Latest FDA Update regarding EOS Lip Balm
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1The latest update from FDA has to do with the reactions of people to EOS Lip Balm® and how is FDA going to act on this issue. Please read carefully the following announcement:
Some consumers have reported reactions to certain varieties of EOS Lip Balm®. The following information tells what FDA knows about these products, what we’ve done, what we can do, and what consumers can do if they have a reaction.
What Kinds of Reactions Have People Reported to FDA?
People have reported rashes around the mouth as well as blistering and cracking of the lips. Generally, people say that when they stop using the product, the symptoms go away.
How Many Reports Has FDA Received?
FDA received 58 reports between August 6, 2014 and January 28, 2016.
Have These Reports Named Specific Varieties?
Consumers have reported reactions to the following varieties of EOS Lip Balm®:
Sweet Mint, Honeysuckle Honeydew, Summer Fruit, Strawberry Sorbet, Passion Fruit, Lavender, Pomegranate Raspberry, Indian Summer Orange Blossom, Aloha Hawaii Strawberry Kiwi, St. Barth’s Sunrise Pink Grapefruit, Vanilla Mint, and Coconut Milk.
Does FDA know what caused the reactions?
No. We don’t have enough information to determine the cause of these reactions. The law does not require cosmetic companies to share their safety data or consumer complaints with FDA.The complaints that have come to FDA have not provided enough information to determine why some consumers experienced reactions when they used these products.
What is FDA doing about these reports?
FDA contacted EOS and inspected the contract manufacturer where the EOS Lip Balm® products are made. We found some violations related to good manufacturing practices (GMP), but these do not appear to explain the reports we’ve received.
The contract manufacturer that makes the products for EOS has taken action to correct the cosmetic GMP violations identified by FDA and is now in compliance. However, we are still receiving reports from people about reactions they’ve experienced when they used various EOS Lip Balm® products.
If we learn of new safety information about these products, we will make it publicly available.
What should consumers do if they have a reaction?
If you have a reaction when you use an EOS Lip Balm® or any other cosmetic, first stop using the product. Next, contact your doctor or other healthcare provider for medical advice. Then, please tell FDA. You can report a problem related to EOS Lip Balm® or any other cosmetic in two ways:
- Contact FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088.
- Contact your nearest FDA district office consumer complaint coordinator.
When you report your problem to FDA, please provide as much detail as possible about the specific product you used and your reactions. The more we learn about EOS Lip Balm® and the reported problems, the better we can determine what action FDA should take under the laws we enforce.
FDA can take action against cosmetics on the market that don’t comply with the law for either safety reasons or mislabeling. For example, we can issue a warning letter. In some cases we can work with the Department of Justice to seize a product, in order to keep it off the market. While we can’t order a recall of a cosmetic, we can request one, and we work with companies to make sure their recalls are effective.
To take action for safety reasons, FDA must have sound, scientific evidence showing that a cosmetic is unsafe when consumers use it as intended. At this point, based on the limited number of reports we have received, we don’t have that kind of information about EOS Lip Balm®. To learn more, see FDA Authority Over Cosmetics.
