- 1 A brief explanation on the FDA List of Inspection Observations and 483s
- 2 What about Mira Health Products, the manufacturer of the potentially adulterated supplements?
- 3 What’s your point, PricePlow?
- 4 References
Purity First is finally recalling two lots of the B-50, one lot of the multi-mineral, and all lots of Vitamin C.
Hot off the heels of the USA Today article about Matt Cahill and Driven Sports came more bad press for the supplement industry this week:
The FDA issued a news release and warning about Healthy Life Chemistry by Purity First, whose Vitamin B-50 supplements may contain traces of two unlabeled anabolic steroids, methasterone and dimethazine.[1,2] The vitamins were manufactured by Mira Health Products Ltd. in Farmingdale, N.Y.
We did some research and found something extremely interesting: The FDA inspected and warned Purity First exactly a year before this scandal broke, meaning that all of this could have been prevented.
Before we get into the details of the problem (along with our suggested solutions), let’s discuss some research tools:
A brief explanation on the FDA List of Inspection Observations and 483s
Deep inside of FDA.gov lies the relatively unknown FDA List of Inspection Observations, which is an annual report linked and explained on the FDA’s site.[4,5]
The list contains each year’s “483” reports:
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
However, the 483 FAQ goes on to state:
The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations…. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.
This essentially means that a citation/observation in the form of a 483 does not always require mandatory corrective actions by the manufacturer, which may be making food, medical devices, drugs, supplements, or other health-related products.
On the citations list, which you can download at source , you’ll see a column titled CFR. This is the Code of Federal Regulations, which can then be looked up. We’ll cite the one related to this ordeal.
Now on to the Purity First infractions at hand:
Healthy Life Chemistry by Purity First already Inspected and Warned
With this research in mind, look at what happened a year prior to the Purity First B-50 warnings:
|Firm Name||City||State||Country||Insp End Date||Center||CFR||Long Desc|
Healthy Life Chemistry Inc., dba Purity First
21 CFR 111.475(b)(1)
You did not make and keep written procedures for holding and distributing operations.
Healthy Life Chemistry Inc., dba Purity First
21 CFR 111.75(c)
You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition, and limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement.
The second citation is the one that concerns us: Purity first did not prove batch tests during their 2012 inspection. Below is the exact guideline:
(c) For a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), you must verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement. To do so:
(1) You must select one or more established specifications for identity, purity, strength, composition, and the limits on those types of contamination that may adulterate or that may lead to adulteration of the dietary supplement that, if tested or examined on the finished batches of the dietary supplement, would verify that the production and process control system is producing a dietary supplement that meets all product specifications (or only those product specifications not otherwise exempted from this provision by quality control personnel under paragraph (d) of this section);
(2) You must conduct appropriate tests or examinations to determine compliance with the specifications selected in paragraph (c)(1) of this section;
(3) You must provide adequate documentation of your basis for determining that compliance with the specification(s) selected under paragraph (c)(1) of this section, through the use of appropriate tests or examinations conducted under paragraph (c)(2) of this section, will ensure that your finished batch of the dietary supplement meets all product specifications for identity, purity, strength, and composition, and the limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the dietary supplement; and
(4) Your quality control personnel must review and approve the documentation that you provide under paragraph (c)(3) of this section.
TL;DR: had this been followed, nobody would have received steroids with a Vitamin B-50 label on them.
The one major thing that we don’t know is whether or not the potentially adulterated B-50 vitamins were manufactured before or after this FDA inspection, so we are unable to draw further conclusions as to the intent and criminality of this latest scandal.
We are also not sure when the adverse event reports (AERs) began, nor do we know if that is what initiated the 2012 inspection. It seems that the 2013 inspection may have been a follow-up to the one in 2012.
Can I see the full inspection report?
Currently, it is not available. The FDA does not have to publish this data[source required] unless there is a Freedom of Information Act Request (FOIA), which can be done via the FDA’s website.
Who were the FDA inspectors?
FDAZilla lists Sarah Wangseng and Ann Stewart as the inspectors[9,10]. We have reached out to these individuals for comment.
As far as we can tell from this information, the FDA only inspected Purity First twice.
What about Mira Health Products, the manufacturer of the potentially adulterated supplements?
What’s very troubling about our investigation is the incredible lack of information of the actual contract manufacturer of these supplements, Mira Health Products.
Their website is now conveniently under construction, and that’s about all you’ll find, save for a Google Street View of their address of their office. They are listed alongside Purity Health in the 2013 inspections lists.[9,10]
If any of our readers are in the Farmingdale, NY area and have more information, you can anonymously contact us or leave a comment below.
Not Doing Voluntary Recalls?!
Further, what’s most troubling is that these companies have decided against performing a voluntary recall. This will undoubtedly draw severe ire not only from the consumer base, but from the FDA as well.
Update – August 1, 2013: These products will now be recalled:
- B-50, 100 capsule bottles, lot numbers F03Q and C02R
- Multi-Mineral, 200 capsule bottles, lot number 12-829
- Vitamin C, 200 capsule bottles, lot number E03Q
It was extremely disappointing to see these companies refuse to attempt recalls at first.
What’s your point, PricePlow?
Besides providing additional information that major media outlets did not uncover, there are a few major points to this article, along with a few upcoming solutions:
It’s not the laws — it’s the enforcement
As mentioned in our Driven Sports article, the common knee-jerk reaction of “we need more regulation!” is not exactly the answer.
Once again, it is shown that the laws, guidelines, and inspection processes were in place. However, the enforcement, or lack thereof, was once again a problem.
There are a great deal of law-abiding, ethical companies in this industry, and we enjoy working with them. We do not see a need for more “blanket laws” when the existing policies in place could easily target criminal activities… if they’re enforced.
From what we understand, the FDA is currently focusing on manufacturers. Forcing them to implement proper GMPs could effectively nip this in the bud.
Publicly available information is a decentralized messIt shouldn’t be this hard to find important information about the people, companies, and manufacturers behind your favorite supplements.
We deal with this stuff every day, and it was still a pain in the neck for us to find some of the stuff listed here (and we still know next to nothing about Mira Health).
Soon, we’ll be proposing an IT-based solution, but it will require technology that is still in the midst of our development. But first, consider this: the FDA gave nearly 24,000 citations to 5,400 companies — many of which had nothing to do with supplementation. Properly filtering and linking this would be a massive undertaking.
There simply needs to be a bit more transparency behind these companies, which leads us to our next suggestion:
Partial Solution: Consider forcing supplement companies to disclose their contract manufacturers
Depending on how this all shakes out, consumers may not want to purchase anything else made at Mira Health’s Labs (shown in image above).
Currently, it is impossible to state what products in your cabinet were manufactured by them, or any company that is working alongside Purity First.
This a glaring issue that a relatively simple label requirement change could solve.
All it takes for evil to triumph is for good men to stand by and do nothing
It’s painful to watch an entire industry kill itself because we can’t control a handful of clowns. If we don’t do it ourselves — and do it soon — you can be damned sure that the FDA will.
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- Citations List – http://www.fda.gov/iceci/EnforcementActions/ucm250720.htm
- Form 483 FAQ – http://www.fda.gov/ICECI/EnforcementActions/ucm256377.htm
- 21 CFR 111.75(c) – http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=111.75
- Reading the Citations List – http://www.fda.gov/ICECI/EnforcementActions/ucm250729.htm
- FDA Freedom of Information Act Request – http://www.accessdata.fda.gov/scripts/foi/FOIRequest/requestinfo.cfm