What happened
Original notice title
Proprietary Wellness LLC 9/27/16
From the archived source record
Based on our review of your products’ labeling, we found serious violations of section 403 of the Act [21 U.S.C. § 343] and the regulations implementing the food labeling requirements of the Act found in 21 CFR part 101. Misbranded Dietary Supplements Your pBold and 1-Andro products are misbranded dietary supplement under section 403 of the Act [21 U.S.C. § 343] because the products do not comply with the labeling requirements for dietary supplements. Your pBold and 1-Andro products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading. Declaring these ingredients in your product labeling as dietary ingredients causes your products marketed as dietary supplements to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular. 2. Your pBold and 1-Andro products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the serving size declared on the labels are incorrect. Your pBold and 1-Andro products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to list the name and place of business of the manufacturer, packer, or distributor. Your pBold and 1-Andro products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 20856326c928
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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