Looking to promote the safety of your product? Tout the fact that your children’s bath and shampoo products do not contain formaldehyde. In a recent test, the Campaign for Safe Cosmetics found 23 children’s bath products that that may cause cancer and skin allergies. Another product, 1,4-dioxane, was found in 32 of 48 products. The EPA considers 1,4-dioxane a probable human carcinogen. National media including USA Today and The Washington Post picked up on the report and giant consumer companies such as Johnson & Johnson had to turn up their PR machines to counter the negative press.

A number of environmental and health groups including the Breast Cancer Fund and the Environmental Working Group, are behind the Campaign for Safe Cosmetics. They hired Analytical Sciences to perform the tests. The California lab found formaldehyde and 1,4-dioxane in a wide variety of products. Among the brand names were Baby Magic, L’Oreal and  Aveeno.

A number of companies that operate in the organic sphere are already wise to the potential health threats. USA Today reported that Earth Friendly Products, Life Tree, Nature’s Gate, Planet Ultra and Seventh Generation have all reduced levels of 1,4-dioxane since the previous Campaign report. A representative for Whole Foods told the paper that it was reformulating its 365 Everyday Value products to be free of 1,4-dioxane by July.

The European Union has banned 1,4-dioxane as an ingredient in personal care products, the Post reported, and Congress may direct the FDA to take action. “The fact that we are bathing our kids in products contaminated with carcinogens shows how woefully out of date our cosmetics laws are and how urgently they need to be updated,” said Rep. Jan Schakowsky of Illinois told the Post. “The science has moved forward; now the FDA needs to catch up and be given the authority to protect the health of Americans.”

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carminic acid

This final rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract-containing food and carmine-containing food and cosmetics and will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives.  This action also responds to a citizen petition submitted by the Center for Science in the Public Interest (CSPI).

To read the Federal Register notice, click here.

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As you might imagine, the use of the term “organic” on a product containing agricultural ingredients can be very valuable. Many people search out organic products and are willing to pay a premium for them. As a result, products labeled “organic” can command higher prices and produce greater profits. The OFPA was passed, and the NOP regulations were created, in order to make sure that products labeled organic were really what they claimed to be.

During the rulemaking process for the NOP regulations, some companies that made cosmeceutical and other body care products with organic agricultural ingredients requested that they be allowed to use the organic certification on their products just like with traditional food products. This made sense because, other than the fact that these products are not “ingested” in the traditional way foods are, they were made with agricultural ingredients meeting the same organic standards as foods.

On May 2, 2002, the USDA issued a “policy statement” that allowed producers of any organic agricultural product, regardless of its end use, to seek organic certification. This opened up the organic certified products market to a variety of body care product manufacturers. Manufacturers embraced this new opportunity and began to produce a wide variety of products made from agricultural ingredients that obtained organic certification like soaps, crèmes, lotions and other cosmeceuticals.

Then, for no apparent reason, almost two years later, the USDA did a 180 degree turn and reversed itself by issuing a “guidance statement” that stated that because the OFPA did not cover “non-agricultural products,” makers of personal care, body care and cosmetic products could not obtain NOP organic certification.

The USDA’s about-face made no sense. As the Organic Consumers Association (OCA) stated in its complaint against the USDA seeking to invalidate the “guidance statement,”

“certified organic olive oil does not magically become “non-agricultural” when used as an ingredient in a massage oil rather than as an ingredient in a salad dressing.”

The OCA and a leading organic body products maker sued. On August 23, 2005, the eve of the deadline for its response to the complaint, the USDA backed down and issued a memo to organic certifiers that certified non-food products specifically including personal care may represent that they are NOP certified “organic” or “made with organic,” and display the USDA organic seal, so long as such products are certified to meet the NOP standards for organic agricultural products.

So the OCA was able to get the USDA to back down from its decision to restrict the OFPA’s coverage to food products. But why did the USDA insist on taking this position in the first place? As I have learned while researching the various agency positions effecting producers of natural products and nutritional supplements, the government is often just plain wrong with significant consequences to the industry and consuming public. I am not going to opine broadly on why this is the case. However, it does appear that all too often the government fails or refuses to follow the law unless it is forced too. Examples from the FDA, FTC, and others abound and are sure to be a topic of conversation on this blog….stay tuned.

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