1997 FDA Notice

Many of you have seen the notice that states:

“FDA WARNS AGAINST CONSUMING THE ARISE & SHINE PRODUCT "CHOMPER"
Dated May 16, 1997.

We would like to thank the FDA for posting this notice; we think it helped a few people find us when they needed to find us 11 years ago in May 1997.

In case you are wondering what happened, most importantly please understand that this was an incident limited to only 2 batches of Chomper with clearly marked lot numbers. Those lots were D6409 and a series starting with 703xxx, such as 703118.

We do not know why, 11 years later, the notice still appears and appears without the lot numbers. The FDA acknowledged that they were satisfied with results of our recall.

So for those of you who are wondering what happened to cause a recall, here it is in a nutshell. Know that what ensued because of this recall was quite an education:

With the help of the FDA it was discovered that one of the raw materials (plantain) supplied to Arise & Shine and subsequently manufactured into Chomper was contaminated. Unfortunately, the company's contract manufacturers were not delivered what had been contracted for purchase; pure wild crafted domestic plantain. Instead we were delivered imported plantain marked as domestic. Sadly, we were among 160 companies in 1995 and 1996 to receive this contaminated material. To this day no one has ever been able to tell us how the plantain came to be contaminated with digitalis, a substance that is not used in the herbal trade. It had to have been already contaminated when it entered this country as the offending species of digitalis is grown in Europe and is only found as a specimen plant domestically. If you know how this came to be, please write us.

At that time the company only tested for pathogenic bacteria, yeasts and molds. No one had ever heard of domestic plantain being contaminated with digitalis and so we didn’t test for it. Today we do, no matter the stated country of origin. And, of course there are many, many other quality tests that we perform to assure our customers, family and friends only the highest of quality products.

If you have any questions, please feel free to contact us. Thank you for your support and interest in Arise & Shine.