NMR News: Volume 3, Issue 1, January 2010


                              MARKETING OPINION BLOG

CONSIDERING THE SCIENTIF...
NMR News: Volume 3, Issue 1, January 2010




Scientific Reasoning of FDA’s “current thinking”


Let’s take a look at an e...
NMR News: Volume 3, Issue 1, January 2010


additive” and “GRAS,” according to the FDA’s definition. A substance that has ...
NMR News: Volume 3, Issue 1, January 2010


September 2009 which details some basic scientific truths. It discusses how a ...
NMR News: Volume 3, Issue 1, January 2010


excess of their traditional use levels or in new beverages or other convention...
NMR News: Volume 3, Issue 1, January 2010


unapproved food additive. The reason is that if you change the condition of us...
NMR News: Volume 3, Issue 1, January 2010




       To many people’s disliking, the FDA, in issuing this guidance, is exe...
NMR News: Volume 3, Issue 1, January 2010


For a complete list of GRAS substances that were evaluated by the Select Commi...
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FDA Guidance On Liquid Dietary Supplements Vs. Beverages Commentary Jan 2010 News

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Considering the Scientific Reasoning for FDA\'s Guidance on Factors that Distinguish Liquid Dietary Supplements from Beverages

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FDA Guidance On Liquid Dietary Supplements Vs. Beverages Commentary Jan 2010 News

  1. 1. NMR News: Volume 3, Issue 1, January 2010 MARKETING OPINION BLOG CONSIDERING THE SCIENTIFIC REASONING FOR FDA’S GUIDANCE ON FACTORS THAT DISTINGUISH LIQUID DIETARY SUPPLEMENTS FROM BEVERAGES By: Latesha Richards, Marketing Coordinator By now most, if not all, of you may have read the new FDA guidance published in December 2009 regarding the factors that distinguish liquid dietary supplements from beverages. As manufacturers and/or marketers of these products, some of you may be frustrated at yet another hurdle the FDA presents to the successful marketing of dietary supplements. Some of you may be greatly concerned about the extent to which the “new” FDA is exercising their regulatory authority over a relatively “free” natural products market. A few of you may find the guidance’s reasoning hard to grasp. There are some arguments that one could make about the FDA’s reasoning. One could argue that this is a result of the politics of too much government. Another could argue that the federal government wants to remain consistent in their measures and ability to keep the public safe, everything from international threats to domestic foods and dietary supplements. But after having read the guidance and understanding the FDA’s concerns, the reasoning for such guidance comes from a fundamental understanding of scientific principles. In this article, we will attempt to rationalize the technical aspect of the guidance with such scientific principles. 1
  2. 2. NMR News: Volume 3, Issue 1, January 2010 Scientific Reasoning of FDA’s “current thinking” Let’s take a look at an excerpt from the guidance that is up for discussion in this article: …FDA has seen a growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts. Some of these ingredients have not previously been used in conventional foods and may be unapproved food additives. In addition, ingredients that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels or in new beverages or other conventional foods. This trend raises questions regarding whether these ingredients are unapproved food additives when used at higher levels or under other new conditions of use. Some foods with novel ingredients also bear claims that misbrand the product or otherwise violate the FFDCA.1 The FDA makes clear in this passage that their concern with the marketing of beverages and conventional foods involves the new trend of adding ingredients that have not been approved for their intended use, such as adding novel botanical extracts that have not been approved as food additives OR adding higher concentrations of ingredients that have not been approved as “Generally Recognized as Safe” (GRAS). Let’s analyze the two (2) main points made here and attempt to rationalize them from a scientific point of view. FDA Point #1: “Some of these [novel] ingredients have not previously been used in conventional foods and may be unapproved food additives.” Here the FDA mentions both “unapproved food additives” and ingredients that “have not been previously used in conventional foods” or what is called “non-GRAS approved” substances. Before delving into their statement, it is necessary for us to define the terms “food 2
  3. 3. NMR News: Volume 3, Issue 1, January 2010 additive” and “GRAS,” according to the FDA’s definition. A substance that has been approved as GRAS, is a substance commonly used in foods over many years that has been generally recognized as safe by qualified experts under the intended conditions of use AND has been shown to be safe by available scientific evidence. GRAS substances do not require pre-market approval. A food additive is any substance that has not been commonly used in conventional foods that “requires pre-market approval based on [scientific] data demonstrating safety…” for the intended use in a food.1 Both GRAS substances and food additives require the same quantity and quality of scientific evidence. Novel ingredients, as the FDA suggests, are ingredients that may be botanical or herbal in nature, that have neither been approved as GRAS substances nor as approved food additives. When used in dietary supplements, novel ingredients do not need to be GRAS approved or do not require pre-market approval by the FDA, but the FDA does expect that such ingredients do not pose a significant or unreasonable risk of harm. Conversely, novel ingredients in beverages or conventional foods, in fact, must be approved as GRAS or food additives before use. According to the FDA, these ingredients have not been approved and they find this a major concern. Why? If you’ve been following NMR over the course of 2009, specifically over the past several months, you may have come across our article piece entitled "Proprietary Research - Bringing Nutraceuticals to the Next Level: Conducting product- or ingredient- specific research is crucial to the long term success of this market" published in Nutraceuticals World in 3
  4. 4. NMR News: Volume 3, Issue 1, January 2010 September 2009 which details some basic scientific truths. It discusses how a change to a substance will often produce distinct pharmacokinetic and pharmacological profiles and behaviors that may compromise safety. The same principle applies here. Novel ingredients, by definition, have not yet been shown to be safe by scientific evidence for their intended purpose. These novel ingredients such as botanicals, herbs, and their extracts or even enhanced single ingredients may come in the form of a combination of ingredients or from a particular type of extraction procedure. In both cases, each event may subject the individual ingredients involved to a chemical alteration of some sort. For example, enhancing single ingredients may involve adding a chemical to it or using a chemical procedure that may alter the properties and effects of the starting ingredient. Herbs and botanical ingredients, which themselves contain a mixture of various components may not be safe in food if it has not been rigorously tested, or different extraction procedures of these herbs or botanicals can result in different concentrations of components. In addition, when multiple ingredients are added together, ingredient interactions may occur and result in an alteration of the safety profile, even when each ingredient is GRAS or has already been considered relatively safe in dietary supplements. Therefore, in order for these beverages or conventional foods to be lawfully marketed, the guidance seems to imply that manufacturers or marketers of novel ingredients obtain either pre-approval as a food additive or approval as GRAS because of their concerns about the safety of the available food supply. FDA Point #2: “In addition, ingredients that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in 4
  5. 5. NMR News: Volume 3, Issue 1, January 2010 excess of their traditional use levels or in new beverages or other conventional foods. This trend raises questions regarding whether these ingredients are unapproved food additives when used at higher levels or under other new conditions of use. ” Here the FDA raises several issues. First, they talk about GRAS substances, although it is not clear if they are specifying substances that may have been or may have not obtained GRAS approval. Second, the FDA raises the issue that these substances are being used in excess of their traditional use. Despite whether these substances are GRAS approved or not, a modification to their concentration levels will, in fact, make the substance a non-GRAS or equivalent to a “novel” ingredient (as discussed above), because the new ingredient is neither GRAS approved nor is it the original form of the substance. Again, the scientific reasoning is this: when ingredients or substances are subjected to an increase in concentration, or if there is a significant increase in consumption by the user, the increase can compromise dietary safety. One must be cautious of making the general assumption that a higher concentration of a GRAS substance will result in increased effectiveness. In fact, it is possible that even a slight increase in concentration can result in an adverse reaction. The FDA argues that such an alteration causes the food additive, or in this case, the GRAS substance, to be adulterated. Let’s analyze the second part of FDA’s statement. A modification to the intended condition of use for a GRAS substance will also make the substance non-GRAS, and thus an 5
  6. 6. NMR News: Volume 3, Issue 1, January 2010 unapproved food additive. The reason is that if you change the condition of use for caffeine from a cola-type beverage to a dietary supplement for example, the caffeine may be subjected to interactions with other ingredients in the supplement that may cause adverse events or the caffeine may behave differently in the new environment. Either way, scientific and clinical research is necessary to prove that caffeine can be safely added under the new conditions. Therefore, according to the FDA, health claims made for these conventional foods are misrepresenting or “misbranding” the product, because the scientific evidence used to substantiate the GRAS status of the original ingredient would not apply to the new ingredient. For example, the GRAS substance caffeine, as evaluated and determined by scientific experts received a 3 and 4 rating for conclusion on safety. Those ratings are as follows: Rating 3: While no evidence in the available information on [substance] demonstrates a hazard to the public when it is used at levels that are now current and in the manner now practiced, uncertainties exist requiring that additional studies be conducted.2 Rating 4: The evidence on [substance] is insufficient to determine that the adverse effects reported are not deleterious to the public health should it be used at former levels and in the manner formerly practiced.2 These conclusions point out that uncertainty still exists with caffeine because more scientific studies are required to determine if the substance is generally safe to use in levels beyond traditional use. While the FDA may be referring to products marketed as energy drinks, where an excess of caffeine is typically added to illicit an “energy boosting” effect, this guidance can refer to any GRAS compound added in excess. 6
  7. 7. NMR News: Volume 3, Issue 1, January 2010 To many people’s disliking, the FDA, in issuing this guidance, is exercising aggressive oversight of the natural products industry in order to keep the supply of foods and beverages safe. They also seem, as the guidance suggests, equally or more concerned about whether or not there is evidence that supports the use of ingredients, whether they have been approved by experts to be safe and/or approved by clinical evidence. Their actions are being done with good intentions. But with all FDA guidance, there are implications for those groups affected: manufacturers and marketers of conventional foods. Those implications are as follows: If your company plans to market or is currently marketing a liquid as a dietary supplement, you must make sure that the packaging, brand name, dietary intakes, serving amounts and label claims are consistent with the FDA’s definition of a dietary supplement or revise them to make them conform to a dietary supplement. Otherwise, if your company plans to market the liquid as a beverage or conventional food using a novel ingredient or a GRAS ingredient in excess of traditional use, you must seek approval for the new ingredient as a food additive and extensive scientific and clinical evidence to support the safety of the new ingredient as a food additive. The company must also make sure that the health claims stated (whether they be qualified health, nutrient-content or structure-function claims) are appropriately and accurately branding the product. 7
  8. 8. NMR News: Volume 3, Issue 1, January 2010 For a complete list of GRAS substances that were evaluated by the Select Committee on GRAS Substances (SCOGS), and their safety ratings, go to: http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=scogsListing For a complete list of FDA-approved food additives, visit: http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=eafusListing NMR is a premier contract research organization exclusively focused on natural product research. NMR is dedicated to educating, building strategic partnerships and performing full clinical research services for natural product companies. For more information, please visit NMR at www.nutraceuticalmedicalresearch.com. Call 914-220-8325 or email us at info@nutraceuticalmedicalresearch.com References 1. Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods. FDA Website. December 2009. Accessed on January 20, 2010. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm 192702.htm 2. GRAS Substances (SCOGS) Database. FDA Website. October 2006. Accessed on January 20, 2010. http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASS ubstancesSCOGSDatabase/default.htm 8

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