Evolved Ayurvedic Discoveries, Inc./BioCBDPlus
3 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
The claims on your website and social media websites establish that your BioCBD+ products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Products are unapproved new drugs due to disease treatment claims.
Supporting FDA text
Source excerpt · automated text-match checkThe claims on your website and social media websites establish that your BioCBD+ products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).
Products are misbranded because labeling lacks adequate directions for use.
Supporting FDA text
Source excerpt · automated text-match checkYour BioCBD+ products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use.
Total Body Care is not a dietary supplement because CBD is excluded from the definition.
Supporting FDA text
Source excerpt · automated text-match checkYour “BioCBD+ Total Body Care” product is labeled as a dietary supplement. However, it cannot be a dietary supplement because it does not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff).
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide specific steps taken to address the violations
- Provide explanation of each step being taken to prevent recurrence of violations
- Provide copies of related documentation
- If products are believed not in violation, provide reasoning and supporting information
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.