Hypoallergenic cosmetics are products that manufacturers claim produce fewer allergic reactions than other cosmetic products. Consumers with hypersensitive skin, and even those with "normal" skin, may be led to believe that these products will be gentler to their skin than non-hypoallergenic cosmetics.

According to FDA, there are no Federal standards or definitions that govern the use of the term ?hypoallergenic?. The term means whatever a particular company wants it to mean. Manufacturers of cosmetics labeled as hypoallergenic are not required to submit substantiation of their hypoallergenicity claims to FDA. A Federal court has struck down an FDA regulation requiring cosmetic manufacturers to conduct tests to back up any claim that a product is "hypoallergenic."

For many years, companies have been producing products which they claim are "hypoallergenic" or "safe for sensitive skin" or "allergy tested." These statements imply that the products making the claims are less likely to cause allergic reactions than competing products. But there has been no assurance to consumers that this actually was the case.

For the past four years, the Food and Drug Administration has been working to clear up this confusion of claims by establishing testing requirements that would determine which products really are "hypoallergenic." The manufacturers of cosmetic products claiming to be "hypoallergenic" were to be responsible for carrying out the required tests.

Numerous comments on the proposal were received from consumers, consumer groups and cosmetic manufacturers. Some people urged a ban on the use of the term "hypoallergenic" on grounds that most consumers don't have allergies. Others suggested that the term be banned because allergic individuals cannot use "hypoallergenic" products with any assurance of safety. A number of cosmetic manufacturers complained about the requirement for product comparison tests to validate claims of hypoallergenicity. Among other things, they said the tests would pose an undue economic burden on them.

In responding to the comments, FDA pointed out that the proposed regulation was not intended to solve all problems concerning cosmetic safety. The primary purpose of the regulation, the Agency said, was to clear up confusion about the term "hypoallergenic" and to establish a definition that could be used uniformly by manufacturers and understood by consumers.

FDA issued its final regulation on "hypoallergenic" cosmetics on June 6, 1975. Although the final regulation did require comparative tests, procedures for carrying out the tests were changed to reduce the costs to the manufacturers.

The new regulation was quickly challenged in the U.S. District Court for the District of Columbia by Almay and Clinique, makers of "hypoallergenic" cosmetics. The two firms charged that FDA had no authority to issue the regulation, but the court upheld FDA.

The firms then appealed to the U.S. Court of Appeals for the District of Columbia, which ruled that the regulation was invalid. The appeals court held that FDA's definition of the term "hypoallergenic" was unreasonable because the Agency had not demonstrated that consumers perceive the term "hypoallergenic" in the way described in the regulation.

As a result of the decision, manufacturers may continue to label and advertise their cosmetics as "hypoallergenic" or make similar claims without any supporting evidence. Consumers will have no assurance that such claims are valid unless proper tests were conducted.

There are two clinical-pharmacological tests used to evaluate safety of products for topical application. They are Patch Test and Repeated Insult Patch Test. The Patch Test usually lasts 48 hours. The cellular turnover of the skin lasts 28 days. This means that products tested only for 2 days cannot be called hypoallergenic, because two days are not enough to really test the product. The Repeated Insult Patch Test lasts for 30 days, that is to say, two more days of the skin cellular turnover. This is why the product that managed to over come such a rigid test is certified as ?Incapable of causing irritation or allergic reactions?.

VB products have overcome the strictest clinical-pharmacological test in the University Laboratories for Maximum Safety in use: ?The Repeated Insult Patch Test?. All Villa Borghini products are certified as incapable of causing irritation or allergic reactions.

Up to today, VB is the unique whole range of products in the world that was able to overcome the hardest test for maximum safety in use.