The FDA conducted an inspection of Young Livings’ website as well as several consultant’s social media accounts (Instagram and Facebook) and found several violations in regard to claims, branding, and illegal products in the marketplace, all of which is discussed in the warning letter released.
So now let’s dive into the violations listed.
- The FDA also stated that there were misbranding violations during their inspection of websites and social media accounts. Namely it focused on drug-related claims, unapproved- new drugs, and CBD.
- Several of the consultants utilized drug like claims to market the essential oils, Ningxia, and CBD product. Examples of such claims included
- “Ningxia – scientifically proven to be the highest antioxidant food source in the world…Inflammation, disease, and cancer are all driven by Free Radicals…Antioxidants neutralize free radicals, meaning they stop them from doing damage… reduced inflammation, healthy cholesterol and blood sugar.”
- “Lemongrass poses a very strong argument for being the ‘go-to’ when you find yourself not feeling well, battling inflammation, infection, stomach upset, stuffy sinuses…high body temps…high blood pressure, high cholesterol…If it’s stomach upset, bladder discomfort, cholesterol, or blood pressure that we are looking to improve, we ingest.”
- “What does CBD oil support? . . . addiction . . . Alzheimer’s . . . anxiety . . . chronic pain . . . depression . . . diabetes . . . drug withdrawal . . . epilepsy . . . glaucoma . . . inflammation . . . insomnia . . . Parkinson’s . . . sleep disorders . . . plus more! . . . Coming Soon, Young Living CBD Oil”
- The websites of both Young Living and their brand partners Nature’s Ultra had misleading drug like claims such as follows
- “Some studies suggest [t]he most common illnesses caused by an improperly functioning ECS are depression, Alzheimer[’]s, IBS, fibromyalgia, and even migraines . . . [t]hat’s why it’s so important to ensure that you are supporting it as needed . . . CBD [an ingredient in your Nature’s Ultra CBD Beauty Boost, Nature’s Ultra CBD Muscle Rub, Nature’s Ultra CBD Pep Bundle, Nature’s Ultra Calm CBD Roll-on, Nature’s Ultra Cinnamon CBD Oil, Nature’s Ultra Citrus CBD Oil, and Nature’s Ultra Cool Mint CBD Oil] is a great way to support your ECS . . ..”
- Several of the consultants utilized drug like claims to market the essential oils, Ningxia, and CBD product. Examples of such claims included
The FDA concluded that based on the above claims and many others cited in the letter, that Young Living was producing “drug” products and had not fulfilled the proper requirements and forms to do so. Specifically their CBD product line is considered a nonprescription drug and would require an application and approval to legally be sold on market.
Many companies believe that their regulatory risk ends with a packaging label and that is not so. Your websites, branding, and social media accounts are all reviewed for compliance. As we live in a day and age where many companies are using “consultants” or “brand ambassadors” it is important that they are as well aware of the regulations and legal liabilities that can come into enforcement in an inspection.
To read the letter in full, click HERE.
If anything in the letter sounds familiar from your facility, or you would just like to be better prepared for your own FDA inspection when the time comes, let us know. In addition to label compliance reviews, we do facility audits and consulting on following cGMPs. Contact us today to discuss your needs and get a free quote.