keep a written record of each product complaint related to CGMPs; and
- Retain records for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.
Examples of product quality problems that the rule will help prevent are:
- dietary supplements that contain ingredients in amounts that are greater than those listed on the label dietary or supplements that contain ingredients in amounts that are less than those listed on the label
- wrong ingredient,
- other contaminant (e.g., bacteria, pesticide, glass, lead),
- foreign material in a dietary supplement container,
- improper packaging, and
OK that seems pretty clear to me. The FDA Good Manufacturing Practices LAW is supposed to protect consumers from the above, including supplements that contain ingredients in the amounts that are more or less than those listed on the label, and products that are mislabeled.
November 6th officially marked 7 MONTHS since I sent a simple email to "General Manager, North America" at Waiora.That email was very simple..
From: Shelley Penney
To: General Manager North America
Sent: Wednesday, April 6, 2011 6:12:20 PM
Subject: Have you seen this? NCD analyzed by independent lab
An independent lab tested our NCD and found 2300mg in 10 Bottles (an average of 230 mg per bottle)! But we say 24mg per dose which means there should be 2400 mg in EACH bottle.
Can we get an answer on this?
Since that time, because I didn't get an answer that made any sense, I had someone take bottle of NCD to an independent lab … a DIFFERENT lab in a DIFFERENT state. The owner of the lab (Someone who had NEVER heard of Waiora), performed a test. He was asked to answer the question "How much dissolved solids are in this bottle after you let the water evaporate?" (paraphrased) Here is the resulting test (full story here) . THAT test showed 27mg of solids in a bottle that claimed 2400! As a consumer, and a distributor TO consumers, of this product I am within my legal rights to ask that Waiora explain these test results.
- Why do these tests show an ingredient in a SIGNIFICANTLY lower amount than the label says?
- On MAY 31st, 2011 The Vice President of New Business Development at Waiora sent the following email.
- 5/31/11…during the MLC meeting, John shared you’d recently done some testing of NCD, and the results you’d received were not consistent with the labeling of the product. Can you please provide a copy of the results to us? You can email to me, or fax. (Company Owner) would like to review the results (in addition to sending product to a third-party lab familiar with zeolite testing). Thanks, (title)
Was that test done as was mentioned in that email? If it was, why hasn't anyone shown the results, even after being asked by different people on several occassions? The company claims that the label has ALWAYS been correct, and they follow strict GMP. It would be (would have been) so easy to just show the test at ANY time between now and then, along with the name of the independent lab that did the testing so the results could be verified.
- Allow me to quote from the GMP FDA document
Requires a qualified person to investigate any "product complaint" that involves a possible failure of a dietary supplement to meet any CGMP requirement, with oversight by quality control personnel; and Requires records associated with the manufacture, packaging, labeling, or holding of a dietary supplement to be kept for 1 year beyond the shelf life dating (when such dating is used, such as expiration dating, shelf life dating, or “best if used by'' dating), or if shelf life dating is not used, for 2 years beyond the date of distribution of the last batch
Which qualified person investigated my original query regarding the test that was brought to my attention and what were the results of said investigation? Which qualified person investigated the second test result, which I had commissioned and paid for myself with an independent lab, and what were the results of said investigation. I have had these questions (as yet) unanswered.
Further to handling of complaints the GMP document states:
- l. Written procedures for product complaints (final subpart O). We agree with the comments that written procedures for handling consumer complaints (now called product complaints) will encourage companies to handle product complaints in a consistent manner and help ensure the essential information is captured during investigation of a product complaint. The final rule requires you, among other things, to review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications; investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications; and extend the review and investigation of the product complaint to all relevant batches and records. These operations must be conducted in a consistent manner, regardless of who conducts the operation or when it is conducted. Failure to comply with these requirements for review and investigation of a product complaint in a consistent way could lead to a failure to ensure the quality of the dietary supplement. For example, if you do not have a procedure in place to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, you may not recognize that a particular product complaint is indicative that a problem has occurred with one of your manufacturing processes. That undiscovered problem may lead to continued distribution of product that is contaminated or otherwise not consistent with your specifications in the master manufacturing record. Therefore, we include in final subpart O a requirement that you establish and follow written procedures to fulfill the requirements of subpart O (final Sec. 111.553).
The Waiora company owner, has copies of the same tests that I have, and the management team has been aware of the first test in question AT LEAST since the April 6th, 2011 when I sent the initial email. The company owner can confirm that he has several emails from me that show that I sincerely wanted an answer that made sense so that I could continue to stand behind, consume and sell the Natural Cellular Defense product. I would sincerely like to know…
WHY did those tests show the results that they did?
WHAT was the result of your investigation into the matter,
WHY IN 7 MONTHS hasn't there been a single document produced to answer that question.
Interestingly enough, when asked how many calls he had inquiring as to his testing method, the owner of Mineralogy said 'none'. NONE! Nobody called him to ask how he did the test!! How, then, can the company claim that the test was done wrong?!
How can the company claim they abide by strict GMP regulations, when it appears that part of GMP is to have a process in place that investigates consumer complaints, and HOW can a consumer investigation in this case have taken place without first calling the lab to verify testing methods?
I am not, nor have I ever said that your product Natural Cellular Defense does not (or did not) meet label claims. I have also never said it doesn't work.
I am simply asking… when you investigated the matter, what were you able to find that explained the results of those 2 independent tests? If you did NOT investigate, then how do you know the test was done incorrectly?
I believe this to be a reasonable request, particularly in light of the fact that, in reference to the Natural Cellular Defense (NCD) product, there have now been "Over 3.5 MILLION bottles sold" as stated on Waiora's Marketing materials.
Interestingly, I routinely order a thyroid support supplement. Recently they had cause to question the manufacturing process of their product because customers "claimed it was ineffective for them". Based on JUST that, a few customer complaints that the product didn't work, here is the action THEY took! Thyrogold suspects there isn't enough active ingredient in their product
If I was the OWNER of any company, and I heard that there had been a test done by 3rd party labs, and I didn't have any reason to believe that the tests were correct, the first thing I would do would be to call the labs and verify the results. The second thing I would do is send my own specimen to be tested.I wonder why, in this case, that didn't happen?
source: FDA Dietary Supplements Law
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