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	<title>USDA &#8211; FDA Compliance Made Easy</title>
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	<title>USDA &#8211; FDA Compliance Made Easy</title>
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		<title>USDA Organic Labeling</title>
		<link>https://giannamore-law.com/usda-organic-labeling/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=usda-organic-labeling</link>
		
		<dc:creator><![CDATA[]]></dc:creator>
		<pubDate>Thu, 13 Nov 2014 19:58:28 +0000</pubDate>
				<category><![CDATA[USDA]]></category>
		<category><![CDATA[Labeling]]></category>
		<category><![CDATA[National Organic Program]]></category>
		<category><![CDATA[NOP]]></category>
		<category><![CDATA[organic]]></category>
		<guid isPermaLink="false">http://www.giannamore-law.com/?p=1254</guid>

					<description><![CDATA[The United States Department of Agriculture (USDA) oversees the National Organic Program and organic labeling in the United States. The National Organic Program is a regulatory program housed within USDA Agricultural Marketing Service, which sets standards for organically produced agricultural &#8230; ]]></description>
										<content:encoded><![CDATA[<p>The United States Department of Agriculture (USDA) oversees the <a href="http://www.ams.usda.gov/AMSv1.0/nop">National Organic Program</a> and organic labeling in the United States. The National Organic Program is a regulatory program housed within USDA Agricultural Marketing Service, which sets standards for organically produced agricultural products. These standards do not address food safety or nutrition, as these issues are within the regulatory oversight of FDA or other USDA programs. The statutes under which the National Organic Program operates are found <a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=9fa9aff0dbcc451177c974bf3efe0d18&amp;node=pt7.3.205&amp;rgn=div5#sp7.3.205.d">here</a>.</p>
<p>When a company wants to use organic labeling or label a product in a way that promotes the use of to organic ingredients, they may use the phrase, “made with organic ____” in labeling if the product meets the requirements set out in the statutes. First, the USDA must <a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=ec503ce86a22659632f2bb323d5db3cd&amp;node=7:3.1.1.9.32.2.354.1&amp;rgn=div8">certify</a> operations that grow, handle, or process organic products as organic. In other words, the producer of the organic material must be certified as “organic” by the USDA. <a href="http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&amp;SID=6545f3e932fdfd8b41a5f84081c591ad&amp;n=pt7.3.205&amp;r=PART&amp;ty=HTML#sp7.3.205.a">Subpart E</a> of the National Organic Program governs organic certification.</p>
<p>Foods that are labeled with the “Made with organic” language must comply with strict requirements. First, they contain at least 70% organic ingredients, <a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=9fa9aff0dbcc451177c974bf3efe0d18&amp;node=pt7.3.205&amp;rgn=div5#sp7.3.205.d">7 CFR</a> <a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=9fa9aff0dbcc451177c974bf3efe0d18&amp;node=pt7.3.205&amp;rgn=div5#sp7.3.205.d">§ 205.301(c)</a>. As opposed to organic labeled foods, this means that a “Made with organic ____” product may contain a maximum of 30% nonorganic ingredients, as set forth in the National List of Allowed and Prohibited Products, codified at <a href="http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&amp;SID=6545f3e932fdfd8b41a5f84081c591ad&amp;n=pt7.3.205&amp;r=PART&amp;ty=HTML#se7.3.205_1605">7 CFR § 205.605</a>.  Further, these types of products must not contain any ingredient made using any of the prohibited methods as listed in <a href="http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&amp;SID=6545f3e932fdfd8b41a5f84081c591ad&amp;n=pt7.3.205&amp;r=PART&amp;ty=HTML#se7.3.205_1105">7 CFR § 205.105</a>.</p>
<p>Products are only allowed to list three (3) ingredients, food groups, or combination of ingredients and food groups after the “Made with organic ____” statement. A generic “Made with organic ingredients” statement is prohibited. There are also many other restrictions on the types of labeling allowed with organic ingredients. For example, when a product uses organic and inorganic versions of the same ingredient, the ingredients must be listed separately on the ingredients list. Further, specific ingredients cannot have their own “percent organic” label. A label that includes “100% organic sugar” is in violation of the National Organic Program. For more examples of prohibited labels and how to fix labeling problems, the USDA has produced a <a href="http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5107319">guidance document</a>, or explanatory document setting forth the Agency’s current policy on the topic.</p>
<p>If a company wants to include a food group-specific label claim on their “Made with organic” statement, the only food groups that can be listed are beans, fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, sweeteners, vegetables, or processed milk. All other food groups are prohibited to be listed as “Made with organic” as described in <a href="http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&amp;SID=d0606f1560066aa6ba01d61a81ee7180&amp;rgn=div8&amp;view=text&amp;node=7:3.1.1.9.32.4.354.5&amp;idno=7">7 CFR § 205.304</a>. In addition, these label claims must be truthful. As with other ingredients, if it is going to be included as a “Made with organic” ingredient, all raw and processed forms of that ingredient must be certified organic.</p>
<p>The world of organic labeling is ever-changing and has very specific requirements. Labeling your product is a very complex task and doing so incorrectly can result in penalties ranging from <a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=9fa9aff0dbcc451177c974bf3efe0d18&amp;node=pt7.3.205&amp;rgn=div5#sg7.3.205_1643_6205_1649.sg3">suspension to rejection</a> of the company’s organic status. Knowingly selling a product labeled as organic or with some form of organic labeling that does not comply with the organic labeling regulations can result in fines of up to <a href="http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateE&amp;navID=CompEnforceLinkNOPAboutUs&amp;rightNav1=CompEnforceLinkNOPAboutUs&amp;topNav=&amp;leftNav=NationalOrganicProgram&amp;page=NOPComplianceandEnforcement&amp;resultType=&amp;acct=nopgeninfo">$11,000 per violation</a>. For questions regarding organic labeling and for inquiries about <a href="http://giannamore-law.com/our-services/label-reviews/">label reviews</a> of your product labels, please contact us at <a href="mailto:contact@sglawfl.com">contact@sglawfl.com</a>.</p>
<p><a href="http://www.giannamore-law.com/wp-content/uploads/2014/11/FDA-Attorney.png"><img decoding="async" class="alignright  wp-image-1257" alt="organic labeling" src="http://www.giannamore-law.com/wp-content/uploads/2014/11/FDA-Attorney-150x150.png" width="54" height="54" /></a></p>
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		<title>FDA Announces Recall of Alfalfa Sprouts After Listeria Monocytogenes is Detected</title>
		<link>https://giannamore-law.com/fda-announces-recall-of-alfalfa-sprouts-after-listeria-monocytogenes-is-detected/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=fda-announces-recall-of-alfalfa-sprouts-after-listeria-monocytogenes-is-detected</link>
		
		<dc:creator><![CDATA[]]></dc:creator>
		<pubDate>Tue, 08 May 2012 20:03:09 +0000</pubDate>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[USDA]]></category>
		<category><![CDATA[Food]]></category>
		<category><![CDATA[Listeria]]></category>
		<category><![CDATA[Recalls]]></category>
		<guid isPermaLink="false">http://giannamore-law.com/?p=153</guid>

					<description><![CDATA[On May 8, 2012, the U.S. Food and Drug Administration (“FDA”) announced the recall of alfalfa sprouts produced by the company Cleveland Beansprouts Co. Discussed here, the Company is recalling the sprouts due to the possible contamination with Listeria monocytogenes. &#8230; ]]></description>
										<content:encoded><![CDATA[<p style="text-align: justify;">On May 8, 2012, the U.S. Food and Drug Administration (“FDA”) announced the recall of alfalfa sprouts produced by the company Cleveland Beansprouts Co. Discussed <a href="http://www.fda.gov/Safety/Recalls/ucm303305.htm?source=govdelivery">here</a>, the Company is recalling the sprouts due to the possible contamination with <em>Listeria monocytogenes</em>. For more information about <em>Listeria monocytogenes</em>, please see our previous post <a href="http://giannamore-law.com/?p=58">here</a>.</p>
<p style="text-align: justify;">Through the U.S. Department of Agriculture’s (“USDA”) Microbiological Data Program (“MDP”), state agencies cooperate with the federal government in collecting and analyzing data to protect consumers from the spread of food-borne pathogens. The sprouts, which were only distributed in Ohio and never crossed state lines, were found to be contaminated with the bacteria after microbiological testing (a part of the MDP) was conducted by the Ohio Department of Agriculture. Thus, this recent recall illustrates not only how the various federal agencies work together, but how federal and state regulatory authorities exercise power jointly in preventing outbreaks. More information about the USDA&#8217;s MDP may be accessed <a href="http://www.ams.usda.gov/AMSv1.0/mdp">here</a>.</p>
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		<title>FDA Issues Statement on USDA BSE (“mad-cow”) Case</title>
		<link>https://giannamore-law.com/fda-issues-statement-on-usda-bse-mad-cow-case/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=fda-issues-statement-on-usda-bse-mad-cow-case</link>
		
		<dc:creator><![CDATA[]]></dc:creator>
		<pubDate>Fri, 27 Apr 2012 16:50:40 +0000</pubDate>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[USDA]]></category>
		<category><![CDATA[mad cow]]></category>
		<guid isPermaLink="false">http://giannamore-law.com/?p=113</guid>

					<description><![CDATA[On April 26, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the recent announcement confirming a case of bovine spongiform encephalopathy (“BSE”). The U.S. Department of Agriculture’s (“USDA”) announcement confirming and explaining this case may be &#8230; ]]></description>
										<content:encoded><![CDATA[<p style="text-align: justify;">On April 26, 2012, the U.S. Food and Drug Administration (“FDA”) issued a <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm301850.htm">statement</a> concerning the recent announcement confirming a case of bovine spongiform encephalopathy (“BSE”). The U.S. Department of Agriculture’s (“USDA”) announcement confirming and explaining this case may be accessed <a href="http://www.youtube.com/watch?v=o_cH3kyyeAI&amp;feature=youtu.be">here</a>. According to the USDA, the particular cow involved was a dairy cow, and thus never had contact with any animals intended to enter the nation&#8217;s food supply.</p>
<p style="text-align: justify;">BSE, more commonly known as “mad-cow disease” is a deadly neurological disease in cattle that causes degeneration in the brain and spinal cord. The disease may be spread from diseased cattle to humans through the consumption of food contaminated by infected animals. Thus, it is critical that the federal government closely monitors the nation’s food supply to thwart the spread of this disease. According to the USDA, the recent BSE case is an isolated incident and involved an animal that never entered the food supply. Accordingly, the USDA notes that there is no threat for individuals consuming beef. More information about the BSE outbreak may be accessed <a href="http://usda.gov/wps/portal/usda/usdahome?navtype=SU&amp;navid=BSE">here</a>.</p>
<p style="text-align: justify;">While the USDA oversees agricultural products, including cattle, to ensure that the nation’s food supply is safe for human consumption. In addition, the FDA is responsible for ensuring that those products not specifically covered by USDA regulations are safe for consumers, including other foods and dietary supplement products, many containing components of beef. Thus, the jurisdiction of the USDA and FDA has some overlap. While the current mad-cow case is within the primary responsibility of the USDA, the FDA’s statement highlights the cooperation between the federal agencies.</p>
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