What's up with the MFG 2019 date on Arthrosamine?

Long story short:   That Arthrosamine product officially Expires 12-2024.

For years we used a conservative 'three year' shelf life as our minimum. However, in 2017 the FDA issued a new protocol regulation on manufacturing: "There must be a ‘aging stress test’ on file, PROVING an EXPIRATION DATE on EACH PRODUCT (including each different bottle size and ingredient counts, even of the same product), and with everything inside the container (scoop, desiccant, excipient, etc. which may, or may not, impact the life of the product); only then can companies legally have an "EXP" Date on the bottle. Otherwise, they legally had to USE the MANUFACTURED DATE on the bottle (rather than EXP)."

While that made perfect sense [to us] for new products, it didn't make any [sense] on products that had been manufactured for over 20 years, didn't have 'proteins' or 'fats,' or other type of ingredients, which might normally limit the shelf life of a product. Especially when the product had a well established history and hadn't undergone any significant changes. Plus, that accelerated aging test was expensive, at over $2500 per product, per size (supposedly even more now); and, time consuming (they estimated about a 4 to 26+ weeks to complete... depending on the labs backlog, and that was IN ADDITION TO the 'manufacturing time.') This delay would have absolutely ran us (and, ultimately our customers) out of product, and likely would have required us to raise our prices. So, back in 2017, after much thought and deliberation, particularly since our then current product turnover was less than 18 months per batch, and the MINIMUM shelf life was well established at three years, we agreed to use their MFG DATE rather than undergo the additional delays, probability of running out of product, and endure the tens of thousands of dollars in expenses. An easy decision, knowing (at that time) we'd be reordering product at least 2 to 12 times over the next three years, depending on sales, so 'no big deal' (we thought).  

All of our products have a minimum of three (3) year shelf life from the date of bottling; AND, actually our joint, digestion, and complete formulas have tested out at up 5 to 12+ years when stored in a DRY, cool place, out of the sun light. Sunlight, moisture, and large fast temperature changes (that can cause condensation in opened containers) can reduce the potency and life of the product.  However, we hadn't had this 'new' test the FDA wanted, so, MFG date was what we'd go with at the time. Since we've had these very products since 1995, we are extremely knowledgeable about ingredients, packaging, shelf-life, and (at that time) SELL THROUGH/TURN OVER. 

It is our goal to KEEP STOCK ON HAND, especially key products, and never run out for our regular customers and resellers. We have also worked hard to keep MSRP (manufacturer’s suggested retail price) the same without sacrificing quality (or quantity). To achieve those goals, we have increased our order sizes, thus warehousing, and reduced our operating expenses (almost completely eliminating tradeshows, events, and advertising costs... relying on our resellers, customers, and over 25 year reputation).  Adding an additional expense just didn’t make sense at that time. 

Meeting the FDA's requirements was 100% semantics.

The product remained exactly the same, it just said 'MFG DATE' rather than 'EXP Date' - still at least three years (now officially 4.5 years) from the MFG Date, otherwise zero changes 'in the product.' In 2017 through 2020 it was no big deal... because we were having product made a few times a year. 

Then 2020 happened…

CLOSURES & LIMITS... 

That put most hospitals, clinics, surgeons, and even veterinarians on ‘curb site’ – ‘mail order’ – and ’emergency only’ in most geographical areas around the country;  so, products that normally turned over 1, 2, 3+ times a year was still kept in our cool warehouse, but was trickling out slower.

Clients that hadn’t spoke with us, or seen one of our previous emails about the difference [MFG vs EXP] and what it meant, were getting ‘confused’ and ‘concerned’ about the MFG DATE on the product, especially when they’d see the 2018 or 2019 dates on product they were receiving in late 2021. 

It's understandable, and we hope this page will help explain WHAT IS HAPPENING,  WHY, and also HOW WE KNOW that our products are still 100% perfectly great product, without any issue or quality problem; and the MFG Date stamp on a few remaining product are just the remains of a federal ruling change. Same great product! 

November 2021 we PURPOSEFULLY CHOSE to send off bottles to be tested to insure the safety and quality of the product for 'label integrity.' The contents matched the amounts listed on the label, AND the results came back CLEAN and CLEAR. The lab stated that we could extend OUR product expiration date on those products Manufactured in 2019 out at least another 1.5 YEARS from the original 3 years projected expiration.

This means the our 2019 Manufactured products are officially extended to 12/2024 (18 months longer). 

Once explained, those that had questions, understood; though a few expressed they much prefer the ‘expiration’ over ‘manufacturer’ date on products even if it cost them a little more money. Most didn't want a higher cost. The rest of the clients appreciated the price, quality of key active ingredients, and ‘dosage’ all remaining the same… 

In the future, as new product is manufactured, they will have an EXPIRATION DATE (as well as the lot number) in compliance with the new FDA regulations, rather than the MANUFACTURED date (which was required by previous regulations). 

  • We work on a FIFO (First In, First Out) system, so as the older product is shipped off… it will all be replaced with the new EXPIRATION DATE product.
  • Gluquestrian was the first, Canine 120ct has already been transitioned (also new label), and the 60ct Canine will be next.
  • Arthrosamine (capsules) will be last (though it’s good until December 2024, despite the 06/2019 MFG Date), we anticipate we'll be 'back to the EXP Date' on the bottles before the end of 2022, at current sales levels).
  • We don’t foresee any other changes to our product's quality, quantity, consistency, self-life, or packaging for many years to come.
  • We greatly appreciate those that have recognized the small changes. 
  • Questions are ALWAYS WELCOME

Please note: 

our uniquely proprietary product and custom formulas continue to be

  • manufactured in the USA,
  • by FDA inspected & approved manufacturers, that are
  • cGMP compliant (Certified Good Manufacturing Practices),
  • ISO 9600 registered (clean room, pharmaceutical quality) facilities.
  • Our products undergo THREE (3) different tests with each batch/lot: in bulk, after blending, and then randomly after bottling, to insure our products are containment free, the formulas are consistent, ratios as they should be, and purity without question.
  • Our product consistently tests out at (or usually above) label claims… even years after the manufacture date.

I hope that answers those type of questions, and addresses any concerns.

If there are ANY other questions, or concerns, please let me know.

Sincerely,

Terry Mercer
C.E.O. , MD’s Choice, Inc.
865-384-8556 (direct line)
800-628-0997 MD’s Choice  

    P.S. - please feel free to call, email, or communicate with us if there are any questions or concerns. 

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