Skipping the regulatory review of a new product to determine whether its FDA regulated comes with consequences as the FDA demonstrated when it issues a recall notice today. The recall notice was for an unapproved product which it deemed a “new drug.”
January 19, 2012 -Perfect Image Solutions, LLC is voluntarily recalling all lots of Men’s Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL; Men’s Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL; Men’s Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL; Women’s Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL; and Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL, to the consumer level. The products are deemed “unapproved new drugs” under the law and U.S. Food and Drug Administration regulations and may present potential health hazards. (emphasis added).
Under Section 201(g)(1) (B) of the Food Drug and Cosmetic Act [21 U.S.C. 321(g)(1)(B)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man are drugs. The claims made on product labels and in their labeling is one way to establish that a product is a drugs under the statutory definition.
The same can be said for a medical device.
Even if a product is not a drug, but is instead a dietary supplement (a/k/a nutriceutical) it is still subject to FDA regulations. For example, it could be recalled because it is misbranded (section 403(i)(2): of the Act [21 U.S.C. § 343(i)(2)J,]).
Although you may be eager to get to market and begin selling your new product, it is important to consult the regulations to ensure it is not a regulted medical device or drug. Even if the regulations wouldn’t consider the product a drug or device the label and marketing must be carefully created not to make any drug or device claims. The FDA, as seen in this example, will recall any and all product sold when it decides an unapproved product has been marketed and sold. The FDA can also impose other fines and sanctions. This is a major loss for the company and irreversaibly damaging for the brand.
Putting a little time and money in now can save a company in the long-run.
|Product Name||Lots||Expiration||UPC Number|
|Men’s Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL.||All||Up until Oct. 2013||736211275813|
|Men’s Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL.||All||Up until Oct. 2013||736211276018|
|Men’s Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL.||All||Up until Sept. 2014||736211276117|
|Women’s Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL.||All||Up until Nov. 2013||736211274519|
|Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL.||All||Up until Dec. 2013||736211276414|
Leave a comment