Recipient NameMalin R. Sickelton
- The Body Bean, LLC
1314 Crown Way
Paso Robles, CA 93446-1829
- Issuing Office:
- Center for Drug Evaluation and Research | CDER
February 6th, 2023
RE: WL 2474
Dear Mr. Sickelton:
The United States Food and Drug Administration (FDA) has reviewed your firm’s drug registration and listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug product, The Body Bean’s Hand Sanitizer - Scented. Our review revealed that you are manufacturing a hand sanitizer for U.S. commercial distribution for which you have not registered your establishment and listed your drug product with the FDA. As such, your firm is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as explained below.
We note that FDA previously sent you and your firm a letter on this same subject, on October 21, 2022, notifying you of your failure to register your establishment and list your drug product. Even after such notice, the registration and listing data have not been submitted to the agency.
Under section 510(j) of the FD&C Act, and 21 CFR Part 207.17(a) and 21 CFR 207.41(a) of FDA regulations, with some limited exceptions, firms that manufacture, prepare, propagate, compound, or process drugs in the United States or that are offered for import into the United States must be registered with the FDA (21 U.S.C. 360(b), (c), (d), and (i)). Every person who is required to register must, at the time of initial registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution (21 U.S.C. 360(j)(1)). You have failed to fulfill your establishment registration obligations as required under section 510 of the FD&C Act, which is prohibited under section 301(p), 21 U.S.C 360 and 331(p). In addition, your firm, The Body Bean, LLC, failed to fulfill its listing obligations under section 510(j) of the FD&C Act, which is a prohibited act under section 301(p), 21 U.S.C. 360(j) and 331(p). Failure to properly list a drug with FDA also renders it misbranded under section 502(o) of the FD&C Act, and in violation of section 301(a) of the FD&C Act, 21 U.S.C. 352(o) and 331(a). As a result, the drug, The Body Bean’s Hand Sanitizer - Scented, is misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o).
Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.
We note that this warning letter only addresses registration and listing issues associated with your products. It is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to firstname.lastname@example.org. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at email@example.com for further assistance. Include the case identification numbers 2474 on all correspondence.
Director (Acting), Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
CC: Los Angeles District Office
Attn: Steven E. Porter, Jr.