FDA
In a move aimed at ensuring the safety of consumer products that contain ultra-tiny super-materials, the U.S. Food and Drug Administration has released tentative guidelines to help manufacturers of food ingredients and cosmetics stay in line with the law.
The proposed guidelines are the continuation of a shift toward scrutinizing ultra-tiny versions of well-known materials as potentially different from their larger counterparts.
With the agonizing gaps in understanding about nanotechnology and the materials it has spawned, the agency is still saying that it’s basically up to companies to monitor the safety of their products.
But, these new guidelines say, it’s not enough to rely on the existing knowledge about a chemical or substance that’s been cleared in its larger state. A version of that material that’s on the nanoscale (a nanometer is a billionth of a meter) may require additional testing and approvals — even if it’s already on the market.
Advocates for both manufacturers and consumers greeted the FDA’s latest guidelines with interest; after all, there has been little movement at the regulatory level where nanotechnology is involved. A lawyer who works with manufacturers called the guidelines “useful.” A consumer advocate found them “pitiful.”
The U.S. Environmental Protection Agency has already moved toward treating certain materials, such as nanosilver, differently than their bigger cousins. The FDA seems to now be making a similar move — without formally defining “nanomaterial,” in keeping with the rest of the federal government.
Nanotechnology makes use of the often-unique properties of super-small particles to create products with amazing qualities. These materials can make better batteries or lighter and stronger bike frames, as well as new medical instruments and medicines that can save lives. They’re increasingly common in consumer products, from “mineral-based” sunscreens to stain-repellent pants to boat paints that resist algae growth.
Nanomaterials are believed to hold great promise for a wide variety of applications. Their ultra-tiny size also gives them different properties; scientists are struggling to figure out whether that can make them dangerous in the process, and how and why it happens.
But there are big hurdles to that effort — namely, testing methods that are only now beginning to catch up with the demands of looking at nanoparticles and what they can do.
The FDA’s latest missive builds on a series of documents released last summer that outline broader federal policy on dealing with nanotechnology and nano-enabled products. These new guidelines — which are basically for informational purposes, and not binding regulations — don’t address drugs or medical devices, an area where nanotechnology appears primed for a boom.
However, food (including additives and packaging) and cosmetics are also ripe for nano-based applications. Nanosilver is already being used to fight bacteria in plastic food-storage containers; scientists are building all kinds of wraps and packaging to extend shelf life. Face creams packed with gold nanoparticles are routinely sold to fight wrinkles.
The FDA wants to know what’s in those products, and how the nano-sized ingredients might be different from other uses that the agency has already signed off on, said Dennis Keefe, the director of the food additive safety office at the FDA.
“We want to have a dialogue with industry,” he said, whether it’s about existing products or new manufacturing changes that might create what’s effectively a different product from a regulatory perspective.
“We want to make the manufacturers aware that they still have a responsibility here,” Keefe said.
A major change involves categorizing ingredients or additives as “generally regarded as safe,” or GRAS in agency parlance. This is essentially a fast track for substances that have been independently studied and proven to be safe; the FDA then routinely allows their use.
For now, at least, that label won’t be applied to nanoscale additives, according to the new guidelines, Keefe said.
“At this point, I don’t think it’s likely that the science would support a generally recognized as safe status for these ingredients,” Keefe said.
That’s one of the reasons the FDA wants companies to come in and talk, he said.
“It’s a relatively new technology, and there’s differing scientific views on this, and it’s evolving. We can’t prevent somebody from making an independent determination, but we’re signaling that it’s unlikely that you could make a GRAS determination,” Keefe said. “That doesn’t mean that you couldn’t come in and talk to us and convince us.”
The Reaction
Lynn Bergeson, a lawyer at the Washington firm Bergeson & Campbell who works with nanotechnology companies on navigating the regulatory process, said the FDA’s release embodies the government’s general position that it wants to regulate products, not technologies, and that where nano in concerned, guidelines and regulations should be “iterative, adaptive and flexible.”
Informal discussion has become a key part of the process, too.
“That has been a consistent refrain between and among federal agencies in general: ‘when in doubt, come in and talk,’‘’ Bergeson said.
While she doesn’t see much new in the documents, Bergeson said the specificity about, for example, what constitutes a “significant change” in a manufacturing process will be useful to manufacturers. One of those changes is morphing particle size, which is how macroscale materials become nanoscale.
“I found that very helpful because heretofore, that has not been stated with any degree of particularity or granularity,” she said.
Bergeson also praised the FDA’s specificity involving how to characterize particle size and other elements in terms of cosmetics ingredients. While the FDA has far less regulatory power over cosmetics — there’s no premarket review, and the burden is entirely on manufacturers to policy safety issues — it’s still useful for companies to have the boundaries laid out for them, she said.
“They’re on notice that this is what the government is looking at,” she said. “I think it just provides better clarity.”
Jaydee Hanson, policy director at the International Center for Technology Assessment, called the FDA’s moves “pitiful.” Hanson’s organization, a non-profit group that studies the impact of a wide variety of technologies, sued the FDA late last year to compel the agency to respond to a 2006 petition asking for specific regulations for nano-enabled products.
A federal judge told the FDA to respond by April 23, Hanson said. The organization got its response on April 20 — the same day the “draft guidance” documents on food and cosmetics were issued.
“It’s amazing that they couldn’t have issued these new guidelines two weeks after we filed our legal petition,” Hanson said. “What they’ve come up with is not anything more than baby steps beyond what they had before … it’s not bad, but there really isn’t anything in here that’s new.”
Keefe said the judge’s due date had nothing to do with the release of the guidelines, which he said had been in the works for several years. There’s a 90-day comment period to solicit feedback from the public as well as advocates on both sides. It’s unclear when final versions of the guidelines might be released, although it’s likely to be a while — the draft documents issued last June have yet to be issued in final form.
Hanson said it’s possible that by “asking nicely,” the FDA will glean important informatoin from manufacturers about what’s in food, food additives and packaging, and cosmetics. But the agency isn’t significantly addressing labeling, which would allow consumers to identify products that use super-small materials to boost their efficacy.
“Labeling’s not a cure-all, but at least you can start tracking what’s going on with stuff,” Hanson said.
Sunscreens Not Covered
One example of opaque labeling involves sunscreens, which are regulated by the FDA as drugs, not cosmetics — and therefore not covered by this latest missive. Physical sunscreens that use super-small titanium dioxide or zinc oxide aren’t labeled as containing nanoparticles, making it difficult to suss out what’s inside without knowing the background (one hint: if it goes on clear, it’s nano!).
Face creams and lotions, which are covered by the draft guidelines, often don’t carry a “nano” label, either. The FDA’s new guidelines on cosmetics say “they must be safe for consumers under labeled or customary conditions use, and they must be properly labeled.” It’s unclear whether that means labeling active ingredients, or including the particle size on the list.
Keefe said the agency expects the discussion with industry and advocates to begin now, with the comment period open (you can comment on the drafts here). If these guidelines are general in places, it’s because the FDA doesn’t want to specify a test or other assessment for a particular area, only to encounter pushback from a manufacturer when the agency wants more information.
“We don’t want to tie our hands,” he said.
As for the somewhat voluntary nature of the open-door invitation, Keefe said, the pressures of the market should help push companies to start talking. A food additive maker, for example, is developing a product to sell to another company — which wants to know about safety and exactly what’s on the ingredients list. That should push manufacturers to be transparent, he said.
If someone wants to break the law, they will, he added. The FDA is betting that most companies don’t.
“I think for the most part, the companies are going to see it’s in their best interest to play right, to follow the rules,” Keefe said.
