Everyone has an Opinion on Unique Device Identification 1

By Mason Weeda

When the comment period closed on November 7, the Food and Drug Administration’s (FDA) proposed rule on Unique Device Identification (“UDI”) generated a total of 221 comments by various stakeholders.  Although the FDA has come a long way since it first sought comments on the use of an identifier system in 2006, a review of the comments on the proposed rule suggests that the issues and obstacles remain the same six years later.

The 221 comments are as diverse as the device market itself.  As was the case when the FDA first held its public meetings on the UDI initiative, most stakeholders recognize the potential benefit of an appropriate UDI system in improving post-market surveillance of medical devices and other related benefits. However, it also appears that there remains a large split of opinion on what technology is most appropriate to achieve these benefits. The FDA has attempted to duck this issue in its rulemaking by, for example, exempting over-the-counter devices and QSR-exempt Class I devices from the production identifier requirement and by allowing for the use of multiple standards (i.e., GS1, HIBCC) for UDI. It is clear from the comments that the issue remains unsettled in the minds of stakeholders and, without clear guidance from the agency, it is uncertain how manufacturers can ensure that their chosen UDI standard will not create unforeseen regulatory risks.

Upon review of a sample of comments, it appears that most make procedural and practical suggestions regarding UDI implementation for specific devices and/or advocate for exemptions.  A few comments oppose allowing multiple standards for UDI, on the grounds that a single UDI standard and system would be easier to implement into manufacturing operations. Many comments state that the rule needs to allow more time for manufacturers to implement UDI due to cost and logistics, whereas a few state that they are already compliant with the proposed rule and that implementation should occur sooner than proposed.

Other issues include, without limitation:

  • Certain devices are difficult or impractical to mark;
  • Products labeled before the UDI rule is implemented should be exempt due to burden and expense; and
  • The ability (or lack thereof) of a remanufacturer to comply with the rule and proposals for exemptions for various reprocessed devices.

Larger companies that manufacture multi-component devices noted there is little direction regarding UDI labeling for their devices and that such labeling may not be practical.  For smaller manufacturers, many take issue with the cost of complying with the UDI rule, citing the financial crisis and the looming medical device excise tax, urging that the rule be postponed until after there is an economic recovery.  FDA has estimated the cost for domestic labelers alone to be $67-68 million per year, annualized over 10 years. Some comments, however, claim this number to be much larger.

The list goes on and on, and there are many contrasting opinions, some which may be practical for one device or manufacturer but not for another.

On November 19, the FDA unveiled an amendment to the proposed UDI rule.  The amendment accelerates the timeframe to implement UDI for some “implantable, life-supporting, or life sustaining devices.” The amendment also requires a UDI mark on implantable devices to be implemented within two years. Comments on the amendment will be accepted until December 19, 2012. The FDA also requested specific comments regarding its change in the definition of “custom devices” which are exempt from the UDI rule.  Comments to this inquiry are due January 18, 2013.

It will be a time-consuming and difficult challenge for the FDA to reconcile and address all comments in the preamble of a final rule. The fact that the FDA has amended the proposed rule and is asking for additional comments is helpful but, as a result, it is likely that we may not see a final rule for some time. What is certain is that the Agency is tasked with a delicate balancing act in considering the benefit to the public and safety risks, as well as the impact and burden on the medical device industry.

Compounding, Again

By Tish Eggleston Pahl

The election is over, cabinet re-shuffling has begun, and hopefully you properly prepared and stored your food and avoided poisoning family and friends over the Thanksgiving holiday.  As you can imagine, food preparation at a food and drug law firm is a very serious business.  We regularly swap favorite turkey brining and stuffing recipes and remind each other about safe thawing practices.  I personally recommend America’s Test Kitchen’s vodka pie crust and the Pioneer Woman’s butternut squash puree.

Moving from foods to drugs, we continue to follow the ongoing investigation into the New England Compounding Company (NECC).  As my partner, Jon Weinrieb, wrote, FDA Commissioner Margaret Hamburg testified on November 14 and 15 before the House Energy and Commerce Subcommittee on Oversight and Investigations and the Senate Committee on Health, Education, Labor and Pensions.  The FDA has been seeking to define the line between the traditional practice of pharmacy (in theory regulated by State Boards of Pharmacy) and drug manufacturing (which FDA should regulate).  Today, the FDA announced plans for a public meeting on the matter. It will also accept comments to explore these issues.

The public meeting will take place on December 19 and will be webcast.  The notice states that onsite registration begins at 2 p.m. on December 19 on a first-come, first-served basis and that the meeting will be from 3 to 5 p.m.  I’ve covered lots of FDA public meetings over the years (the ones in the wireless dead zone of the NHTSA hearing room below L’Enfant Plaza were especially memorable), and I’ve never seen one lasting only 2 hours.  Fortunately, FDA is also accepting public comments until January 18, 2013.

Echoing some of Commissioner Hamburg’s earlier remarks, the agency is focusing upon defining “traditional pharmacy compounding that should be primarily overseen by the States and higher risk non-traditional pharmacy compounding that would require compliance with Federal standards. . . .  In recognition of the States’ role, the FDA has also reached out to its State partners by inviting representatives from all 50 States to an intergovernmental meeting.”  The two-hour public meeting will follow the State intergovernmental meeting.

The agency seeks comment on three questions:

  • Given existing authorities and resources, are the States currently able to provide the needed oversight of pharmacy compounding and consumer protection?
  • What should the Federal role be in regulating higher risk pharmacy compounding such as compounding high-volumes of drugs for interstate distribution?  Is there a way to re-balance Federal and State participation in the regulation of pharmacy compounding that would better protect the public health?  What strategies should be developed to further strengthen Federal/State communications?
  • Do you see a role for the States in enforcing a Federal standard for “non-traditional” compounding?  If so, what role?  What factors would affect a decision by your State to take on such responsibility?

Given the breadth and complexity of these questions and the short, 2-hour time frame, any thoughtful response should be submitted in written comments.  We’ll be watching the public meeting and live-tweeting it!

An Idea for Barack Obama: Why Not Pick Sen. Dick Lugar as Secretary of State?

By Kenneth D. Ackerman, as published on The Huffington Post

So, President Obama, you need a new Secretary of State to replace Hillary Clinton, but you don’t like any of the choices sitting on your desk? You think Susan Rice deserves it and would do a great job, but she comes with too much controversy? You feel you owe John Kerry a favor for helping you in the campaign, but wonder if he’d fit right on your team?

How’s an idea that maybe you haven’t thought of: How about Dick Lugar?

To read the column in its entirety, click here.

Also, check out Ken’s Viral History blog!

Splish/Splash: No Original Subject Matter Jurisdiction Over EPA’s Water Transfer Rule

By Stewart D. Fried and John G. Dillard

In a decision with potentially broad implications, the Eleventh Circuit recently concluded that it lacked original subject matter jurisdiction over petitions for review of an EPA rule which freed federal, state and municipal agencies from obtaining a Clean Water Act permit for certain water transfers.  In Friends of the Everglades v. EPA, the Circuit Court addressed a challenge to EPA’s 2008 Water Transfer Rule creating a permanent exemption from the National Pollutant Discharge Elimination System (NPDES) permit program for pollutants discharged in the context of transfers from one body of water to another.  The Eleventh Circuit’s decision is the latest ruling in a seemingly never-ending series of lawsuits concerning water transfers in the Everglades.

The 2008 Water Transfer Rule was promulgated during the appeal of a Southern District of Florida injunction which required the local water management district to obtain an NPDES permit to transfer water from canals near the Everglades into Lake Okeechobee.  The district court concluded that “water transfers between distinct water bodies” constituted an “addition of a pollutant to the receiving navigable water body.”  On appeal, the Court of Appeals reversed, concluding that the Water Transfer Rule was a reasonable interpretation of an ambiguous provision of the Clean Water Act. 570 F.3d 1210 (11th Cir. 2009).

Shortly after the EPA promulgated its Water Transfer Rule, nine states, one Canadian province, the Miccosukee tribe and several environmental groups filed petitions challenging the rule in district courts in Florida and New York and before the Second and Eleventh Circuits.  After the appellate petitions were consolidated in the Eleventh Circuit and the district court cases stayed, the Court of Appeals dismissed the petitions for lack of original subject matter jurisdiction.

The Eleventh Circuit rejected the petitioners’ arguments that  §509(b)(1)(E) or (F) of the Clean Water Act – which generally provides for circuit court jurisdiction – applied.  First, in determining that §509(b)(1)(E) was inapplicable, the Court held that the water transfer rule was neither an “effluent standard” nor a “limitation” on entities engaged in water transfers.  Instead, “the rule frees the industry from the constraints of the permit process and allows the discharge of pollutants from water transfers.”  Second, the Court of Appeals rejected EPA arguments that §509(b)(1)(F), which provides for original jurisdiction over actions related to the issuance or denial of a permit applied, concluding that the rule “exempts a category of activities from the requirements of a permit and ensures that no permit will ever be issued or denied for discharge from a water transfer.”  The Eleventh Circuit left no ambiguity that it lacked “original jurisdiction to review a permanent exemption from the permit program.”  Lastly, the court soundly rejected the request to exercise “hypothetical jurisdiction,” noting that “[w]e cannot exercise hypothetical jurisdiction any more than we can issue a hypothetical judgment.”

The issue of original subject matter jurisdiction over challenges to EPA rules may soon be addressed by the Supreme Court.  On December 3, 2012, oral argument will be held in Decker v. Northwestern Environmental Defense Center, an appeal of a Ninth Circuit decision which held that a district court had original jurisdiction over a challenge to EPA’s interpretation of its ambiguous “silviculture rule.” See Northwest Environmental Defense Center v. Brown, 640 F.3d 1063 (9th Cir. 2011). The Brown and Friends of the Everglades decisions cannot be reconciled with National Cotton Council v. EPA, 553 F.3d 927 (6th Cir. 2009), in which the Sixth Circuit concluded it had original jurisdiction over a citizen’s suit in the context of its decision vacating a 2006 EPA rule exempting certain pesticide applicators from obtaining NPDES permits.  Regulated industries and environmental groups would be well served if the Supreme Court uses the Decker case as a vehicle to clarify whether challenges to permitting exemptions under the Clean Water Act should be brought before district courts under §505 or before in the circuit courts of appeal under §509.

Food Labeling Politics – What the Election Results May Mean for Your Company

By Bruce Silverglade

The election is over and the current Administration will stay in the White House.

Food labeling may not have been among the top issues on the minds of American voters.  But the election results will have an impact on food manufacturers, retailers, and restaurant operators who are concerned about the prospect of new FDA regulations, enforcement actions, and “voluntary” guidance documents.

The following FDA food labeling initiatives are likely to move during the next four years.  Some are on a “fast track” while others, let’s say are “on track” with no specific time frame for action.

Inside the Washington Beltway, the term “fast track” can mean that proposed regulations could still take more than a year to be finalized, but that final rules are likely to appear in the Federal Register in the foreseeable future.  They include regulations required by an Act of Congress, or relatively non-controversial rules that have been moving towards completion for a period of time.  I have “taken out the crystal ball” and here is what it says:

  • “Fast Track” – Menu Labeling

Congress, in a short passage tucked into the Patient Protection and Affordable Care Act (enacted in December 2010) required FDA to issue a proposed regulation requiring restaurants and “similar retail food establishments” with 20 or more locations to provide on menus or menu boards (including menu boards at drive through locations) calories for each standard menu item along with a succinct statement of suggested daily calorie intake.  Congress also told the FDA to require that establishments covered by the law provide a succinct statement of the availability of additional nutrition information similar to that found on Nutrition Facts labels on processed food packages.

Within a relatively short time frame of about four months, the FDA announced a proposed rule to  implement the requirement in April, 2011.  A major controversy ensued over the Agency’s definition of the statutory term “similar retail food establishment.”  In addition to restaurants, the Agency proposed that grocery stores, convenience stores, coffee shops, and retail confectionary stores that sell restaurant type food were subject to the law, as well.  Movie theaters, however, were exempted.

A related proposed rule by the FDA would require calorie information for vending machine food.  The agency stated that visible nutrition information at the point of purchase includes front-of-pack (FOP) nutrition symbols, provided they include calories.  More on FOP labeling below.

Consumer and health groups are pressuring the Administration to expand the scope of the proposed restaurant rule to cover movie theaters, bowling alleys, concession stands, school and hospital cafeterias, hotels, buses, trains, and planes.

Curiously, the Act gave FDA a deadline to issue a proposed rule, but did not contain a date by which the proposed rule must be finalized.      In light of the Administration’s overall goal of promptly implementing all aspects of the new health care law, it is likely that publication of a final rule  is on a “Fast Track” and will appear in the Federal Register in the foreseeable future.

  • “Fast Track” – “Gluten Free” Claims

The FDA published a proposed rule on “gluten free” claims in the Federal Register in 2007 as required by the Food Allergen Labeling and Consumer Protection Act of 2004.  Essentially, the proposed rule stated that “gluten free” means less than 20 ppm gluten.  However, the FDA reopened the comment period in 2011 to take additional comments on a safety assessment examining tolerable daily intakes and results of a consumer survey studying reactions to various types of label statements.  This is the type of rulemaking that could gather dust during a change in administrations, but probably will be finalized in the foreseeable future, given the agency’s long term interest in the issue and the stability among political appointees working in the Commissioner’s office.

  • “Slow Track” but Still Chugging Along  Updating the Nutrition Facts Panel

The Nutrition Facts Panel (NFP) is now 20 years old.  That’s old for a nutrition labeling scheme.   FDA, since 2007, has been kicking around possible changes.  Potential changes include changes to the nutrients required to be declared (e.g., requiring declaration of “added sugars,” revising the micronutrients of concern declared), updating the Daily Values for certain nutrients (e.g., changing the DV for sodium from 2,400 mg to 2,300 or, more drastically, 1,500 mg), and graphic changes (e.g., displaying calories more prominently, eliminating elements of the label that are rarely used by consumers, such as calories from fat). .

Amendments to the NFP of one sort or another are certainly needed.  The FDA career staff would like the reform initiative to move to the proposed rulemaking stage.  The matter is “on track,” but for better or worse, appears to be on the slow track.  In 1990, it took an Act of Congress to convince the Agency, which had been pondering the issue for years, to complete the first regulations for mandatory nutrition labeling by a set date — November 1992.  Arguments within the George H.W. Bush administration were so intense that the issue ultimately found its way into the Oval Office.  The President himself reviewed various options and personally chose the NFP that we see today.  The FDA published final rules for mandatory nutrition labeling and related matters about two months past the statutory deadline, in January 1993.

  • “Slow Track,” and fate indeterminate – Front of Pack (FOP) Nutrition Symbols

During the first term of the Obama Administration, policing FOP nutrition symbols used by the food industry and considering a uniform recommended FOP nutrition symbol was an agency priority.  One of the first industry-wide labeling enforcement actions taken by the Obama FDA was a Warning Letter sent to the director of the now defunct Smart Choices program.  Further, in 2010, the Institute of Medicine (IOM) issued a report on the topic,  and in 2011, made official recommendations to the Agency.

But in the interim, FDA’s interest in the issue faded.  The enactment of the Food Safety Modernization Act forced a shift in agency priorities to food safety, and the food industry’s development of the “Facts Up Front” FOP symbol effectively preempted an FDA-designed FOP label.  In December 2011, FDA sent a letter of enforcement discretion to the Grocery Manufacturers Association (GMA) and the Food Marketing Institute (FMI) about their “Facts Up Front” FOP nutrition symbols program.  The program is now scheduled to be rolled out officially sometime in 2014.

FDA has previously expressed a preference for an FOP symbol that rates the nutritional value of food rather than one that simply summarizes key information from the Nutrition Facts panel.  FDA has before it IOM recommendations for an FOP label rating based on a rating system that takes into account a food’s calorie, saturated/trans fat, sodium, and added sugars content.  If the agency decides to turn its attention back to FOP nutrition labeling, it will likely test consumer comprehension of a system based on IOM’s recommendations against the industry’s Facts Up Front program.  That may not occur, however, until 2015, after Facts Up Front has been in full use for a year.   Should FDA’s studies suggest that a FOP labeling system based on IOM’s recommendations more effectively communicate nutrition information to consumers, we should expect the announcement of a model government program — unless the clock runs out.  Consumer studies take time to conduct and evaluate, and guidance programs take time to develop and be written up for publication in the Federal Register.  It may well be 2016 until the agency has something to say on the issue.  And guess what, we will then be back in a new election year cycle.

Information from the United Kingdom, however, may be instructive.  The UK Food Standards Agency (FSA) pioneered the development of a voluntary “traffic light” labeling system for use on the FOP in 2007.  Initially, the model system was rejected by manufacturers, and most retailers.  A change in governments (from liberal to conservative) took the model traffic light system off the FSA main web site for a time and placed it under a hard to find “archives” link.  But despite political trends, market forces ultimately prevailed.  Gradually, retailers began using the government scheme on private labels and freshly prepared items sold in stores.  The result is that most major food retailers in the UK, including ASDA owned by Wal-Mart, and TESCO, the largest retailer in the UK, have agreed to use the system, with smaller retailers following in their wake, .

The development of an official FDA model FOP system, even in the last days of the President’s second term, could eventually lead to similar developments in the U.S.

Block Grants: Over Sold – Under Thought

By Marshall L. Matz and Roger R. Szemraj, as published in Agri-Pulse

There has been a lot of discussion lately about converting various food assistance programs from their current status as entitlement programs into a block grant.   This is not a new idea.  It was part of the “Personal Responsibility Act” included in Speaker Newt Gingrich’s 1995-1996 Contract with America. The Speaker proposed combining school lunch, school breakfast, WIC, and Food Stamps (now called the Supplemental Nutrition Assistance Program, or “SNAP”) into a block grant.

Earlier this year, the Fiscal Year 2013 House Budget Resolution included language that would renew this old effort to convert SNAP into a state block grant program.  On September 20, Senator Inhofe (R-OK) introduced S. 3602, the Food Stamp Restoration Act, a bill to repeal the nutrition entitlement programs and establish a block grant for SNAP.   Then, Congressman Tim Huelskamp (R-KS) was joined by eight other members in introducing HR 6567, on October 2, the State Nutrition Assistance Flexibility Act of 2012.

Block grants, on the surface, may have some appeal.  The goal of the legislation, allegedly, is to provide program flexibility and to simplify administration.  But things aren’t always what they seem.

You can read the complete article here.

Marcia Fudge, Member of House Ag Committee, to Chair Congressional Black Caucus

By Marshall L. Matz

On November 14th, the Congressional Black Caucus (CBC) unanimously elected Congresswoman Marcia Fudge (D-OH) to serve as Chair during the 113th Congress.  Rep. Fudge is the first member of the House Agriculture Committee to serve as CBC chair.

Founding Members of the Congressional Black Caucus. Source: Office of the Clerk, U.S. House of Representatives

The Alliance for a Green Revolution in Africa (AGRA), for whom we are the U.S. representative, is delighted by the election of Rep. Fudge to Chair the CBC. Given the recent Camp David Declaration and its emphasis on boosting agriculture production in Africa, the timing of her election is perfect.  She will bring an important perspective and focus.

You can read the CBC press release here.

Can FDA Regulate Compounding? FDA Doesn’t Think So. . . But It Kind of Tried To

By Jonathan M. Weinrieb

As the impact of the deadly meningitis outbreak grows, questions about FDA’s authority to regulate pharmacy compounding have arisen.

New England Compounding Center Inc.’s (NECC) tainted, injectable steroid, methylprednisolone acetate, is now linked to 461 infections, including 32 deaths.  In testimony this week before the House Energy and Commerce Subcommittee on Oversight and Investigations, FDA Commissioner Margaret Hamburg stated, in no uncertain terms, that her Agency needs additional authority to regulate compounding pharmacies.

As we noted in a prior blog post and, according to Dr. Hamburg’s testimony, FDA has deferred to State Boards of Pharmacy for regulation of traditional compounding (i.e., for a single patient pursuant to a clinician’s prescription).  Indeed, as noted by Dr. Hamburg, under the Food and Drug Administration Modernization Act of 1997 (FDAMA), compounding is exempt from several regulatory requirements: (1) premarket approval for new drugs; (2) compliance with current good manufacturing practice (cGMP); and (3) adequate directions for use.  As part of these conditions, compounding must be performed in response to a specific prescription for a specific patient.  Otherwise, as K-V Pharmaceuticals made clear in briefing and oral argument in federal court earlier this year, non-customized “compounding” of drugs is unlawful manufacture.  How then is it that FDA does not have authority to regulate non-customized compounding as seen in the case of the tainted steroid produced by NECC?

Some lawmakers questioning the Commissioner seemed skeptical that FDA lacked statutory authority.  They sharply questioned Dr. Hamburg’s testimony that clear statutory lines between traditional (i.e., customized, single-patient) and non-traditional compounding are needed.  FDAMA appears to do this.

Despite its statements to the contrary, it appears that even FDA knew it had the power to regulate NECC.  After all, it seems odd that a federal agency, especially one as strapped for resources as FDA, would waste time sending enforcement letters to entities over which it has no authority.  FDA sent a Warning Letter to NECC in December of 2006.  In addition, both FDA and the Massachusetts Board of Pharmacy investigated NECC just after complaints began to roll in – as far back as 1998 and, in the case of FDA, as far back as 2002 – the same year that FDA reissued its Compliance Policy Guide (CPG) 460.200: Pharmacy Compounding (reissued May 29, 2002).

Although a 2011 federal court ruling (U.S. v. Franck’s Lab, Inc., M.D. Fla.) is consistent with the notion that FDA lacks the authority to regulate pharmacy compounding, that decision was recently vacated.  The appellate hearing scheduled for Nov. 1st before the Eleventh Circuit was, accordingly, mooted on grounds far afield from the merits (i.e., Franck’s is out of business).  Without the Eleventh Circuit to determine Franck’s (and his compounding brethren’s) regulatory fate, for now, we are left with yesterday’s somewhat contentious showdown on Capitol Hill.

So . . . does FDA have the authority to regulate pharmacy compounding of drugs when it is not customized for a particular patient?  Given the magnitude of this outbreak, time (and we may not need much) will tell.

History Suggests Grand Bargain to Avert Fiscal Cliff

U.S. presidents have faced, and overcome, heavy debt loads in the past. Source: Library of Congress Prints and Photographs Division

By Kenneth D. Ackerman, as published in Bloomberg News.

The “fiscal cliff,” a combination of tax increases and severe spending cuts scheduled to kick in next year, is a product of multiple deceptions. Both the expiration date on the Bush-era tax cuts and the trillion-dollar “sequesters” that were enacted as part of last year’s debt- ceiling deal were designed to cover up an overarching problem: the country’s out-of-control debt.

The U.S. government today owes $16.05 trillion to bondholders and creditors, more than $51,000 for every American. This debt is already larger than the country’s annual economic output and threatens to cripple the economy for generations.

To read the column in its entirety, click here.

Also, feel free to check out Ken’s Viral History blog.

BPA: The Press Rounds Up the Usual Suspects and Gets it Wrong

By Mark L. Itzkoff

Over the past few months, articles have been published claiming possible links between bisphenol A (BPA) and a variety of human health problems including obesitythyroid changes, and male infertility.  Many of the recent stories leave consumers misinformed about possible exposure to BPA and implicate products that do not contain BPA.

For example, NBC News recently aired a report on the possible link between BPA and lower thyroid hormone levels.  During the story introduction, the backdrop images behind the news anchor were first disposable plastic water bottles, followed by a dump truck unloading its collection of post-consumer plastic for either recycling or disposal, again mainly disposable water bottles.  Consumers could easily infer that both the disposable plastic water bottles and plastic products produced using recycled, post-consumer materials are possible sources of BPA exposure.  This implication is simply incorrect.

What is BPA?

Bisphenol A (in FDA’s food additive regulations, 21 CFR 175 et seq, BPA is listed using the chemical name 4,4’-isopropylidenediphenol) is a highly reactive chemical that is primarily used as a monomer in the production of polycarbonate plastic and epoxy coatings.  During polycarbonate production and the application of epoxy coatings, BPA reacts with other monomers to form the plastic or coating.  BPA is not used in the production of other food packaging plastics, such as polyethylene terephthalate (PET or PETE), polyethylene, polypropylene or polystyrene.

What is a “water bottle?”

Much of the misinformation regarding BPA exposure appears to be due to the use of the term “water bottle” for different products.  There are two containers that are often referred to as “water bottles”:

  • Pre-filled, single-use, disposable bottles such as the common 0.5 liter bottle; and
  • Bottles that are sold empty, intended to be filled and re-used by the consumer with water or other beverages.

Different materials are used to produce each type of water bottle.

Single-use bottles are produced from PET, which, as noted above, is a polymer that is produced without BPA.  Because there is no BPA in the container, consumers are not exposed to BPA when drinking water or other beverages packaged in PET containers.

On the other hand, reusable water bottles have been produced from a number of different materials. Prior to 2003, multi-use, refillable bottles were often produced from polycarbonate, a hard plastic that did not impart the “off-taste” sometimes associated with plastic containers.  However, following media reports of possible BPA migration from these bottles, virtually all U.S. suppliers converted to other materials, such as metal and glass.  When the media reports on possible health risks due to BPA exposure from “water bottles,” the reporters are referring to these reusable bottles made with polycarbonate which are no longer being sold.

It should be noted that polycarbonate was also used to produce baby bottles and “sippy cups.”  U.S. companies and their suppliers stopped using polycarbonate in these applications following publication of a study in 2008 reporting that polycarbonate baby bottles could release “dangerous levels” of BPA.  Earlier this year, the Food and Drug Administration amended its regulations and removed the earlier clearance for the use of polycarbonate resin in baby bottle and sippy cup applications.  The FDA took this action in response to a petition from the American Chemistry Council (ACC) in which ACC stated that polycarbonate is no longer used to produce baby bottles and sippy cups, not as a result of any agency determination that the use of these products is unsafe.