THE United States Food and Drug Administration (FDA) has detained parts of two shipments of soaps exported from Jamaica by the Blue Power Group.
The FDA, which is responsible for protecting America’s public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products, cosmetics and food etc, detained the shipments for review in relation to compliance with regulations.
The shipments were being sent to Blue Power’s American distributor, Iberia Foods, which is a leading food and beverage distributor within America’s Hispanic and Caribbean markets. The Jamaica Observer has been reliably informed that the detention of the shipment was due to the FDA having concerns about aspects of the labelling, describing the product as a soap rather than a cosmetic. When contacted, Blue Power Chairman Dr Dhiru Tanna confirmed the detention.
He told the Business Observer “Two partial shipments of our soaps were held back by the FDA in the United States mainly because of labelling requirements, and that this matter is now being dealt with mainly by our attorneys in the United States. We expect that the matter will be resolved very soon and we will be free to ship our products to the United States very soon.
“At the moment there is no hold on our laundry soap, which is being shipped without any problem whatsoever,” Tanna said.
Blue Power is, however, emphasising that its “relationship with Iberia Foods in the United States continues to be good”.
If a product meets the regulatory definition of soap, it is regulated by the US Consumer Product Safety Commission and not by FDA. However, if it is a cosmetic, then it is regulated by FDA.
Cosmetics marketed in the United States, whether manufactured there or imported, must be in compliance with the provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act), Fair Packaging and Labeling Act External Link Disclaimer, and the regulations published under the authority of these laws. The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions.
However, soap products consisting primarily of an alkali salt of fatty acid and making no label claim other than cleansing of the human body are not considered cosmetics under the law. To meet the definition of soap in FDA’s regulations, a product has to meet three conditions:
1. What it’s made of: To be regulated as “soap” the product must be composed mainly of the “alkali salts of fatty acids” — that is, the material you get when you combine fats or oils with an alkali, such as lye.
2. What ingredients cause its cleaning action: To be regulated as soap, those alkali salts of fatty acids must be the only materials that result in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap. You still can use the word soap on the label.
3. How it’s intended to be used: To be regulated as soap, it must be labelled and marketed only for use as soap. If it is intended for purposes such as moisturising the skin, making the user smell nice, or deodorising the user’s body, it’s a cosmetic. Or, if the product is intended to treat or prevent disease, such as by killing germs, or treating skin conditions such as acne or eczema, it’s a drug. You still can use the word soap on the label.