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| 1. There are no standards for hypoallergenic 2. There are no standards for hypoallergenic 3. The producer or manufacturer decides whether to use the claim and is not free from its own self-interest. |
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LABEL CATEGORY:
General Claims
WHAT THIS GENERAL CLAIM MEANS:
There is no government or official definition for this term.
WHO VERIFIES THIS GENERAL CLAIM?
There is no organization behind this claim other than the company manufacturing or marketing the product.
CONSUMERS UNION EVALUATION:
How meaningful is the label?
The hypoallergenic label is not meaningful. Hypoallergenic is a general claim that implies a product will be less likely to cause allergic reactions.
However, the Food and Drug Administration (FDA) states that “There are no federal standards or definitions that govern the use of the term ‘hypoallergenic’.” In 1974, the FDA tried to establish definitions for the use of the term hypoallergenic, but the regulation was overturned in court. Manufacturers of cosmetics labeled as hypoallergenic are not required to submit substantiation of their hypoallergenicity claims to FDA.
The FDA “does not know of any scientific studies done to see if ‘hypoallergenic’ products produce fewer allergic reactions than products that don’t have the claim.” The same is true for the terms “dermatologist-tested,” “sensitivity tested,” “allergy tested” and “nonirritating.” They also state that there is no such thing as a “nonallergenic” cosmetic and that almost all cosmetics can cause allergic reactions in certain individuals.
According to the American Academy of Dermatology (AAD), fragrance is the number one cause of allergic reactions in cosmetics. There are over 5000 basic fragrances used in various cosmetic products including perfumes, colognes, skin care products, soaps, shampoos, lipsticks, sunscreens, and lotions. Products labeled as “unscented” can also contain fragrances that are used to cover up the chemical smell of the other ingredients in the product. Preservatives are another example of a common trigger for allergic reactions in cosmetics products.
Foods, drugs, and cosmetics are required to list their ingredients (with a few exceptions, such as fragrances in cosmetics), but household cleaning products are not required to disclose their ingredients (except for disinfectants or other ingredients considered to be antimicrobial pesticides).
Since manufacturers are allowed to consider fragrances as trade secrets, they are not required to list specific fragrance ingredients on the product. As a result, consumers may not be able to identify the specific cause of an allergic reaction from a cosmetic product.
Is the label verified?
No, the FDA has not defined the term. Under the regulatory authority given by the Federal Food, Drug and Cosmetics (FD&C;) Act, the FDA can only take action on products it deems “misbranded” (misleading to consumers) or adulterated (contaminated and potentially unsafe) after such products have already been marketed. However, without any formal definition of “hypoallergenic” it would be difficult for the FDA to take action against manufactures making such claims.
Is the meaning of the label consistent?
No, the label can have different meanings for different products.
Are the label standards publicly available?
No, there are no standards for the use of this label.
Is information about the organization publicly available?
No, there is no organization that has established standards for this label.
Is the organization free from conflict of interest?
No. There is no organization independently certifying this claim. The producer or manufacturer decides whether to use the claim and is not free from its own self-interest.
Was the label developed with broad public and industry input?
Yes, when FDA proposed its regulations for “hypoallergenic” in 1974, they received numerous comments from the public and industry on the issue. Almay and Clinique, two cosmetic manufacturers of “hypoallergenic cosmetics,” challenged the FDA and initially lost. However, they appealed the case and eventually the court overturned the regulation on the grounds that cosmetic and toiletry products would not be able to prove that their products caused fewer allergies and said that FDA should ban the use of the term. Consumers Union, host of eco-labels.org, also submitted public comment at that time urging the FDA to ban the use of the term.