Tom’s of Maine is a personal care brand well known for its use of natural ingredients, though a recent FDA report has identified some very undesirable contents they say are in the company’s products.
The FDA sent a warning letter dated November 5th, detailing data that suggests some of Tom’s toothpastes were contaminated with bacteria – a discovery that the FDA based on reported internal testing as well as an agency inspection in May of the company’s manufacturing plant in Sanford, Maine.
Most Read on IEN:
Specifically, the FDA points to several of Tom’s toothpaste formulas where they say water used for processing contains multiple types of bacteria, including those linked to infections of the blood, lungs and eyes.
The letter contains a very detailed breakdown of Tom’s failures and besides the bacteria, they report that an investigator observed a “black mold-like substance at the base of the hose reel” that was just a foot away from equipment that made contact with end products. This and other observations led the FDA to conclude that the company did not keep its plant in a good state of repair.
The FDA notes that, since water is a major ingredient in many of Tom’s OTC products, it is essential that the company employ a water system that is robustly designed, and that Tom’s “effectively control, maintain, and monitor the system to ensure it consistently produces water suitable for pharmaceutical use.” The company has the opportunity to respond to the issues by way of remedy.
The company, owned by Colgate-Palmolive since 2006, has blamed the presence of certain bacteria on “a laboratory error” though the FDA rejects that contention, saying the initial investigation stated no laboratory errors were identified.
Tom’s submitted a statement to CBS News, saying "We have always tested finished goods before they leave our control, and we remain fully confident in the safety and quality of the toothpaste we make."
The firm added that it has “engaged water specialists to evaluate our systems at Sanford, have implemented additional safeguards to ensure compliance with FDA standards, and our water testing shows no issues."
CBS News said the company added that it is making capital investments to upgrade the plant's water system.
Click here to subscribe to our daily newsletter featuring breaking manufacturing industry news.
WEBVTT
X-TIMESTAMP-MAP=LOCAL:00:00:00.000,MPEGTS:0
00:00.009 --> 00:04.690
Tom's of Maine is a personal care brand well
known for its use of natural ingredients.
00:04.940 --> 00:11.310
Though a recent FDA report has identified some
very undesirable contents they say are in the
00:11.319 --> 00:14.779
company's products.
The FDA sent a warning letter dated November
00:14.789 --> 00:21.000
5th, detailing data that suggests some of Tom's
toothpastes were contaminated with bacteria.
00:21.010 --> 00:25.850
A discovery that the FDA based on reported
internal testing as well as an agency
00:25.860 --> 00:29.430
inspection in May of the company's
manufacturing plant in Sanford Maine.
00:29.440 --> 00:34.840
Specifically the FDA points to several of Tom's
toothpaste formulas where they say water used
00:34.849 --> 00:39.790
for processing contains multiple types of
bacteria, including those linked to infections
00:39.799 --> 00:43.950
of the blood lungs and eyes.
The letter contains a very detailed breakdown
00:43.959 --> 00:46.759
of Tom's failures.
And besides the bacteria,
00:46.770 --> 00:51.849
they report that an investigator observed a
black mold like substance at the base of the
00:51.860 --> 00:56.669
hose reel that was just a foot away from
equipment that made contact with end products.
00:56.680 --> 01:01.419
This and other observations led the FDA to
conclude that the company did not keep its
01:01.430 --> 01:05.819
plant in a good state of repair.
The FDA notes that since water is a major
01:05.830 --> 01:08.629
ingredient in many of Tom's over the counter
products.
01:08.699 --> 01:14.169
It is essential that the company employ a water
system that is robustly designed and that Toms
01:14.180 --> 01:19.769
effectively control, maintain and monitor the
system to ensure it consistently produces water
01:19.889 --> 01:24.089
suitable for pharmaceutical use.
The company has the opportunity to respond to
01:24.099 --> 01:27.800
the issues by way of remedy.
The company owned by Colgate Palmolive since
01:27.809 --> 01:33.769
2006 has blamed the presence of certain
bacteria on a laboratory error though the FDA
01:33.779 --> 01:38.569
rejects that contention, saying the initial
investigation stated no laboratory errors were
01:38.580 --> 01:42.025
identified.
Tom submitted a statement CBS news saying quote,
01:42.044 --> 01:46.394
we have always tested finished goods before
they leave our control and we remain fully
01:46.404 --> 01:49.144
confident in the safety and quality of the
toothpaste.
01:49.154 --> 01:53.964
We make the firm added that it has engaged
water specialists to evaluate our systems at
01:53.974 --> 01:59.144
Sanford have implemented additional safeguards
to ensure compliance with FDA standards and our
01:59.154 --> 02:03.555
water testing shows no issues.
CBS News said the company added that it is
02:03.565 --> 02:07.675
making capital investments to upgrade the
plant's water system,
02:08.315 --> 02:10.024
Amanda.
Well, this is manufacturing now.
