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WARNING LETTER

Proprietary Wellness LLC MARCS-CMS 482248 —


Recipient:
Proprietary Wellness LLC


United States

Issuing Office:
Cincinnati District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Cincinnati District
Central Region
6751 Steger Drive
Cincinnati, OH 45237
Telephone:    513-679-2700
FAX:               513-679-2772

 

September 27, 2016
 
WARNING LETTER
CIN-16-482248-23
 
Via United Parcel Service
 
Eric D. Marchewitz, Owner
Proprietary Wellness, L.L.C.
34736 S. Gratiot Avenue
Clinton Township, MI 48035
 
Dear Mr. Marchewitz:                                          
                                                                                               
This is to advise you that your firms’ marketing and distribution of the products “pBOLD” and “1-ANDRO” violates the Federal Food, Drug, and Cosmetic Act (the Act). 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. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
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. Specifically:
 
1.    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.  The product labeling for your 1-Andro product declares 3b-hydroxy-androst-1-ene-17-one as a dietary ingredient, and the product labeling for your pBold product declares 17beta-[1-ketoethyl]-androsta-1,4-diene-3-one,17a-ol as a dietary ingredient. Under section 201(ff)(1) of the Act [21 U.S.C. § 321 (ff)(1)], a dietary ingredient is a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. 3b-hydroxy-androst-1-ene-17-one and 17beta-[1-ketoethyl]-androsta-1,4-diene-3-one,17a-ol are not vitamins, minerals, herbs or other botanicals, or amino acids. In addition, neither 3b-hydroxy-androst-1-ene-17-one nor 17beta-[1-ketoethyl]-androsta-1,4-diene-3-one,17a-ol are dietary substances for use by man to supplement the diet by increasing the total dietary intake. Finally, 3b-hydroxy-androst-1-ene-17-one and 17beta-[1-ketoethyl]-androsta-1,4-diene-3-one,17a-ol are not concentrates, metabolites, constituents, extracts, or combination of vitamins; minerals; herbs or other botanicals; amino acids; or dietary substances for use by man to supplement the diet by increasing the total dietary intake. Accordingly, 3b-hydroxy-androst-1-ene-17-one and 17beta-[1-ketoethyl]-androsta-1,4-diene-3-one,17a-ol are not a dietary ingredients within the definition set forth in section 201(ff)(1) of the Act. 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. The terms "serving" or "serving size" for a dietary supplement are defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2, as the maximum amount recommended on the label for consumption per eating occasion. For example, the directions of use for your 1-Andro and pBold products suggest the consumer take “2-4 tablets per day in divided doses,” but the serving size lists “1 tablet.” The serving size should be four tablets.
 
3.    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. Specifically, the statement of the place of business fails to include the zip code in accordance with 21 CFR 101.5(d).
 
4.    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. Each label lists “phytosterols,” but fails to list the names of the individual phytosterols. 
 
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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
  
You should take prompt action to correct the violations cited in this letter and to prevent their recurrence. Failure to do so may result in enforcement action without further notice, including, without limitation, seizure and injunction. 
 
In addition to the above violations, we have the following comments:
 
Regarding both pBold and 1-Andro products:
  • The “D.V. not established” footnote should appear immediately below the Supplement Facts listing of dietary ingredients and before the ingredients statement.
  • The Supplement Facts label includes the statement, “Men over 21 only.” This intervening material is not permitted within the Supplement Facts label, in accordance with 21 CFR 101.2(e).
  • If phytosterol or phosphatidylcholine is functioning as a dietary ingredient, it should be listed in the Supplement Facts label. 
Within fifteen working days of the receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the cited 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed.  Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237, Attention: Mark E. Parmon, Compliance Officer. You may reach Mark Parmon by phone at (513) 679-2700, Ext. 2162, or email at mark.parmon@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Steven B. Barber
District Director
Cincinnati District