Does the FDA have authority to ensure your baby’s bubble bath is free from carcinogenic ingredients like formaldehyde? If FDA found harmful levels of such ingredients in a product, could it enforce a recall? In 2012, if a company decided to include arsenic in face cream, would it have to notify the FDA first?
Rep. Ed Markey (D-MA) who introduced the Safe Cosmetics Act to Congress last year, fired off these questions during Tuesday’s Congressional cosmetics hearing, the first in more than 30 years, knowing the answer—no to all of the above—defies reasonable expectations of cosmetics industry safety.
Under the Food, Drug and Cosmetic Act established in 1938, the FDA doesn’t require premarket safety testing or full ingredient disclosure on labels. And if potentially dangerous levels of toxic ingredients do end up in products (which does happen: consider recent news about dangerous levels of formaldehyde in Brazilian Blowout products or mercury levels linked to mercury poisoning in skin-lightening creams), the FDA also can’t enforce recalls.
But this could all (or at least some of it) change soon.
The debate over tighter legislation
Last month, the Campaign for Safe Cosmetics put pressure on the House Energy and Commerce Committee with a letter [PDF] signed by 100 environmental groups and businesses, including natural personal care companies California Baby, Weleda, and WS Badger Company.
“This is a critical time for the future of cosmetic safety in the United States. Industry, environmental groups and both parties seem to agree that the failed 1938 cosmetics laws need to be updated, but the million-dollar question is, will it be meaningful reform or will industry write its own rules and make a bad situation worse?” said Janet Nudelman, policy director of the Breast Cancer Fund, in a press release from the Campaign for Safe Cosmetics.
During the March 27 hearing, cosmetic-, health- and environmental-industry representatives discussed how the proposed changes would impact suppliers and manufacturers in the mass and natural cosmetics markets.
Like many in the natural personal care industry, Debbie May, CEO of soap ingredient supplier Wholesale Suppliesplus, supports increased FDA authority such as enforcing recalls and ingredient testing and disclosure. But during the hearing, she also pointed out aspects of updated legislation that could have negative effects on small, independent manufacturers.
“We personally inspect each ingredient and have our hands in every part of the manufacturing process. We do not support reporting to FDA individual ingredients because we frequently buy small quantities of ingredients several times a week,” she said. “We want to make sure small businesses have the same opportunities to grow.”
She also said that if regulations vary from state to state there could be confusion and additional barriers for small businesses.
Mass vs. natural beauty companies
Conventional brands and some small businesses have raised concerns about how stricter legislation regarding ingredients could impact innovation, with the risk of current chemical levels in cosmetics shaping up to be the main source of debate between mass and natural companies.
Halyna Breslawec, PhD, chief scientist and executive vice president for science of the Personal Care Products Council—a cosmetics trade association representing 600 brands including Elizabeth Arden and L’Oreal—said “simple but important” changes are necessary to bring legislation up to date. But when it comes to safety, she said the cosmetics industry performs its due diligence, putting $3.6 billion into research and development to ensure safety of the 2,000 new products each year.
But are any chemical levels acceptable in cosmetics?
Michael J. DiBartolomeis, PhD, who heads up the California Safe Cosmetics Program that implements many cosmetics regulations not currently enforced under the FDA—testified that companies have reported to his office (mandatory under the California Safe Cosmetics Act of 2005) 17,060 personal care products that contain at least one of 96 carcinogens or reproductive toxicants. He concluded the hearing by saying that science or voluntary testing won’t necessarily ensure cosmetics are safe for long-term use when you're dealing with these ingredients.
“For most products that contain chemical carcinogens, the dose and risk are difficult things to analyze. Carcinogens should really not be in these products at all, especially when they’re being used from infancy all the way through the lifespan.”
3 ways to build a trusted natural beauty brand
As Congress deliberates these issues, here’s how to develop a trusted natural beauty brand—and be prepared for regulatory changes.
1. Strengthen relationships with reliable suppliers
Even if sourcing natural ingredients, to ensure quality it’s critical to work closely with suppliers and to choose suppliers that conduct safety testing for each ingredient.
“With drugs, you have to have a paper trail. Every material has to be tested coming in. The finished product has to be tested—there’s lots and lots of testing,” said Jessica Iclisoy, founder of California Baby.
Operating a single facility as both a drug facility for products (such as sunscreen and diaper rash balm) and a certified organic cosmetics facility for other bath and body products, California Baby has created an exemplary manufacturing model that places an equal level of scrutiny on each product’s ingredients.
“We don’t distinguish as a brand between our drugs and our cosmetics. We make our bubble bath the same way that we make our diaper rash cream. We’re dealing with suppliers that have to supply us with ingredients that meet a certain level of purity and they have to prove it," said Iclisoy.
While ingredient testing isn’t yet required for cosmetics, more and more suppliers are enforcing these practices because that’s what natural brands demand, said Larry Weiss, MD, founder of CleanWell, a manufacturer of all-natural antibacterial liquid hand sanitizers and soaps. “We have seen all sorts of raw material suppliers grow the expertise internally. It is so interesting that we’re the one holding these folks accountable.”
Regardless of whether updated legislation requires testing, choosing responsible suppliers means your brand will have this safety information available to establish a deeper level of trust and loyalty from consumers and retailers.
And when it comes to herbs and botanicals, sourcing directly from local farmers and conducting extractions in house is the ultimate way to ensure purity.
2. Get independent testing on finished products
Working with responsible suppliers is just part of the solution. Independent, finished-product tests can give your brand the competitive edge (and a safety blanket) over discerning consumers and new research revealing questionable ingredients in products—including natural ones.
When a recent FDA report uncovered lead in more than 400 lipsticks, testing quickly became key to the conversation. In addition to working with trusted suppliers who test ingredients, Mineral Fusion sends out products for third-party testing, said Tim Schaeffer, senior vice president of marketing. Burt’s Bees, a brand found to contain levels of lead in the new report, plans to start conducting similar finished-product tests to restore confidence in the brand’s safety.
When a new study from Silent Spring Institute targeted natural brands, including California Baby, for containing certain questionable ingredients, Iclisoy—who in the past had relied exclusively on supplier testing—sent her products out for independent tests only to find the results for the ingredients in question were zero (Silent Spring later revealed samples were from 2008).
“Now we’re putting a process in place that we’re going to test every quarter a different batch for a set group of chemicals and post on our web site to show that we’re free of these things,” she said. “That’s what’s going to separate the companies that are strong and are the leaders.”
Because this can be costly and resource intensive, manufacturers need not to test every batch or product.
Beyond safety, if making results claims, you also should have research to support your product’s performance—and that’s what educated and engaged consumers are looking for, according to a recent report from market research firm the Kline Group. In addition to ingredient testing, finished-product testing will help your brand stand out in naturals and compete with mass.
3. Disclose every ingredient—including fragrance
Under current legislation, companies aren’t required to list constituent ingredients of fragrances, colorants or salon beauty products on labels.
The main ingredient that remains an issue in the natural products industry is fragrance—though most brands are using natural blends, many are still not dislosing its constituents. Whether because of allergies (even to some natural ingredients) or potential health risks of synthetics, consumers have become increasingly skeptical of “fragrance” on an ingredient list.
It may appear more cumbersome on a label, or require additional testing, but consumers will appreciate the transparency that comes with fully disclosing every ingredient, even those that make up natural fragrances. Plus, the government may soon require it.
For more information on companies that have agreed to full ingredient disclosure, see Compact for Safe Cosmetics: 321 companies changing the beauty industry.