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	<title>Ingredient Identity Testing</title>
	<updated>2012-02-05T23:31:12Z</updated>
	<id>http://blog.ingredientidentity.com/atom.aspx</id>
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	<entry>
		<title>About Ingredient Identity</title>
		<link rel="alternate" href="http://blog.ingredientidentity.com/2011/11/05/about-ingredient-identity.aspx?ref=rss" />
		<id>tag:blog.ingredientidentity.com,2011-11-05:8a857c80-fb0f-4cc0-bfa6-962c4a6bb6ab</id>
		<author>
			<name>Jim Lassiter</name>
			<email>fierceshade@yahoo.com</email>
		</author>
		<updated>2011-11-05T21:58:37Z</updated>
		<published>2011-11-05T21:58:37Z</published>
		<content type="html">&lt;div&gt;Welcome to Ingredient Identity&lt;/div&gt;&lt;div&gt;&lt;br&gt;&lt;/div&gt;&lt;div&gt;&lt;a href="http://www.ingredientidentity.com" target="" class=""&gt;www.IngredientIdentity.com&lt;/a&gt; was launched to help companies improve and ensure the Quality of their products meanwhile navigating the FDA cGMP regulations in the Food and Natural Products Industry. &amp;nbsp;&lt;/div&gt;&lt;div&gt;&lt;br&gt;&lt;/div&gt;&lt;div&gt;&lt;br&gt;&lt;/div&gt;&lt;div&gt;Ingredient Identity Specializes in:&lt;/div&gt;&lt;div&gt;&lt;br&gt;&lt;/div&gt;&lt;div&gt;&lt;ul&gt;&lt;li&gt;REGULATORY SERVICES&lt;/li&gt;&lt;ul&gt;&lt;li&gt;cGMP &amp;amp; Regulatory Notice and Support with FDA, USDA and EPA&lt;/li&gt;&lt;li&gt;FDA Inspection Support, Litigation Support and Expert Witness&lt;/li&gt;&lt;li&gt;Quality Systems Design &amp;amp; Implementation of cGMPs&lt;/li&gt;&lt;/ul&gt;&lt;/ul&gt;&lt;/div&gt;&lt;div&gt;&lt;ul&gt;&lt;li&gt;ORGANIZATIONAL SERVICES&lt;/li&gt;&lt;ul&gt;&lt;li&gt;Product Design/Ingredient Risk Evaluations&lt;/li&gt;&lt;li&gt;Ingredient Identity Testing and Botanical Identity Testing Strategy&lt;/li&gt;&lt;li&gt;Raw Material Qualification SOP, Manufacturer SOP&lt;/li&gt;&lt;/ul&gt;&lt;/ul&gt;&lt;ul&gt;&lt;li&gt;LITIGATION &amp;amp; PATENTING&lt;/li&gt;&lt;ul&gt;&lt;li&gt;New Ingredient Filings (GRAS, NCE, etc.)&lt;/li&gt;&lt;li&gt;Patent Development and Filing (Formulation, NCE, Structure Function Claims)&lt;/li&gt;&lt;li&gt;Ingredient and Label Claims and Supplement Facts&lt;/li&gt;&lt;/ul&gt;&lt;/ul&gt;&lt;div&gt;For more information, please visit &lt;a href="http://www.ingredientidentity.com"&gt;www.ingredientidentity.com&lt;/a&gt; or &lt;a href="http://site.ingredientidentity.com/Contact_Us.html" target="" class=""&gt;contact us&lt;/a&gt;!&lt;/div&gt;&lt;/div&gt;</content>
	</entry>
	<entry>
		<title>We’re from the FDA and We Want to Make Things Easier for You.</title>
		<link rel="alternate" href="http://blog.ingredientidentity.com/2009/06/02/were-from-the-fda-and-we-want-to-make-things-easier-for-you.aspx?ref=rss" />
		<id>tag:blog.ingredientidentity.com,2009-06-02:29a8f872-8a4c-4766-abba-7a2ab787642a</id>
		<author>
			<name>Jim Lassiter</name>
			<email>fierceshade@yahoo.com</email>
		</author>
		<category term="Threats to Industry" />
		<category term="FDA Actions" />
		<category term="Regulatory Need to Know's" />
		<category term="FDA and You" />
		<category term="Legislation" />
		<updated>2009-06-02T20:28:00Z</updated>
		<published>2009-06-02T20:28:00Z</published>
		<content type="html">The FDA just published an inquiry in the Federal Register to the makers of Dietary Supplements ostensibly to determine if the submission of so-called “structure/function” claims to FDA is a burden.&amp;nbsp; Please make no mistake:&amp;nbsp; It’s a trick question&lt;br&gt;&lt;br&gt;Why is it tricky?&amp;nbsp; Well there are three possible answers to the question and choosing the correct one is just the first step.&amp;nbsp; We will discuss this more but first a little background.&lt;br&gt;&lt;br&gt;When &lt;b&gt;DSHEA&lt;/b&gt; passed in October of 1994 it AMENDED the Federal Food, Drug and Cosmetic Act (FFDCA) in some very specific ways.&amp;nbsp; Sometimes and frankly too often, DSHEA is referred to as a stand-alone piece of legislation and an entity unto itself.&amp;nbsp; The reality is that it amended an existing piece of legislation in some very important ways.&amp;nbsp; One of these was in the area of claims that can be made for Dietary Supplements EXCLUSIVELY.&amp;nbsp; Foods are not allowed to make these claims nor are drugs.&amp;nbsp; Just Dietary Supplements.&amp;nbsp; These claims are now called “structure/function claims. &amp;nbsp;&lt;br&gt;&lt;br&gt;Rather than opine about what the Law means we shall accept the FDA interpretation for a moment regarding this class of claims and take a look at what DSHEA did in amending the Law regarding these claims.&lt;br&gt;&lt;br&gt;Quoting directly from DSHEA as it was passed:&lt;br&gt;&lt;br&gt;&lt;i&gt;“Section 403(r)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(1)) is amended by adding the following new sentence at the end: ‘For purposes of this subparagraph, a statement for a dietary supplement shall not be considered a claim of the relationship of a nutrient or dietary ingredient to a disease or health-related condition if the statement does not claim to diagnose, prevent, mitigate, treat, or cure a specific disease or class of diseases. A statement for a dietary supplement may be made if the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient.' ”&lt;br&gt;&lt;/i&gt;&lt;br&gt;Now this got translated into the language and references within the existing Law (&lt;b&gt;FFDCA&lt;/b&gt;) but the intent of the legislation is clear in the plain language of the amendment.&amp;nbsp; When you look at the amended language of Section 403(r)(1) of FFDCA it comes out like this:&lt;br&gt;&lt;br&gt;&lt;i&gt;(r)&amp;nbsp;&amp;nbsp; &amp;nbsp;Nutrition levels and health-related claims.&lt;br&gt;(1)&amp;nbsp;&amp;nbsp; &amp;nbsp;Except as provided in clauses (A) through (C) of subparagraph (5), if it is a food intended for human consumption which is offered for sale and for which a claim is made in the label or labeling of the food which expressly or by implication—&lt;br&gt;(A)&amp;nbsp;&amp;nbsp; &amp;nbsp;characterizes the level of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food unless the claim is made in accordance with subparagraph (2), or &lt;br&gt;(&lt;img src="http://blog.ingredientidentity.com/emoticons/cool.png" border="0" /&gt; &amp;nbsp;&amp;nbsp; characterizes the relationship of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food to a disease or a health-related condition unless the claim is made in accordance with subparagraph (3) or (5)(D).&lt;br&gt;A statement of the type required by paragraph (q) that appears as part of the nutrition information required or permitted by such paragraph is not a claim which is subject to this paragraph and a claim subject to clause (A) is not subject to clause (&lt;img src="http://blog.ingredientidentity.com/emoticons/cool.png" border="0"&gt;.&lt;br&gt;&lt;br&gt;&lt;/i&gt;This is quite a bit different in linguistic terms than DSHEA itself as passed but the reasons are it is an amendment and had to be fit into place.&amp;nbsp; No bother.&amp;nbsp; What is important is that the claims themselves are identified now in Section 403(r)(6) as follows.&lt;br&gt;&lt;br&gt;&lt;i&gt;"(6)&amp;nbsp;&amp;nbsp; &amp;nbsp;For purposes of paragraph (r)(1)(&lt;img src="http://blog.ingredientidentity.com/emoticons/cool.png" border="0" /&gt;, a statement for a dietary supplement may be made if—&lt;br&gt;(A)&amp;nbsp;&amp;nbsp; &amp;nbsp;the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient,&lt;br&gt;(&lt;img src="http://blog.ingredientidentity.com/emoticons/cool.png" border="0" /&gt; &amp;nbsp;&amp;nbsp; the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and the statement contains, prominently displayed and in boldface type, the following: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.". &lt;br&gt;A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made."&lt;br&gt;&lt;br&gt;&lt;/i&gt;Now here is where it gets interesting.&amp;nbsp; You see the FDA is now making an inquiry as to whether the burden of notifying the agency concerning these claims is too much.&amp;nbsp; They are obviously concerned about the terrible price we in the industry must pay for having to send off these letters and so forth.&amp;nbsp; Nonsense.&amp;nbsp;&amp;nbsp; This is precisely why FDA’s latest inquiry is a trick question.&amp;nbsp; First let’s look at the inquiry and what FDA wants to know:&lt;br&gt;&lt;br&gt;The FDA is inviting comment on the following:&lt;br&gt;•&amp;nbsp;&amp;nbsp; &amp;nbsp;whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;&lt;br&gt;•&amp;nbsp;&amp;nbsp; &amp;nbsp;the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;&lt;br&gt;•&amp;nbsp;&amp;nbsp; &amp;nbsp;ways to enhance the quality, utility, and clarity of the information to be collected;&lt;br&gt;•&amp;nbsp;&amp;nbsp; &amp;nbsp;ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.&lt;br&gt;&lt;br&gt;FDA said it believes the burden on industry of this information collection is “minimal” as the information required is immediately available to companies.&lt;br&gt;&lt;br&gt;Now let’s look at the three possible answers:&lt;br&gt;&lt;br&gt;&lt;b&gt;POSSIBLE ANSWER 1.&amp;nbsp; SILENCE&lt;/b&gt; – not saying a word in response to the FDA inquiry is an available option. &lt;br&gt;However you should be aware that your trade associations are going to say something – that’s part of what you have them around for.&amp;nbsp; Without your input they will make up their own mind as to the best answers and provide a whole pile of detail surrounding each piece of the inquiry and those inputs may not align with your desires or your positions.&amp;nbsp; You participate in trade associations (or should) for a reason – to get your voice heard.&amp;nbsp; Therefore silence is not golden.&lt;br&gt;&lt;br&gt;&lt;b&gt;POSSIBLE ANSWER 2.&amp;nbsp; YES&lt;/b&gt; – this is a burden to us as manufacturers to have to notify the FDA of each of our claims.&amp;nbsp; We suffer mightily and wish this burden be lifted.&amp;nbsp; By the way, now that you ask – the information submitted will not have practical utility and is not truly necessary for the performance of FDA’s functions.&lt;br&gt;Well – guess what.&amp;nbsp; This “burden” comes not from the regulations (the things we most often refer to and think of when we think of the notification of structure/function claims (21CFR Section 101.93) but rather the mandate comes from the Law itself.&amp;nbsp; Thus in order to remove the burden, you must also change the Law.&amp;nbsp; It is not enough to simply lift the section out of the Code of Federal Regulations.&amp;nbsp; As you can see in the Law as it exists today, there would be a need for actual statutory change.&amp;nbsp; Once Congress gets to tinker with legislation, there is no telling what the outcome might be.&amp;nbsp;&amp;nbsp; A simple amendment can get way out of hand.&amp;nbsp; There are other linkages within FFDCA to this little “burdensome” section that would also require change and those changes officially open up the ability to remove all traces of DSHEA from FFDCA.&lt;br&gt;&lt;br&gt;&lt;b&gt;POSSIBLE ANSWER 3.&amp;nbsp; NO&lt;/b&gt; – there is no problem with our having to notify each of these claims.&amp;nbsp; We hold the substantiation and are more than happy to continue submitting.&amp;nbsp; Thank you for your concern over our expenditure of time and effort.&lt;br&gt;All right – this aligns with FDA’s position in the inquiry that it is not a burden to submit these notifications.&amp;nbsp; What you need to ask yourself is whether you are notifying all of the claims you are supposed to and whether you do hold the substantiation necessary.&amp;nbsp; Remember that there is a Guidance that issued in January discussing FDA’s current thinking on the matter of what the substantiation requirements should be.&amp;nbsp; This development has yet to play out in its entirety.&amp;nbsp; Lastly you also should support the notion that indeed this information is of extreme practical utility for FDA.&lt;br&gt;&lt;br&gt;&lt;b&gt;Here’s what you need to know:&lt;/b&gt;&amp;nbsp; FDA is thinking hard about the whole “structure/function” claims arena and all that it entails.&amp;nbsp; There are some deeper issues surrounding the matter you are likely not aware of either that are not the topic of this blog.&amp;nbsp; The message therefore, is simple:&lt;br&gt;&lt;br&gt;Your &lt;b&gt;&lt;i&gt;BEST POSITION&lt;/i&gt;&lt;/b&gt; to advocate to your trade associations for response is a simple response of: &amp;nbsp;&lt;br&gt;&lt;br&gt;&lt;b&gt;&lt;i&gt;“NO, you are not unduly burdened by the requirements of the Law to provide notification.”&lt;/i&gt;&lt;/b&gt;&lt;br&gt;&lt;br&gt;Please note that this is neither an advocacy of nor a reference to the section of the CFR that is in place.&amp;nbsp; Advocating conformance to the Law is not a burden.&amp;nbsp; Such conformance part of how this responsible industry performs.&amp;nbsp; If you must elaborate further, discussion of electronic submission of the notification (not the substantiation but the actual notification) is an acceptable position.&amp;nbsp; Leave the rest of it alone.&amp;nbsp; Most particularly, leave issues of the regulation (&lt;i&gt;21CFR Section 101.93&lt;/i&gt;) itself aside and &lt;b&gt;DO NOT EVEN MENTION IT.&lt;/b&gt;&amp;nbsp; Next, continue as you have with your substantiation and notification process.&lt;br&gt;&lt;br&gt;The topics of “structure/function” claims and their substantiation requirements are getting hotter and hotter these days.&amp;nbsp; It is important to the overall health of DSHEA that each address of question and each action taken concerning these claims are done carefully.&lt;br&gt;&lt;br&gt;</content>
		<summary>The FDA just published an inquiry in the Federal Register to the makers of Dietary Supplements ostensibly to determine if the submission of so-called “structure/function” claims to FDA is a burden.&amp;nbsp; Please make no mistake:&amp;nbsp; It’s a trick question&lt;br&gt; ...</summary>
	</entry>
	<entry>
		<title>You Know Something's Happening, But You Don't Know What It Is . . .</title>
		<link rel="alternate" href="http://blog.ingredientidentity.com/2009/05/28/you-know-somethings-happening-but-you-dont-know-what-it-is---.aspx?ref=rss" />
		<id>tag:blog.ingredientidentity.com,2009-05-28:81ad6087-0341-4b55-b22a-17ef86ec59e6</id>
		<author>
			<name>Jim Lassiter</name>
			<email>fierceshade@yahoo.com</email>
		</author>
		<category term="Threats to Industry" />
		<category term="FDA and You" />
		<category term="Legislation" />
		<updated>2009-05-28T17:34:00Z</updated>
		<published>2009-05-28T17:34:00Z</published>
		<content type="html">While the industry is approaching the preparation for enforcement of the Dietary Supplement GMPs with its usual 11th hour strategy of action just before the hammer falls – another happenstance has surfaced.&amp;nbsp; This one could have some significance and could be the death knell for a portion of DSHEA if not the whole of it.&amp;nbsp; For those of you who believe that this is Chicken Little speaking – please note that this legislation has notable impact and the odds are you are only dimly aware of it.&lt;br&gt;&lt;br&gt;On May 26, 2009 our friends in Congress (Mr. Waxman and Mr. Dingell specifically) &lt;a href="http://energycommerce.house.gov/index.php?option=com_content&amp;amp;view=article&amp;amp;id=1631:waxman-dingell-and-pallone-release-food-safety-enhancement-act-of-2009-draft&amp;amp;catid=122:media-advisories&amp;amp;Itemid=55"&gt;introduced&lt;/a&gt; a bit of legislation that is designed to make the public feel safer concerning their food.&amp;nbsp; On the heels of salmonella in spinach and melamine in infant formula, this timely presentation is understandable.&amp;nbsp; Without an extensive reading of the draft legislation this sure sounds like a good idea.&amp;nbsp; &lt;a href="http://energycommerce.house.gov/Press_111/20090526/fsea_draft.pdf"&gt;The Food Safety Enhancement Act of 2009&lt;/a&gt; (note that the acronym for this is FSEA so very close to DSHEA as to be disconcerting) has a title we can all rally around.&amp;nbsp; Reading the summary as presented also makes it sound good.&amp;nbsp; Well, that’s the intent – to make it all sound good.&amp;nbsp; A little closer look reveals a different agenda among the twists and turns.&amp;nbsp; That agenda includes (and this should come as no surprise to those who watch this sort of thing) introducing additional means of getting after that miscreant industry – the Dietary Supplement Industry.&amp;nbsp; There will be more in-depth discussion of this as it moves along the congressional trail but the sponsorship of the bill and the climate tends to indicate that this one has a good likelihood of getting somewhere.&amp;nbsp; Let’s just look at some of the cursory concerns the Natural Products industry should note and act on first.&amp;nbsp; These bits are lifted from the &lt;a href="http://energycommerce.house.gov/Press_111/20090526/fsea_summary.pdf"&gt;Summary of the Draft Legislation&lt;/a&gt;.&lt;br&gt;&lt;br&gt;&lt;b&gt;Facilities Registration:&lt;/b&gt;&amp;nbsp; No big deal.&amp;nbsp; This proposal is different in that all facilities foreign and domestic are required to register ANNUALLY.&amp;nbsp; This allows for the payment of fees &lt;i&gt;&lt;b&gt;ANNUALLY&lt;/b&gt;&lt;/i&gt; in order to continue to do business.&amp;nbsp; Still no big deal but there is a requirement for a US agent as primary contact point for the foreign manufacturers.&amp;nbsp; There are ramifications here for that agent if you understand some of the “exporters goods coming to this country.&amp;nbsp; Still, so far seemingly harmless.&amp;nbsp; Unless you look a little closer still.&amp;nbsp; Using materials from a company that is not registered or whose registration has lapsed renders the products that use this material as Adulterated.&amp;nbsp; This would then likely cancel the registration of your facility and everything you made would then become adulterated if it entered the marketplace.&amp;nbsp; Oh yeah – if your facility is suddenly removed from the approved list you have an “informal hearing” setting in which to appeal. &amp;nbsp;&lt;br&gt;&lt;br&gt;&lt;b&gt;Identifies food safety problems before they occur&lt;/b&gt;:&amp;nbsp; Sounds great.&amp;nbsp; An ounce of prevention and all of that.&amp;nbsp; Well if you look a little closer at the text of the proposed legislation you find the implementation via law of a &lt;i&gt;&lt;b&gt;HACCP&lt;/b&gt;&lt;/i&gt; program for all foods.&amp;nbsp; The evaluation of critical control points in the manufacturing operation will need to be identified and these requirements will apply to foreign manufacturers as well. You will have the burden of assuring these foreign manufacturers meet the standards set up.&lt;br&gt;Increased Inspection Frequency:&amp;nbsp; The revenues generated from the user fees will be used in part to step up inspection of manufacturing facilities.&amp;nbsp; Have you organized your GMP strategies yet?&amp;nbsp; You might wish to.&amp;nbsp; There is also a tiering of classifications of manufacturers from “low risk” to “high risk.”&amp;nbsp;&amp;nbsp; Wonder where the Natural Products facilities will fall.&lt;br&gt;&lt;br&gt;&lt;b&gt;Prevention of Food Safety Problems&lt;/b&gt;:&amp;nbsp; Who can argue with this?&amp;nbsp; Well a little closer look at the draft legislation reveals that there are some interesting definitions that get incorporated in the &lt;i&gt;Federal Food, Drug and Cosmetic Act &lt;/i&gt;that were not there before.&amp;nbsp; It seems that this legislations is crafted to put a tremendous amount of regulatory detail into legislative presentation.&amp;nbsp; Including the subsetting of the importance of adherence to GMPs to a secondary level.&amp;nbsp; &lt;b&gt;Complying with GMPs becomes secondary&lt;/b&gt; to the overall term “Preventive Controls.”&amp;nbsp; It is these Preventive Controls that will become the standard for compliance with GMPs being a mere subset along with “Sanitation”, “Employee training,” “an allergen control program”, “verification procedures” and the dreaded “Other procedures, practices, and processes that the Secretary may deem appropriate . . .”&amp;nbsp; Hmmm – anyone reading this like the sound of this?&lt;br&gt;&lt;br&gt;There are some other troubling aspects of this proposed legislation that jump off the page at first reading.&amp;nbsp; It is well-crafted for what it appears to be intended to do – allow FDA a far greater degree of control over the food industry (including dietary supplement manufacturing) than has ever been in place before. &amp;nbsp;&lt;br&gt;&lt;br&gt;After a first read through of the draft legislation the most troubling language involves the concept of a &lt;b&gt;Food Safety Plan&lt;/b&gt; and its implementation.&amp;nbsp; The requirement is that BEFORE a facility (foreign or domestic) can introduce a food product into interstate commerce, there must be a Food Safety Plan in place.&amp;nbsp; There are numerous details contained in the legislation concerning what this plan must be and some of those details are redundant to a specific class of foods – namely dietary supplements.&amp;nbsp; Most of the requirements are already spelled out in FDA regulations known as GMPs.&amp;nbsp; So, what’s the beef?&amp;nbsp; Well simply put:&amp;nbsp; Legislation has no business being as finely detailed as this piece of legislation is.&amp;nbsp; If there are challenges with the regulations in place, specifically for GMPs, then Congress should pressure FDA to write appropriate regulations.&amp;nbsp; Oh yeah, I almost forgot – FDA did exactly that with the issuance of &lt;i&gt;21 CFR Section 111&lt;/i&gt; for dietary supplements.&amp;nbsp; Therefore we should be fine.&amp;nbsp; Well, the problem is that dietary supplements remain a class of food and thus come under the auspices of this legislation every bit as much as a bag of Tostitos.&lt;br&gt;&lt;br&gt;There is a lot more in this draft legislation and you will find more to learn about it here in this blog posting area. &amp;nbsp;&lt;br&gt;What is required?&amp;nbsp; Right now – get aware.&amp;nbsp; Get active.&amp;nbsp; Let your trade associations know you are aware of this draft legislation, want to know what they are going to do about it and ask them what they understand it to mean.&amp;nbsp; Then, read as much about the draft legislation as you can.&amp;nbsp; Learn about the ramifications of it from more than just one source (even if that source is your trade association) and get an opinion.&amp;nbsp; Then pressure your trade associations to act on YOUR behalf and in response to YOUR desires.&amp;nbsp; There is a lot more to this than meets the eye – and now is the time to get involved rather than at the 11th hour.&amp;nbsp; More to come.&lt;br&gt;&lt;br&gt;</content>
		<summary>While the industry is approaching the preparation for enforcement of the Dietary Supplement GMPs with its usual 11th hour strategy of action just before the hammer falls – another happenstance has surfaced. This one could have some significance and could be the death knell for a portion of DSHEA if not the whole of it. ...</summary>
	</entry>
	<entry>
		<title>One Last Poke in the Eye from FDA Acting Commissioner Sundlof</title>
		<link rel="alternate" href="http://blog.ingredientidentity.com/2009/05/19/one-last-poke-in-the-eye-from-fda-acting-commissioner-sundlof.aspx?ref=rss" />
		<id>tag:blog.ingredientidentity.com,2009-05-19:7f9642cc-38fa-4a59-aefc-520e6f601fc3</id>
		<author>
			<name>Jim Lassiter</name>
			<email>fierceshade@yahoo.com</email>
		</author>
		<category term="FDA and You" />
		<category term="FDA Actions" />
		<category term="Adverse Event Reporting" />
		<updated>2009-05-19T18:48:00Z</updated>
		<published>2009-05-19T18:48:00Z</published>
		<content type="html">The Acting FDA Commissioner issued a statement concerning particularly the unfortunate situation with &lt;b&gt;Hydroxycut&lt;/b&gt; products.&amp;nbsp; Dr. Steven F. Sundlof (yes another Veterinarian running the FDA) made some very solid points in his presentation.&amp;nbsp; Sadly he made some other points that are worth noting and should make us glad that perhaps the next commissioner (the one without the ACTING in front of the title) is soon to come into permanence.&amp;nbsp; Still, as parting shots go, this one from the Acting Dr. Sundlof had its moments&lt;br&gt;&lt;br&gt;Let’s review the &lt;b&gt;Good News first&lt;/b&gt;.&amp;nbsp; The Good News is the tone taken in the overall message.&amp;nbsp; It is one of &lt;b&gt;reassurance&lt;/b&gt; and one that should put the consumer’s mind at ease.&lt;br&gt;&lt;br&gt;“&lt;i&gt;FDA issued a public warning and the company recalled these products because some of the products were associated with a number of serious liver injuries.&lt;/i&gt;”&amp;nbsp; &lt;br&gt;&lt;br&gt;Read that excerpt carefully.&amp;nbsp; &lt;b&gt;FDA issued a&lt;/b&gt; &lt;b&gt;warning&lt;/b&gt; – all that they could legally do within the confines of the law but they issued it promptly.&amp;nbsp; It was the &lt;b&gt;industry&lt;/b&gt; member (the manufacturer) who &lt;b&gt;recalled the products&lt;/b&gt; – not FDA.&amp;nbsp; FDA’s role in protecting the public health was minimal.&amp;nbsp; The company performed the recall in an effort to demonstrate responsible action.&amp;nbsp; There should not be rounds of applause for this without knowing what the manufacturer knew of the potential for harm its supplements were capable of.&amp;nbsp; &lt;br&gt;&lt;br&gt;“&lt;i&gt;FDA received 23 reports of serious health problems . . .&lt;/i&gt;” &lt;br&gt;&lt;br&gt;First of all the reason FDA received these reports is due in large measure to the Dietary Supplement industry prompting Congress to act and require the establishment of an Adverse Event Reporting System for all manufacturers of Dietary Supplements.&amp;nbsp; Second. these reports obviously pointed at several Hydroxycut branded products.&amp;nbsp; The “associated with” aspect of the initial quote is sketchy.&amp;nbsp; What was the degree of association?&amp;nbsp; Was there a direct link between consumption of the product and the adverse events?&amp;nbsp; The actions thus far would indicate this since the manufacturer recalled the product without argument.&amp;nbsp; The BIGGEST issue is &lt;b&gt;whether the manufacturer had awareness&lt;/b&gt; of the problem in advance.&amp;nbsp; This will likely be discovered going forward.&amp;nbsp; This awareness or lack thereof regarding the products sold should raise an eyebrow or two above the eye just poked here from among those of us in the industry using the same ingredients or very similar combinations.&amp;nbsp; Since multiple formulas were involved one must look to see&lt;b&gt; what the common ingredients&lt;/b&gt; and combinations of ingredients were before we can firmly commit to what &lt;b&gt;may have caused the adverse events&lt;/b&gt;.&amp;nbsp; Then you should ask yourselves the question as to whether your products bear too much similarity to the products recalled.&amp;nbsp; If so, what are you prepared to do about it?&lt;br&gt;&lt;br&gt;Now let’s give a good poke in the eye to the outgoing Acting Commissioner as well.&amp;nbsp; You see aside from taking credit where only some credit was due, Dr. Sundlof also took the opportunity to &lt;b&gt;cast a little misrepresentation&lt;/b&gt; and disingenuousness at the Dietary Supplement Industry once more.&amp;nbsp; Dr. Sundlof saw fit to remark:&lt;br&gt;&lt;br&gt;“&lt;i&gt;As a dietary supplement, Hydroxycut is regulated differently than either prescription or over the counter drugs, whether prescription or over-the-counter.&lt;/i&gt;” [sic]&lt;br&gt;&lt;br&gt;This little bit of redundant presentation is accurate.&amp;nbsp; However Hydroxycut and all other &lt;b&gt;Dietary Supplements ARE regulated&lt;/b&gt;.&amp;nbsp; Going on about the apparently lamentable situation Dr. Sundlof drifts into &lt;b&gt;classic DSHEA bashing&lt;/b&gt;:&lt;br&gt;&lt;br&gt;“&lt;i&gt;Under the 1994 Dietary Supplement Health and Education Act, dietary supplement manufacturers do not need to register their products with the FDA nor obtain FDA approval before producing or selling dietary supplements.&lt;/i&gt;”&lt;br&gt;&lt;br&gt;This is only &lt;b&gt;a slight twisting of the truth&lt;/b&gt;.&amp;nbsp; DSHEA did nothing to either remove registration requirements or to mention such registration.&amp;nbsp; These products have NEVER been required to be registered.&amp;nbsp; Still. Dr. Sundlof decided to point the finger (or should I say paw) of blame at DSHEA for this situation.&amp;nbsp; DSHEA had nothing to do with the current and historic state of affairs.&amp;nbsp; &lt;b&gt;Dietary Supplements are a class of FOOD&lt;/b&gt; and thus not subject to registration, as are DRUGS as Dr. Sundlof implies.&amp;nbsp; DSHEA did not create the situation, it is responsible for a lot of things that have gone awry within the industry but lack of registration of products is not one of them.&lt;br&gt;Dr. Sundlof is not finished though.&amp;nbsp; One more bash before he returns to his hoof and horn practice:&lt;br&gt;&lt;br&gt;“&lt;i&gt;The FDA has taken other recent actions to help protect the safety of consumers of products marketed as dietary supplements. This March, the FDA issued a nationwide alert about more than 70 tainted weight loss products containing undeclared, active pharmaceutical ingredients - including prescription-only drugs&lt;/i&gt;.”&lt;br&gt;&lt;br&gt;This again is a true statement.&amp;nbsp; At least up to the point where the products are identified.&amp;nbsp; &lt;b&gt;The weight-loss products identified were not, by legal and regulatory definition, Dietary Supplements&lt;/b&gt; specifically because they contained “active pharmaceutical agents.”&amp;nbsp; This renders these products DRUGS that are being marketed as Dietary Supplements.&amp;nbsp; &lt;b&gt;The challenge is&lt;/b&gt; less in the fact that Dietary Supplements are not regulated as drugs but more in the fact &lt;b&gt;that Drugs are being&lt;/b&gt; included in and &lt;b&gt;misrepresented as Dietary Supplements&lt;/b&gt;.&amp;nbsp; The enforcement actions taken were applauded by the Dietary Supplement industry while not a whisper is heard from the pharmaceutical industry – perhaps because of the loss of business from these miscreants.&lt;br&gt;&lt;br&gt;The last point of note from the good Dr. Sundlof is a slightly altered echo from the Dietary Supplement industry itself:&lt;br&gt;&lt;br&gt;“ . . . &lt;i&gt;FDA suggests that you consult with a health care professional before using any dietary supplement because many supplements contain ingredients that have strong biological effects &lt;/i&gt;. . .”&lt;br&gt;&lt;br&gt;&lt;b&gt;The Dietary Supplement industry as long advocated discussing with your health care provider your consumption of dietary supplements&lt;/b&gt; of all sorts. The challenges have been in the receptivity of the physicians owing to their lack of knowledge and the misinformation handed to them by, among others, FDA.&amp;nbsp; The second part of this last statement is very interesting.&amp;nbsp; &lt;b&gt;FDA has historically denied any activity on the part of dietary ingredients and dietary supplements.&lt;/b&gt;&amp;nbsp; They deny any benefit and thus, in risk/benefit analysis, which is the direction FDA wants to take the discussion, there being no benefit, ANY risk eliminates the dietary ingredient.&amp;nbsp; While stopping short of saying that dietary ingredients and dietary supplements provide benefit, at least there is acknowledgement that there is “biological effect.”&amp;nbsp; I’ll take that stance even if it is from an interim voice.&amp;nbsp; Sadly, Dr. Sundlof is not finished with the topic as the sentence concludes:&lt;br&gt;&lt;br&gt;“ . . . &lt;i&gt;and such products may not be safe for all people&lt;/i&gt;.”&lt;br&gt;&lt;br&gt;&lt;b&gt;The evaluation of safety was presented in DSHEA itself, &lt;/b&gt;ironically the amendment to the Federal Food, Drug and Cosmetic Act that Dr. Sundlof has such issue with.&amp;nbsp; Congress found:&lt;br&gt;&lt;br&gt;“ . . &lt;i&gt;&lt;b&gt;.dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare&lt;/b&gt;&lt;/i&gt; . . .”&lt;br&gt;&lt;br&gt;FDA has not acquiesced as yet to these findings in spite of their mandate to do so as an arm of the government, not as lawmakers.&amp;nbsp; With the imminent retirement of Dr. Sundlof to some other level of the bureaucracy, perhaps a more reasoned voice will emerge.&amp;nbsp; Perhaps as well our industry will recognize the importance of understanding the ingredients we use to the fullest extent possible and not perform as the pharmaceutical industry has and sweep the bad news under the rug and rely on FDA to act.&amp;nbsp; We shall see.&lt;br&gt;&lt;br&gt;</content>
	</entry>
	<entry>
		<title>Suppliers and Ingredient Identity Testing</title>
		<link rel="alternate" href="http://blog.ingredientidentity.com/2009/05/18/ingredient-identity-testing.aspx?ref=rss" />
		<id>tag:blog.ingredientidentity.com,2009-05-18:f59456eb-b92d-4458-b4cc-a54171061d33</id>
		<author>
			<name>Jim Lassiter</name>
			<email>fierceshade@yahoo.com</email>
		</author>
		<category term="Regulatory Need to Know's" />
		<updated>2009-05-18T18:04:00Z</updated>
		<published>2009-05-18T18:04:00Z</published>
		<content type="html">There are some very good reasons behind the importance of Ingredient Identity.&amp;nbsp; Most of these are obvious.&amp;nbsp; However, there are a couple of reasons that are less obvious and that are rooted deep in the implementation of Dietary Supplement GMPs.&amp;nbsp; These reasons fall to both the purchaser of the ingredient and a little more surprisingly to the supplier of the ingredient.&amp;nbsp; Looking at it from both perspectives the reasons are very clear.&lt;br&gt;For the purchaser of the ingredient, the Dietary Supplement GMPs are very clear.&amp;nbsp; The Final Rule requires manufacturers of Dietary Supplements to establish specifications for “&lt;b&gt;identity&lt;/b&gt;, purity, strength and composition” of the ingredients used (empohasis added).&amp;nbsp; You as a manufacturer as required to do this.&amp;nbsp; The supplier of the ingredient is not so required.&amp;nbsp; Recall that in the transition from Proposed Rule to Final Rule the onus of regulations fell off of the manufacturers of dietary ingredients and shifted exclusively to the manufacturers of Dietary Supplements.&amp;nbsp; Also, the Final Rule also allows for the use of a Certificate of Analysis for assuring the identity of components.&amp;nbsp; But you must read the fine print.&lt;br&gt;As a manufacturer of a Dietary Supplement you must “&lt;b&gt;Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient . . .&lt;/b&gt;” You see the Certificate of Analysis provision applies to components other than dietary ingredients.&amp;nbsp; Well, how are you going to test?&amp;nbsp; These answers point straight back to the supplier of the dietary ingredient.&amp;nbsp; The supplier of the dietary ingredient is nearly always the contact point but not always the manufacturer of the ingredient.&lt;br&gt;Thus the onus of how to test for identity of the dietary ingredient (the test that must be performed by the manufacturer of the Dietary Supplement) is going to come from the supplier of the dietary ingredient whether directly or from someone else further up the supply chain.&lt;br&gt;&lt;b&gt;The supplier of the dietary ingredient, therefore, is not off the hook at all when it comes to Dietary Supplement GMPs&lt;/b&gt;.&amp;nbsp; They are going to be increasingly pressured by their customers (the manufacturers of Dietary Supplements) to establish and share the methods of testing the identity of their product.&amp;nbsp; &lt;br&gt;As time goes on with the full implementation of the Dietary Supplement GMPs it is going to be increasingly more incumbent upon the supplier of the dietary ingredient to insure that they have an appropriate test method to give over to their customers for identity determination.&amp;nbsp; Yes, the Manufacturer is going to be held accountable at inspection time, but rest assured that their reliance is going to shift that burden over to the supplier.&amp;nbsp; &lt;br&gt;The bottom line is that Suppliers and Consumers of dietary ingredients had best become familiar with the GMPs and what the requirements are.&amp;nbsp; The Suppliers especially had best become more familiar in order to keep their business flowing.&amp;nbsp; Stay Tuned.&lt;br&gt;&lt;br&gt;</content>
	</entry>
	<entry>
		<title>GMPs and the NBA</title>
		<link rel="alternate" href="http://blog.ingredientidentity.com/2009/05/14/gmps-and-the-nba.aspx?ref=rss" />
		<id>tag:blog.ingredientidentity.com,2009-05-14:dc750b61-cd16-4719-81df-97b036f79c5d</id>
		<author>
			<name>Jim Lassiter</name>
			<email>fierceshade@yahoo.com</email>
		</author>
		<category term="Regulatory Need to Know's" />
		<updated>2009-05-15T04:13:00Z</updated>
		<published>2009-05-15T04:13:00Z</published>
		<content type="html">Since blogs are supposed to be topical this one fits right in.&amp;nbsp; As I write this we are deep in the midst of the NBA Playoffs.&amp;nbsp; As I was reviewing some of the action and the outcomes a thought struck me concerning the similarity between the NBA and the Dietary Supplement Industry.&amp;nbsp; Specifically the new GMPs for Dietary Supplements. Now it may not be immediately obvious but there is a significant similarity that should be noted and perhaps this sports analogy will get the members of the industry aware of what is coming.&lt;br&gt;&lt;br&gt;This June the NBA playoffs will conclude but the full-court coverage of the FDA’s enforcement action on companies manufacturing dietary supplements goes into full effect.&amp;nbsp; While this is a nice segue into the topic it is not the heart of the matter.&amp;nbsp; Here comes the reality when the enforcement actions begin.&amp;nbsp; Let’s look at the NBA for a minute.&amp;nbsp; The game has rules and when those rules are violated, penalties are assessed.&amp;nbsp; This can range from taking the ball out of bounds through free throws through ejections from the game and even additional suspensions and fines.&amp;nbsp; Well, the FDA acts as a referee in determining the “fouls” assessed individual companies when they are inspected for GMP compliance.&amp;nbsp; These fouls can be an issuance of a report listing the deficiencies all the way to closing the doors of your operation and assessing heavy fines.&amp;nbsp; Sure a bit of an analogous stretch but here is where the real similarity exists.&lt;br&gt;&lt;br&gt;In the NBA one of the most controversial aspects of the referee’s job during these playoffs has been the assessment of “flagrant fouls.”&amp;nbsp; There are multiple categories of these flagrant fouls and the assignment of category resides with the referee.&amp;nbsp; The difference in categories is significant relative to whether a key player is ejected or perhaps even suspended.&amp;nbsp; The controversy comes in where the referee has to make these judgments regarding the intentions and actions of the players.&amp;nbsp; When it comes to the GMPs for Dietary Supplements, the same holds true.&amp;nbsp; The FDA issued the Final Rule and touted loudly the “flexibility” you have as a manufacturer to achieve compliance.&amp;nbsp; What is not openly stated in the regulations nor in the preamble to the regulations is the fact that the interpretation of whether you are in compliance is strictly up to the inspector (akin to the referee).&amp;nbsp; The inspector has the authority to assess and make judgments as to the efforts you have made are sufficient to meet the requirements of the regulation.&amp;nbsp; This is the other edge of the sword of flexibility.&amp;nbsp; You may feel confident that you have taken steps to insure that the batch records, for instance, are complete and have the appropriate signatures as well as reflecting the points in the process where control is necessary. The inspector need not see it this way at all.&amp;nbsp; Their interpretation of the regulation is going to likely vary from day to day, inspector to inspector and even company to company.&amp;nbsp; Inspection guidances are forthcoming from FDA for their personnel to assist in this effort but in their absence you are hoping to succeed in compliance rather than being assured if you don’t take the extra steps necessary.&amp;nbsp; Then when the Guidance Documents come out – will you know about them.&lt;br&gt;&lt;br&gt;The Dietary Supplement GMPs are intended to be of great benefit to the consumer in insuring the safety and consistency of the products they buy while further assuring the consumer that they are getting what they are paying for.&amp;nbsp; The implementation of this regulation though means that you have some work to do and June is just around the corner.&amp;nbsp; Before you are cited for a “flagrant foul” and have to pay a price far greater than a free throw – seek professional help.&amp;nbsp; The resources are out there and you should insure that the interpretation is kept to a minimum.&lt;br&gt;&lt;br&gt;JL &lt;br&gt;&lt;br&gt;&lt;br&gt;Ingredient Identity - www.ingredientidentity.com&lt;br&gt;</content>
	</entry>
	<entry>
		<title>Welcome</title>
		<link rel="alternate" href="http://blog.ingredientidentity.com/2009/04/20/welcome.aspx?ref=rss" />
		<id>tag:blog.ingredientidentity.com,2009-04-19:6295e13f-7889-46fb-a59a-5abbd8f961c5</id>
		<author>
			<name>Jim Lassiter</name>
			<email>fierceshade@yahoo.com</email>
		</author>
		<category term="Regulatory Need to Know's" />
		<updated>2009-04-20T02:14:29Z</updated>
		<published>2009-04-20T02:14:29Z</published>
		<content type="html">Welcome to the Ingredient Identity Blog. Please check in for new entries or connect with the LIVE CHAT!&lt;br&gt;&lt;br&gt;JL&lt;br&gt;&lt;br&gt;&lt;br&gt;Ingredient Identity - &lt;a href="http://www.ingredientidentity.com&lt;br&gt;&lt;br&gt;&lt;br&gt;&lt;br&gt;&lt;center&gt;&lt;a"&gt;www.ingredientidentity.com&lt;br&gt;&lt;br&gt;&lt;br&gt;&lt;br&gt;&lt;center&gt;&lt;a&lt;/a&gt; href="http://www.ineedhits.com/free-tools/submit-free.aspx?source=FTSFbutton"&gt;&lt;img src="http://www.ineedhits.com/images/trackingbuttons/SFbutton.gif?ref=14293" border="0" height="32" width="90" alt="ineedhits!"&gt;&lt;/a&gt;&lt;/center&gt;</content>
	</entry>
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