Teething and Chewing  Necklaces Under FDA Warning – How to Find the Safest Oral Sensory Tools.
Child chewing her hair needs SAFE outlet for urge to chew from a Sensory Box.
FAMILIAR?

The scenario is that teething and chewing necklaces are now under FDA warning. But, after trying alternatives and OT behavior techniques, your child still chews everything! Now what? How do you navigate the chewy minefield? Are there products safer than pencils, sleeves and household items? How do you find them? I felt this way in 2006 and this article revisits all the reasons why our company exists.

The FDA Warning: Chew and teething Necklace Products are unsafe warns the U.S. Food and Drug Administration (FDA)

In 2006, my sensory seeking middle child inspired my company SentioLife Solutions Ltd, co-owned with my retired teacher mother, and the design and creation of KidCompanions Chewelry and SentioCHEWS. The research and testing behind these was extensive but at the same time my fear of unsafe/untested materials and imports increased.

There are standards, rules and regulations to follow for products that are for or aimed at children. Material safety, structural safety, instruction sheet information and labelling/ packaging details, even liability insurance is distinct (and expensive). I am a Canadian mom with a background in human kinetics and jewelry design. Circumventing any requirement was never considered, let alone an option. Then, there are voluntary standards that have to be considered.

So what was the FDA Safety Communication warning?

In summary, “the FDA is alerting parents, caregivers, and health care providers that necklaces, bracelets, and other jewelry marketed for relieving teething pain should not be used with infants or to provide sensory stimulation to persons with special needs, such as autism or attention-deficit/hyperactivity disorder. Such use could lead to strangulation, choking, serious injuries, or death. The safety and effectiveness of teething jewelry to treat teething pain and/or provide sensory stimulation have not been established.”

The FDA even goes as far as to recommend that Health care providers “Discourage use of necklaces, bracelets, and other jewelry for providing sensory stimulation to people with special needs.“. The full article.

With the boom of food grade silicone, wood and amber teething necklaces we have seen since our launch in 2007, I am sadly disappointed, though not surprised, that injuries have occurred. I was even approached (multiple times) by international (China) companies promoting “wholesale prices” for bulk chewable jewelry, packaged and ready-to-sell.

I am going to address the above products before I write about our own products.

While developing our products, we learned that there are many regulations and standards. We also learned that some sellers are not even aware of these and the regulation bodies do not have complete control of what we can buy in brick and mortar stores and online (especially online). So, as consumers we have to read labels and even research a product before we buy.

AMBER:

Firstly, amber. As I mentioned before I have a background in jewelry design, a Gemological Institute of America AJP diploma and 10 years as a jewelry designer. I have imported baltic amber and have worked with it. Baltic amber does indeed have Succinic acid (the “analgesic substance”), however, a lot of “amber” is reconstituted, fake or covered in resin or other material.

amber teething necklaces
Bulk Chinese import on Alibaba (plastic jewelry category?). It could be unclear where the amber teething necklaces material originates.

Furthermore, Succinic acid melts at around 187 °C and there’s only a slight chance of some being dissolved by sweat. In other words, an infants warmth will not magically “release” Succinic acid from amber. Finally, there’s the fact that it’s used as a food additive though its safety hasn’t been widely tested. We are still only at the amber.

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Amber “teething necklace” with screw clasp and possible “natural” (but hard) amethyst

Personally the breakaway featured on the necklaces is my biggest red flag. Some are screw clasps and some are imported “pop” or breakaway clasps that can have varying release strengths and putting a cord around the neck of an infant with that unknown is not safe. Obviously, little beads attached to one another with a cord could possibly be unattached with mouthing, releasing little beads for aspiration. Parents and caregivers have to read the packaging and instruction details. (BUT! The product, label and instruction sheet have to follow the rules and regulations of the importing country… and there’s the rub).

SILICONE

Next, silicone imports. These have popped up everywhere and come in a variety of shapes, colours and sizes. We, inside our little world of chewing necklaces, call these “the knock-offs”. Sometime between 2010 and 2012 they seem to have taken over the world and along with all the other non-recyclable silicone products will be clogging up the planet for the foreseeable future. I would never let an infant wear one of these due to the unknowns; breakaway strength, nylon dyes, silicone and colorant testing. The final word on these is that they are imported, copied and produced in bulk.

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Example of food grade silicone pendants available for bulk import from China.

Often branded with custom logos and attached to nylon cords with black/silver/white/gold oval breakaway clasps. They can be donuts, dog tags, elephants, cars, oreo cookies, shark, etc.. Some are solid colours and some have accents. Unless they are tested per imported batch, you don’t know what’s in them! Especially the colorant and “accent bits”. FDA Food Grade, are we sure? Let’s remember the Nestle scandal shall we?

NATURAL

Hevea Panda Teether

Lastly, “natural” materials. Before designing my own, this category was my go to. I would stress that the products should be labelled and follow “Toy Safety” regulations if aimed at toddler use. Wood and natural rubber teething toys are indeed natural but can come with their own issues. Natural rubber would be dangerous for latex allergies and wood can develop splinters or be made of wood with oil that leaches unsafe substances. For teething, “teether sized” would be important, as opposed to “imitation jewelry, use under supervision”.

2 month old with my handmade "Newborn HeartString"
2 month old with my handmade “Newborn HeartString”. Helped her focus on the task!

The story of our two lines of chewing necklaces is a story about finding a SAFER chew for a child, not cutting corners and following safety rules.

6Mo-chewelry

Original clay pendant, dubbed our baby’s “HeartString” before being appropriate by sister.

Since 2006 and still today, as a mom and entrepreneur, I design, manufacture, label and package our chewable pendants in Canada for all the above reasons. The following is our story.

Four year old wearing mommy’s “HeartStrings” (baby sister’s nursing necklace) used as oral sensory tool, instead of chewing sleeves.

About twelve years ago, I noticed our middle child was constantly chewing on her shirts, other items, her fingers and the inside of her cheeks. She took to a homemade clay pendant I had made for her breastfeeding baby sister. Once I realized it was sensory issues that were distressing my four year old, I looked for but could not find a stylish “safe chewable” that she would want to wear and use at school.

Part of the Small Parts Test for the KidCompanions Chewelry Insert (even our hard center passed this test)

Teaming up with my mother and a creative cousin for ideas, we developed a design and pitched the product at a start-up competition, beating out other competitors to win enough for development costs! We partnered with the Product Research & Development Group at Dalhousie University in Halifax, NS. After lots of design, research, testing and prototype manufacturing time, we finally had a safe, chewable pendant and a proprietary breakaway clasp that conformed to standards worldwide. Our material was FDA approved, our shapes tested for US, Canada, EU and AUS size (Small Parts) standards, and contained materials that were carefully sourced. We 3rd Party tested our pendants and are CPSIA Compliant. Still hallmarks of our products today!

One of the first KidCompanions Chewelry being made. (Translucent because we had not used colorant)

The same research went in choosing comfortable, cotton lanyards. Our first line of safe chew necklaces, KidCompanions Chewelry (with tactile features and 2 colours) was ready for market in 2007 and and our second line (for more aggressive chewers in one economical shape) launched in 2013.

KidCompanions Chewelry Features

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KidCompanions Chewelry
  • KidCompanions Chewelry is CE marked to EU standards, under the Medical Device Directive.
  • Chew Pendants are 2 fused parts and made of thermo-plastic elastomers, both medical grade, USP Class VI.
  • Chew Pendants and clasps are made-in-Canada in a medical device, ISO certified facility
  • Our lanyard lengths follow ASTM standards for children’s safety of cords and loops.
  • The breakaway is custom-designed to ASTM standards and made of FDA approved Polymer. (*These are available for ALL our pendant shapes as they are available in many lengths and always have our special safety clasps, tested to Toy Safety standards (cords and loops))
Our custom breakaway lanyards.

Durable SentioCHEWS – Tough, FDA Safe & Economical!

A few years ago, parents asked us for a more durable chew pendant with a longer lanyard for their older, active kids. After months of research and development, in Nov. of 2013 we launched the Tougher-than-Silicone” SentioCHEWS. Focus groups made up of kids and adults helped in the design of four chew pendant shapes available in red or blue. SentioCHEWS are made with the same safety features as our first line of chewing necklaces.

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SentioCHEWS

Unique SentioCHEWS Features

  • Chew Pendants are 1 part and made of thermo-plastic elastomers, FDA Food Grade Approved.
  • SentioCHEWS not only pass the “Small Parts” choking hazard test, but they pass the teether test size.
  • Our lanyard for SentioCHEWS are made-in-the-USA tactical paracord. They are tough and for active youth.*
  • SentioCHEWS are more economical than KidCompanions Chewelry because they are easier to mold and only use one material.

Features of TPE (Thermo-Plastic Elastomer)

People sometimes mistake our products for silicone. We did test food-grade silicone and found that TPE is a better Chewelry material alternative, for the following reasons:

  TPE is better for environment (easier recyclability) than silicone (cannot recycle silicone).
  Our TPE had better weather and environmental resistance than silicone
  There is better tear resistance in our TPE (especially the thick SentioCHEWS Chubby Star)
  TPE is more stretchable, can have a “grippy/rubbery” feel (like our SentioCHEWS) and can be easily reused. That’s right, excess or left overs can be reused and made into other cool things!

Important Safety Notes about our chewelry.

Like any chewable/mouthable item (soother, teether, oral sensory tools) SentioLife Solutions Chewelry will eventually wear due to daily use. Frequent adult inspection for tears or damage is required. Discarding and replacing the item is then suggested. Chewing clasps is never recommended.

KidCompanionsLight-moderate chewers – Average use is 4-6 weeks or 3 months + if used as a fidget or as an addition to other chewables. Moderate-heavy chewers – Average use is 3-5 weeks or less, depending on chewer.

SentioCHEWSModerate-active chewers – Average use is 3-5 months or 6 months + if used as an addition to other chewables. Moderate-heavy chewers – Average use is 6-9 weeks.

Pendants will be damaged sooner with aggressive chewing or if an individual chews selectively (on certain spots). We aimed at making a product that is non-toxic, durable but that can’t damage teeth. Recommended for ages 3+ *KidCompanions: The hard interior plastic prevents large parts from breaking off and causing a large choking hazard-sized chunk and the materials are FDA USP-IV medical grade. In the event a child does ingest little pieces, they should just pass through the digestive system without harm. *SentioCHEWS: The one-part shape is larger than our 2-part KidCompanions and passes teether size recommendations. Children should always be monitored when using chewables.

References:

Succinic acid (butanedioic acid) is a dicarboxylic acid that occurs naturally in plant and animal tissues.
Amber teething necklaces: a deadly form of maternal micro-branding https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm628900.htm