• Here’s a look at past contamination-related recalls in the personal
care, as documented by the Food & Drug administration.
earlier this year, the Us Food and Drug administration (FDa) sent a
warning letter to Gemdo Cosmetics of valencia, Ca following an inspection its cosmetic manufacturing facility. the inspection (Dec. 8, 2014-
Dec. 23, 2014) was conducted in response to a Class ii recall of Juice
Beauty illuminating eye shadow products that were manufactured there
and found to be contaminated with Bacillus cereus, an ocular pathogen
that can cause rapidly progressive endophtalmitis and lead to possible
loss of vision or the eye.
subsequently, FDa also sent a letter to Juice Beauty about the issue
at its contract manufacturer. in the letter, FDa noted that Juice Beauty’s
illuminating eye shadow products are formulated with preservative sys-
tems other than the preservative systems listed under appendix C of
Compliance Program Guidance 7329.001. FDa wrote: “Because bo-
tanical and organic ingredients are particularly vulnerable to microbial
contamination, these ingredients should be afforded increased scrutiny
by cosmetic manufacturers prior to their use. enforcement action against
contaminated products, which may be caused by inadequate preserva-
tion, may be considered if FDa analytical data show the presence of
microbial contamination at such levels that it may render the product
injurious to users.”
in October 2014, Nutek Disposables, inc. initiated a nationwide
voluntary product recall of all lots of baby wipes that it manufactured
under the brand names Cuties, Diapers.com, Femtex, Fred’s, Kidgets,
Member’s Mark, simply right, sunny smiles, tender touch, and Well
Beginnings and sold at Walgreens, sam’s Club, Family Dollar, Fred’s,
and Diapers.com. after receiving a small number of complaints of odor
and discoloration, Nutek conducted microbial testing that showed the
presence of a bacteria, called Burkholderia cepacia (B. cepacia), in
some of the products. the company initiated a voluntary withdrawal of
lots that had tested positive for the bacteria, as well as other baby wipes
in the surrounding time frame.
Back in 2013, W.s. Badger Co. inc. initiated a voluntarily recalling all
lots of its 4oz sPF 30 Baby sunscreen Lotion and one lot of its 4-oz sPF
30 Kids sunscreen Lotion due to microbial contamination. the products
were tested and found to be contaminated with Pseudomonas aeruginosa, Candida parapsilosis and acremonium fungi.
“as a father and grandfather, the safety and well-being of children
is my highest priority,” said Badger founder and CeO Bill Whyte back
when the recall was announced. “all of these lots passed the required
microbiological and comprehensive challenge testing prior to sale. it was
during routine re-testing that we discovered that the preservative system
in several lots had been compromised.”
according to Whyte, the voluntary recall is was the first in the com-
pany’s 18-year history.
More recently, in enforcement reports released this spring, Gilchrest
& soames and sensible Organics initiated recalls due to similar issues.
Gilchrest & soames recalled several brands of shampoo, conditioner
and bath and shower products because the products may be contaminated with Psuedomonas aeruginosa and enterobacter gergoviae.
Beaver Falls, Pa-based sensible Organics’ recall centered around mold
found in certain lost of Nourish Organic Face Lotion (argan & rosewater
and argan & Pomegranate varieties).
technologies. these technologies and methods include using the
formulation approach to preservation, incorporating strategies to
lower or eliminate the amounts of traditional preservatives or using hurdle technology,” noted Fana makonnen, area sales manager at inolex.
Since 2008, inolex has offered an innovative hurdle technol-
ogy under the Spectrastat CHa range. this multi-mechanism
system is a blend of a unique, patented chelating agent capryl-
hydroxamic acid (CHa) with an assortment of alcohols and gly-
cols. the range includes optimized Systems, Budgeted System
and Liquid Series, which is ideal for cold processes. according to
makonnen, the Spectrastat CHa range contains no biocides or
typical preservatives. instead, it uses multifunctional agents that
have excellent efficacy as biostatic and fungistatic agents. it is
ideal for formulations where a paraben-free or preservative-free
claim is needed. it performs superbly at neutral pH, a state where
many other fungistatic materials are ineffective.
inolex recently expanded the CHa range with Spectrastat
PHL and Spectrastat BHL, which were unveiled at in-Cosmetics
in Barcelona. these ultra-mild, high-performing alternative
preservative systems are ideal for sensitive facial applications,
where low irritation is required, such as dermatological and
pharmaceutical type products. the low irritation characteristics
can be attributed, according to makonnen, to the 6 carbon chain
length glycol used in these blends which has less membrane in-
teraction and therefore causes less irritation compared to other 8
carbon chain length glycols. Eight carbon glycols are more lipo-
philic, with greater attraction to membrane lipid bilayer of skin
according to inolex, Spectrastat BHL and Spectrastat PHL,
which are a complete system for preservative-free cosmetic and
personal care products, are especially useful in high water, cold-
process applications like toners, surfactant systems, and wet
wipes, and are completely liquid, homogeneous, and pumpable
even at low temperatures.
at the new York Society of Cosmetic Chemists Suppliers’Day
in may, Vertellus showcased CPC, a cost-effective and safe in-
gredient to preserve cosmetic formulations. manufactured under
cGmP conditions, CPC (inCi: Cetylpyridinium chloride) is an
active ingredient in leading oral care products.
With a long safety record, and multiple formulating benefits,
including low-dosage, broad spectrum efficacy and a favorable
environmental profile, CPC is an attractive alternative for formulators. the launch of CPC as a preservative is in response to the