An Update on US Pharmacopeia’s Heavy Metals Testing

September 20th, 2010 by FrontierGS

As many of you know, USP has been working for several years to replace the current General Chapter addressing heavy metals (231).  The proposed new general chapters include:

  • General Chapter <232> which addresses the Limits of Elemental Impurities (heavy metals).
  • General Chapter <233> which addresses the Procedures to be used when analyzing the Elemental Impurities (heavy metals).

As a laboratory exclusively focused on heavy metals, we get quite a few phone calls regarding these new General Chapters.  As such, we thought we’d attempt to answer some of the more frequently asked questions.

General Chapter <232> and <233> – The 5 Most Frequently Asked Questions…

The US Pharmacopeia proposed General Chapters for heavy metals (elemental impurities) in pharmaceuticals is intended to replace the current General Chapter <231>.  While there are three proposed new General Chapters, most of the questions we get surround General Chapter <232> which deals with limits and General Chapter <233> which deals with procedures.  Here are 5 frequently asked questions…

1. Why the new regulations?

To start off with, it is not just the pharmaceutical industry that is seeing the regulatory environment increasing for heavy metals.  We are seeing more heavy metals regulations in pharmaceuticals, nutraceuticals, food and beverage, and personal care products.  We feel the common denominators dictating increased regulations can be distilled down to the following three drivers.

First, as the trend in healthy living and natural care continues to grow, consumers are becoming much more aware of what they are putting in their bodies.  Increasingly, they are demanding to know exactly what is in the products they are purchasing.  This includes all industries mentioned above.  No longer are consumers waiting for manufacturers to test and report.  In many cases, consumer groups are simply purchasing products and having them tested independently.

Next, the current method for testing heavy metals in pharmaceuticals is over 100 years old.  The advancement’s in heavy metals testing over the last century is significant.  The methods available today are sound, robust and cost-effective.

Finally, exposure to heavy metals as a population has been a long-standing health concern.  The ability to test for these metals at extremely low levels (highly-sensitive) allows consumers, manufacturers and regulators the visibility necessary to ensure products are safe.

2. What testing methods are required for the proposed General Chapter <233>

The US Pharmacopeia (USP) does not require a specific method be used in the testing of heavy metals.  Instead, the method a company uses is based on performance.  The performance criteria used to evaluate the performance of a given test is relatively complex and would require pages to explain.

Having said that, there are some very well documented tests that represent a good combination of accuracy and efficiency the industry seems to be trending toward.  These tests are ICP/MS (Inductively Coupled Plasma – Mass Spectrometry) and typically utilize microwave digestion methods.  Again, as a manufacture you can choose whatever method of testing that meets your needs and the specific performance criteria establish by the USP in their proposed General Chapter <233>.

3. Who will enforce the new General Chapters?

The USP is very specific in that they are not a regulatory agency.  They are a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States.  As a result, the Food and Drug Administration is intended to be the regulatory agency responsible for the enforcement of USP’s General Chapters 232 and 233.

4. What is the timing for General Chapters  <232> and <233>?

That is a great question.  Several things need to happen prior to USP General Chapters <232> and <233> replace the existing General Chapter <231>.  First, the final comments need to be reviewed.  Based on those comments it is anticipated that the actual General Chapters will be formally published.  Once the General Chapters are published there is typically a period provided for the implementation of the new standards.  There are a host of variables that could either slow down or speed up this process.  It appears the General Chapters will be published sometime during the first half of 2011.  The subsequent implementation process is a little less clear at this point.

We try to stay in close touch with new developments regarding the proposed USP General Chapters 232 and 233.  As new information becomes available we will certainly pass it along.

5. What Metals do we need to test for?

There are two categories or “classes” listed in the proposed General Chapter for Elemental Impurities.  The first, Class 1 specifically addresses four different metals.  They are arsenic, cadmium, lead and mercury.  According to the drafts, testing for these metals “is required for all drug products, regardless of the likelihood of the presence of impurities.”

The next is Class 2.  These are heavy metals (elemental impurities) that “need to be conducted only when these elements are added during the manufacture of the article.” In other words, if you add any of the elements listed in Class 2 you are required to test them.  If you don’t add any of the elements listed in Class you, you need not test.

We hope this information has been helpful.  If you have any questions regarding heavy metals testing, please let us know. To learn more about heavy metals testing, contact us or request a quote now.

About Frontier – Frontier Global Sciences is an internationally recognized analytical laboratory, specializing in the analysis of trace metals or heavy metals in industrial, environmental and consumer applications.  For over 18 years the company has provided innovative solutions and “gold standard” analytical services to corporations and government entities throughout the world.

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Safe Cosmetics Act of 2010 – Are you ready?

August 10th, 2010 by FrontierGS

In mid-July Congressman Ed Markey of Massachusetts, Jan Schakowsky of Illinois and Tammy Baldwin of Wisconsin filed a bill designed to get harmful chemicals out of personal care products. The proposed Safe Cosmetics Act of 2010 would require companies to conduct safety testing of the ingredients they use and include a full, detailed list of ingredients on their websites and product labels.

Additionally, the proposed law would require the U.S. Department of Health and Human Services to conduct random testing for contaminants in cosmetics and personal care products. It would further require companies to report adverse health issues from their products to the Food and Drug Administration. Finally, it would give the FDA the authority to issue recalls for products that fail to meet specific safety standards.

In talking with a number of our clients in the Cosmetic and N&OPC product industries, the general consensus is that additional oversight is inevitable. The question is when and in what form.

So, what is a manufacturer in this industry to do? Below are a few things to think about…

  1. Educate Yourself – Review warning letters, inspection reports, compliance correspondence, etc. to understand if there are things you can begin doing today that will better prepare and protect your company.
  2. Ensure Current Compliance – Make sure you fully understand the FPLA (Fair Packaging and Labeling Act) and FD&C (Federal Food, Drug & Cosmetic Act). Additionally, review your compliance with GMP’s (Good Manufacturing Practices). While there are no regulations set forth specific to GMP requirements for cosmetics much of what is contained in the GMP’s will ensure safe practices.
  3. Embrace Potential Challenges – When it comes to contaminants (including heavy metals) in your products it pays to be proactive. With consumer activists purchasing products off store shelves and independently testing them, sound knowledge of your products safety and quality is an absolute must. Your brand depends on it.

If you focus on the three items above you will proactively put your company in a stronger position for any upcoming regulations. To learn more about how Frontier Global Sciences might support your efforts give us a call or send an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

About Frontier – Frontier Global Sciences is an internationally recognized analytical laboratory, specializing in the analysis of trace metals or heavy metals in industrial, environmental and consumer applications. For over 18 years the company has provided innovative solutions and “gold standard” analytical services to corporations and government entities throughout the world

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Third Party Testing – Offense or Defense?

June 29th, 2010 by FrontierGS

It doesn’t seem like a day goes by without a story in the news about heavy metals in a consumer product. Whether legitimate or not, this can be catastrophic for the targeted company.

That is unless the company has taken some straight forward tests to protect itself. After almost 20 years as a preeminent heavy metals laboratory we’ve learned a few things that may be helpful.

First, testing for heavy metals can be tricky. Armed with the right technology to test heavy metals but lacking the wisdom to understand the variables can produce inaccurate results – in many cases results that are not in your favor. This can create both “false positives” and false negatives”. Neither of which are desirable.

Third party testing is perhaps the most cost effective insurance a company can buy. A perfect demonstration of this comes in the form of recent feedback from a client of ours. They were approached by the media who had “unconfirmed reports” of excessive heavy metals in their product.

While this scenario may have been “rattling” for some, our client shared with us they simply showed the writer the documentation from our Gold Certification program, shared that Frontier was a leading heavy metals laboratory and ISO 17025 accredited. Bottom-line, we understand that was the end of the story.

I share this with you, because I think it is important. An ounce of prevention is worth a pound of cure. In this case, being able to confidently communicate that they had proactively brought in a third party to monitor their products was worth significantly more than the $100 BIG 4 test. Avoiding the potential damage to a company’s brand could easily be worth 100 or even 1,000 times the price of that test.

If you currently have a solid heavy metals testing program in place – good for you! If you don’t it’s a great time to get started. Give us a call today and we’ll share ways we see existing clients creating the most cost effective testing programs.

To learn more about heavy metals testing, contact us or request a quote now.

About Frontier – Frontier Global Sciences is an internationally recognized analytical laboratory, specializing in the analysis of trace metals or heavy metals in industrial, environmental and consumer applications.  For over 18 years the company has provided innovative solutions and “gold standard” analytical services to corporations and government entities throughout the world.

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Heavy Metals Testing – Changes are Coming

June 16th, 2010 by FrontierGS

Driven in part by consumer demand, a better understanding of heavy metals and the ever increasing global manufacturing of pharmaceuticals, the regulatory landscape is poised to change dramatically.

It isn’t just pharmaceuticals.  Dietary supplements, cosmetics and consumer products (to name a few) are all industries experiencing increased regulatory oversight of heavy metals.

However, regulatory compliance may not be the biggest issue.  In today’s self-publishing world, news (warranted or not) travels like wildfire.  We’ve all seen mega-brands brought to their knees by a groundswell on the Internet.

Today – safety and quality are a competitive advantage AND a necessity to protect your company and your brand.

In many cases, third-party heavy metals testing may be one of the most cost effective ways to evidence quality and protect your brand.  Heavy metals testing has come a long way in the last decade.

Having participated in a number of workshops dealing with heavy metals (Sponsored by USP) over the last several years, I will offer that the proposed changes would seem to be an advantage to the industry.  Let me explain…

The current method (general chapter 231) is based on 100 plus year old technology.  The results can be subjective.  The proposed methods will allow pharmaceutical companies to do the following:

  • Analyze for heavy metals as significantly lower levels
  • Quantify the results at ppb levels (parts per billion)
  • Do so with quick turnaround times and very competitive prices

    We are all aware of the current environment.  The media has taken an ever critical role of pharmaceutical and nutraceutical companies.  Historically, these industries have been given an “automatic pass” by consumers.  If it was prescribed by a doctor or a vitamin on the shelf, everyone just knew it had to be good.

    I think we all know times have changed.  Pharma and nutra companies are no longer given that “automatic pass”.  Metals, even at extremely low levels are being questioned by consumers and regulators.

    Having the ability to evidence a comprehensive and quantifiable third-party testing program should be viewed as the most cost effective insurance a pharmaceutical lab can buy.

    For this reason, many of our more progressive clients (Pharma and Nutra) have taken a proactive stance in terms of heavy metals testing.  We applaud them.  If you are interested in learning more about establishing a comprehensive third party testing program, let us know!

    To learn more about heavy metals testing, contact us or request a quote now.

    About Frontier – Frontier Global Sciences is an internationally recognized analytical laboratory, specializing in the analysis of trace metals or heavy metals in industrial, environmental and consumer applications.  For over 18 years the company has provided innovative solutions and “gold standard” analytical services to corporations and government entities throughout the world.

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    Heavy Metals in Dietary Supplements a Competitive Advantage?

    April 19th, 2010 by FrontierGS

    Mercury and other heavy metals in dietary supplements and herbal products are a growing concern for consumers, clinicians and Nutra manufacturers alike. While the problem is real there are some proactive and positive ways to embrace this issue.

    In upcoming newsletters and blogs we’ll talk about things like limits for daily consumption, high-risk products and acceptable testing methods. However, today we are simply going to take a “macro” look at this issue.

    A few months ago, the United States Geological Survey published the results of a study in which it tested fish from 291 streams across the country. The results – there was mercury in 100% of the fish tested. Moreover, one-fourth of the fish tested had mercury levels higher than what’s considered healthy for people who eat fish regularly.

    So, where does mercury and other heavy metals come from? Let’s start with mercury. Essentially, mercury comes in three flavors – elemental, inorganic and organic.

    Elemental Mercury – comes from industrial exposure. This would include old thermometers, electrical switches, and fluorescent bulbs.

    Inorganic Mercury – is the ionic form that is combined with an anion like chlorine, sulfur or oxygen to make a powder or crystal. In the past it was used as an antiseptic, in many creams and as a preservative.

    Organic Mercury – is bound to an organic compound such as methyl or ethyl. Organic mercury naturally “lives” in our environment.

    What does all this have to do with dietary supplements? Actually, quite a bit

    As the trend in healthy living and natural care continues to explode, consumers are becoming much more aware of what they are putting in their bodies. Increasingly, they are demanding to know what is in the products they are ingesting. Not just whether the product passes a limit test, but what heavy metals are present.

    They say the best defense is a good offense. Well, “they” are spot on when it comes to heavy metals in dietary supplements. Some heavy metals are bio-accumulative. This simply means there is no way for your body to “purge” them. The levels in your system may increase, however they’ll never decrease.

    As a result, extremely low levels over a long period of time can have a significant impact on the human body. Most dietary supplements and herbal products are based on raw materials that are grown or harvested. In many cases, theses raw products are natures “filter”. The mercury in our atmosphere (rain and air) can be deposited on these raw products.

    Instead of viewing heavy metals in your dietary supplements as a challenge, view extremely clean products as a competitive advantage.

    You may be thinking “yeah, but it is cost prohibitive to test for heavy metals at such low levels”. Historically, you may have been right. However, in recent years both technology and know-how have made extremely low level heavy metal testing extremely accurate and affordable.

    Again, stay posted as we drill-down into methods, best practices, mistakes to avoid, and how you can use this information to deliver a superior product with a competitive advantage.

    To learn more about heavy metals testing, contact us or request a quote now.

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    Supplements – Using Quality to Build your Brand

    April 19th, 2010 by FrontierGS

    Quality in your BrandPrice takes a back seat to safety…

    As the media continues to highlight cautionary findings related to dietary supplements, consumers are focusing on quality and safety like never before.

    This trend was confirmed in a recent survey completed by Chicago based Colman Brohan Davis, Inc.

    Results of the survey showed that consumers ranked Safety as the Number One criteria in purchasing dietary supplements. Moreover, the majority of those surveyed acknowledged having some concerns about taking dietary supplements.

    Equally as telling was the fact that those surveyed ranked Price as the Last Consideration when purchasing dietary supplements.

    There are a few nuggets we can extract from these consumer trends. First, safety and quality really are a competitive advantage. Next, consumers appear to be willing to pay for it. If safety is the #1 consideration, this is an opportunity to differentiate your brand AND increase your margins at the same time.

    Consumers no longer view vitamins and supplements as “automatically good”. The trend is to question everything. Again, the good news is they are willing to vote for quality products with their dollars!

    This, combined with the current economic climate that is forcing more consumers to take control of their own health has created a great opportunity for the nutraceutical industry.

    How can you take advantage of this? There are a number of ways, however we’ll distill it down to three action items…

    1. Start with Quality – Clearly, a quality product begins with quality ingredients. Testing for heavy metals is something many manufacturers do as a result of California’s Prop 65 – however, making it the backbone of your brand can produce very positive results. After all, consumers are making it the #1 driver in their decision to purchase a particular product.
    2. Validate your Quality – Using a third party to validate the quality of your products is one of the most cost effective ways to build consumer confidence (check out our Gold Certification Program).
    3. Differentiate with Quality – Communicate your commitment to quality. Again, letting consumers know that you deliver safe, clean and quality products addresses their #1 concern.

    If item #2 sounds like a shameless plug, perhaps it is. However, having a good testing program in place is no longer a good idea, its table stakes to a thriving brand. We understand this and are work very hard to track the trends and industry regulations and to put our clients in a leading position.

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    Mercury in your Cement Kilns?

    April 19th, 2010 by FrontierGS

    When it comes to an industry being scrutinized by environmental and regulatory groups, knowledge really is power. Just as the cement industry is currently in the environmental cross-hairs, we’ve seen the same thing in a number of other industries over the last several decades.

    An example of this is the Wastewater business. A few years back, the wastewater industry was believed to be one of the largest environmental point source polluters of mercury. Based on bad information from outdated sampling and analysis techniques the industry was prepared for the worst. Upon further analysis using ultra-clean low level analysis we were able to show the wastewater industry was much cleaner than originally anticipated.

    The outcome was very positive. Read the rest of this entry »

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