CBD Oil For Baby Teething

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The U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved products containing cannabidiol with unsubstantiated claims. Any parent who has tried in vain to soothe a child suffering from a painful ear infection or comfort a teething baby knows that feeling of… There's a lot of talks about the benefits of CBD oil, but is CBD oil safe for children? How about for babies? Read about CBD Oil for Teething.

FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease

FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

Today, the U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.

“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance. We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children,” said Acting FDA Commissioner Ned Sharpless, M.D. “We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements. As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority. We appreciate the FTC joining us on these and other actions to protect consumers from fraudulent CBD products.”

As described in the warning letter issued to Rooted Apothecary, the company used product webpages, through its online store and social media websites, to make unfounded claims about its CBD products, and some of the products were also unlawfully marketed as dietary supplements. The agency has determined that CBD products cannot be marketed as dietary supplements.

Examples of the unsupported claims made by the company include:

  • “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
  • “No matter what age, ear aches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame.”
  • “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
  • “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
  • “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”

Additionally, under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. The FTC is concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. These products are also misbranded under the Federal Food, Drug, and Cosmetic (FD&C) Act, because the products’ labels and product information fail to include adequate directions for use. Drugs in the United States must contain directions explaining how a consumer can use a drug safely for its intended purpose. Under the law, there is an exemption for this labeling requirement for prescription drugs that have FDA-approved applications in effect. However, none of Rooted Apothecary’s products are FDA-approved.

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The FDA and FTC have requested responses from Rooted Apothecary within 15 working days stating how the company will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or administrative cease and desist order, and an order also may require that a company pay back money to consumers.

The FDA continues to be concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the agency. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.

The FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products while maintaining the FDA’s rigorous public health standards.

“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products. We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.”

Unlike drugs approved by the FDA, the manufacturing process of unapproved CBD products has not been subject to FDA review as part of the drug approval process. Further, there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. Consumers may put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products. For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.

The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

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The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Joint Warning Letter Targets CBD Claims Relating To Infant and Child Uses
Blog Cannabis Law Update

Any parent who has tried in vain to soothe a child suffering from a painful ear infection or comfort a teething baby knows that feeling of desperation when you may be willing to try just about anything to get the crying to stop. Both yours and the child’s…

It is just this issue that appears to have caught the attention of the FDA and FTC as the target for their most recent CBD enforcement. Similar to the three CBD companies previously targeted, Rooted Apothecary made allegedly unsubstantiated claims that its products could prevent, diagnose, treat, or cure serious diseases. Particularly concerning this time, however, was the fact that some of the claims targeted use on infants and children.

Some examples of the company’s claims included the following:

  • “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
  • “No matter what age, ear aches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame.”
  • “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
  • “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”

Once again, CBD marketers should take a lesson from the rules that apply to conventional products, and not just as to claim substantiation. Product claims that target vulnerable populations, such as infants, children, or the elderly, are likely to receive greater scrutiny regardless of the product type. These populations (along with sleep-deprived parents of young children) may be more susceptible to believing outrageous claims and less likely or able to articulate it if a product is not working or is potentially causing harm. And that – more than the ear infection – is reason for concern.

CBD Oil for Teething

WARNING: There is *limited* research showing that using CBD Oil for young children is safe. Some Doctors are cautioning against using CBD Oil for young children. Please consult with your pediatrician before trying any new drug on your children.

You may not be a stranger to the wonders of CBD oil. It has many beneficial effects on the body and may also be used as a treatment for mild to severe illnesses.

But, is it safe to use for young children and babies?

Babies and toddlers may also experience discomfort and illnesses like adults.

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One of the challenges babies and parents undergo is the teething phase.

It could make most babies irritable and experience swollen gums. Usually, teething problems go away on their own.

But sometimes, babies could have a case of swollen and itching gums which can affect their moods and sleep.

There are many ways to relieve teething babies from their agony.

But nowadays, many parents are curious if CBD oil can help soothe the inflamed gums of their little ones.

Let’s find out if CBD oil for teething is possible and safe for babies.

Table of Contents

Safety of CBD Use for Children

The opinions about using CBD for children are divided among parents and experts.

Some parents believe that CBD has great effects on their children suffering from different illnesses and even autism.

But, there are parents who are also skeptical. Some believe that CBD can make their children “high” or “addicted” to CBD.

To clear this misconception, THC and CBD are completely different.

THC is the cannabinoid that makes someone “high”. CBD contains the benefits coming from the hemp plant.

It may be safe to say that CBD products like CBD oil are safe for kids as long as it doesn’t contain THC and comes from hemp.

Is CBD Safe for Children?
There is no evidence that the CBD products on the market are safe or effective for children.

The FDA has only approved one CBD product, a prescription drug called Epidiolex that treats seizures associated with certain types of epilepsy in patients older than 1.

Epidiolex has been studied in clinical trials.

While it has proven to be effective at reducing seizures, it has shown significant risks and side effects including:

Elevated liver enzymes
Decreased appetite
Tiredness
Sleepiness
Malaise
Sleep problems
Increase in suicidal thoughts
Interference in how other medicines including propofol, bupropion, morphine, clobazam, lorazepam, and phenytoin work

WebMD

CBD Oil Legality

CBD oil from hemp is legal in all 50 US states and in some countries. However, CBD oil from marijuana plants isn’t completely legal.

If you want to try giving your child CBD oil, it’s best to check whether the product is hemp-based or marijuana-based.

Giving a child marijuana-derived CBD oil will get you into trouble with the law.

How to Give CBD Oil to a Teething Baby

Teething babies are already irritable and forcing them to take CBD oil might make them even feel worse.

The challenge with giving a baby CBD oil is the taste.

Some adults don’t like the taste and feel of CBD oil in their mouths. Some babies may not accept CBD into their mouths.

You may try mixing them with drinks or food, but it may also affect the taste of the food or drink.

Luckily, CBD oil with flavorings are available to make them more appealing to the taste.

But, you have to be careful with the ingredients contained in the product.

It’s best to buy CBD oil from vendors who are transparent with the ingredients they use.

Before giving CBD oil for teething babies, it’s best to consult your pediatrician.

But, most pediatricians aren’t aware and may not accept CBD oil as a treatment for children. You may need to find someone who is familiar with CBD.

Conclusion About CBD Oil for Teething

Parents only want what’s best for their children. Giving CBD oil is the parents’ prerogative.

But, it’s also the parents’ task to make sure that what they’re giving their kids are safe.

Before giving CBD oil to any child, research and consult a doctor to prevent serious problems.

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