Inspections, Compliance, Enforcement, and Criminal Investigations
Before and After Cosmetic LLC 06-Oct-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
| Central Region |
New Jersey District
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 526-6005
RETURN RECEIPT REQUESTED
Mr. Keith Traub
Mr. Avrum Catz
Before and After Cosmetics LLC
233 West Parkway
Pompton Plains, NJ 07444
Dear Messrs. Traub and Catz:
This letter is in reference to your firm's marketing and distribution of "MenoCream," a topical hormone cream. A review of your website on September 14, 2005, and an inspection by an investigator from this office conducted February 14-15, 2005, documented that you market this product for the relief of menopausal and premenopausal symptoms. The labeling for this product contains claims that cause the product to be a drug, as defined by section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(C). Labeling is not limited to the product container, but also includes promotional statements on your website, www.beforeandaftercosmetics.com, where MenoCream is offered for sale.
Following are examples of labeling claims for this product that establish its intended use as a drug:
"Before & After MenoCream™ . . . For Menopausal Relief'. . .
"Relieves Menopausal and Pre-Menopausal Symptoms Including: Hot Flashes, Night Sweats, Menopausal Caused Sleeplessness, Vaginal Dryness, Mood Swings, Water Retention, Decreased Libido"
"Before & After MenoCream™ . . . Safely Relieves Menopausal and Pre-Menopausal Symptoms!"
"At Last! . . . A Safe, Effective Alternative to Synthetic Prescriptions!"
"Safe, Natural Relief For: Hot Flashes, Night Sweats, Menopausal Cause [sic]
Sleeplessness, Vaginal Dryness, Mood Swings, Water Retention, Decreased Libido"
These claims indicate that MenoCream is intended to affect the structure or function of the body. Accordingly, MenoCream is a drug under section 201(g)(1)(C) of the Act, 21 U.S.C. § 321(g) . Moreover, because MenoCream is not generally recognized as safe and effective for these claimed indications, MenoCream is a new drug as defined by section 201(p) of the Act, 21 U.S.C. § 321(p).
Under section 505(a) of the Act, 21 U.S.C. § 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Section 301(d) of the Act, 21 U.S.C. § 331(d), prohibits the introduction or delivery for introduction into interstate commerce of any article that violates section 50:5. Because there is no FDA-approved application for MenoCream, your distribution of this product in interstate commerce violates sections 505(a) and 301(d) of the Act.
Menocream is also misbranded under section 502(e) of the Act, 21 U.S.C. § 352(e), in that its labeling fails to differentiate between its active ingredient, natural progesterone, and its inactive ingredients. Nor does the product properly list these inactive ingredients in alphabetical order. The product is further misbranded under section 502(c) of the Act, 21 U.S .C. § 352(c) because it does not follow the drug labeling format requirements under 21 CFR § 201 .66.
This letter is not intended to be an all-inclusive review of the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
We request that you take prompt action to correct the noted violations . Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. In addition, federal agencies are advised of the issuance of Warning Letters pertaining to drugs so that they can consider this information when awarding contracts.
Please notify this office in writing within fifteen working days of receipt of this letter of the specific steps that you have taken to correct the noted violations, including an explanation of steps taken to prevent the recurrence of similar violations . If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your reply should be directed to the attention of Joseph F. McGinnis, R.Ph, Compliance Officer, Food and Drug Administration, at the attached letterhead address.
Ray Abrahams for Douglas I. Ellsworth
New Jersey District