FDA Final Guidance Document: “Ingredients Declared as Evaporated Cane Juice”

This is an article taken from the official FDA U.S. Food and Drug Administration website.

I. Introduction

The purpose of this guidance is to enhance consumers’ ability to make informed choices among sweeteners by promoting accurate and consistent labeling. More specifically, this guidance is intended to advise the regulated industry of our view that the term “evaporated cane juice” is not the common or usual name of any type of sweetener and to assist manufacturers in appropriately labeling products that contain sweeteners derived from the fluid extract of sugar cane.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

II. Background

In recent years the term “evaporated cane juice” has appeared as an ingredient on food labels, most commonly to declare the presence of sweeteners derived from the fluid extract of sugar cane.  However, as discussed in detail in section III of this guidance document, FDA’s view is that such sweeteners should not be declared on food labels as “evaporated cane juice” because that term does not accurately describe the basic nature of the food and its characterizing properties (i.e., that the ingredients are sugars or syrups) (Refs. 1, 2, 3).  Moreover, the use of “juice” in the name of a product that is essentially sugar is confusingly similar to the more common use of the term “juice” — “the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree” (21 CFR 120.1(a)).  Thus, the term “evaporated cane juice” is false or misleading because it suggests that the sweetener is “juice” or is made from “juice” and does not reveal that its basic nature and characterizing properties are those of a sugar.

As provided in 21 CFR 101.4(a)(1), “Ingredients required to be declared on the label or labeling of a food . . . shall be listed by common or usual name . . . .”  The common or usual name for an ingredient is the name established by common usage or by regulation (21 CFR 102.5(d)).  Each class or subclass of food is to be given a common or usual name that states, in clear terms, what it is in a way that distinguishes it from different foods.  The common or usual name, which may be a coined term, must accurately describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients; must be uniform among all identical or similar products; and may not be “confusingly similar to the name of any other food that is not reasonably encompassed within the same name” (21 CFR 102.5(a)).

Sugar cane products exist in many different forms, ranging from raw sugars and syrups to refined sugar and molasses.  These products are differentiated by their moisture, molasses, and sucrose content as well as by crystal size and any special treatments (e.g., treatment with sulfur).[2] Sugar cane products with common or usual names established by regulation are sugar (21 CFR 101.4(b)(20)) and cane syrup (alternatively spelled “syrup”) (21 CFR 168.130).  Several other sugar cane products have common or usual names established by common usage (e.g., molasses, brown sugar, turbinado sugar, muscovado sugar, and demerara sugar).  For purposes of ingredient labeling, “sugar” is defined to mean sucrose obtained from sugar cane or sugar beets in accordance with 21 CFR 184.1854, the regulation affirming that sucrose is generally recognized as safe (GRAS) for use in food when used under specified conditions.  The GRAS regulation describes sucrose as the substance “obtained by crystallization from sugar cane or sugar beet juice that has been extracted by pressing or diffusion, then clarified and evaporated” (21 CFR 184.1854(a)).  To be GRAS for use in food, sucrose must be of a purity suitable for its intended use (21 CFR 184.1854(b)).

On October 7, 2009, FDA published a draft guidance entitled “Guidance for Industry: Ingredients Declared as Evaporated Cane Juice” in the Federal Register (74 FR 51610) to advise industry of FDA’s view that the common or usual name for the solid or dried form of sugar cane syrup is “dried cane syrup,” and that sweeteners derived from sugar cane syrup should not be declared on food labels as “evaporated cane juice” because that term falsely suggests the sweeteners are juice.  On March 5, 2014, we reopened the comment period (79 FR 12507) for the draft guidance seeking further comments, data, and information about how the ingredient sometimes declared as “evaporated cane juice” is produced, what its basic nature and characterizing properties are, and how it compares with other sweeteners made from sugar cane.  We received numerous comments on the draft guidance.  The majority of comments objected to the term “dried cane syrup.”  Several comments from sugar producers asserted that this term does not accurately describe the ingredient they produce, mostly because the standardized food “cane syrup” is not the starting material or an intermediate step for the ingredient they refer to as “evaporated cane juice.”  Based on comments stating that the ingredient sometimes declared as evaporated cane juice is not made from cane syrup as defined in 21 CFR 168.130, FDA is no longer recommending that this ingredient be labeled as “dried cane syrup.”

Many comments described the process used to manufacture the ingredient described as “evaporated cane juice,” and some comments also described the manufacturing process for other products derived from sugar cane.  The initial processing steps are generally the same for all products produced from sugar cane.  After sugar cane is harvested, it is cut or shredded and then crushed to extract the fluid.  The extracted fluid is clarified and then evaporated to concentrate the solids.  To make the product “evaporated cane juice,” the concentrated cane extract is filtered and undergoes a single crystallization process.  The crystals are then separated from the molasses using centrifugation.  From the comments, the method of filtering the “evaporated cane juice” fluid varies from producer to producer, as does the method used for single crystallization.

Most other common types of cane sugar (e.g., white sugar, brown sugar) are not filtered prior to the first crystallization.  After the crystals are separated from the molasses using centrifugation, as part of the refining process, the sugar is melted and re-crystallized.  Most cane-based sweeteners, including white sugar, undergo multiple crystallization steps.

Some comments stated that “evaporated cane juice” has essentially the same composition as white sugar and other sweeteners derived from sugar cane.  As support for this point, one comment provided a specification sheet for “evaporated cane juice” indicating that the ingredient contains between 99.0 and 99.8% sucrose.  The comment also included a specification sheet for another product identified as “certified organic sugar” and pointed out that the composition of the two products was identical except that the organic ingredient was made with organic sugar cane.  Other comments focused on the differences between “evaporated cane juice” and other cane-based sweeteners.  For example, some of these comments stated that “evaporated cane juice” has a different composition from white sugar because it retains traces of molasses and minerals.  A few comments said that “evaporated cane juice” is different than other less refined, “alternative” sugars because it contains less molasses and can be substituted for white sugar in processed foods without affecting the taste or appearance of the finished product.

III. Discussion

This guidance is intended to help consumers make informed choices among sweeteners by promoting accurate and consistent labeling.  To that end, we are advising the regulated industry of our view that the term “evaporated cane juice” is not the common or usual name of any type of sweetener and that this ingredient should instead be declared on food labels as “sugar,” preceded by one or more truthful, non-misleading descriptors if the manufacturer so chooses  (e.g., “cane sugar”).

In developing this guidance, FDA reviewed the Codex Alimentarius Commission’s (Codex’s) Standard for Sugars, Codex Stan. 212-1999 (Ref. 4), which provides standards for certain sugars intended for human consumption without further processing, to determine whether Codex had established a standard for a product similar to that described on some U.S. food labels as “evaporated cane juice.”  The Codex Standard for Sugars contains no product identified as “evaporated cane juice.”  However, the Codex standard does define “raw cane sugar”[3] as “[p]artially purified sucrose, which is crystallised from partially purified cane juice, without further purification, but which does not preclude centrifugation or drying, and which is characterised by sucrose crystals covered with a film of cane molasses.”  This standard appears to describe the same sweetener referred to in many of the comments as “evaporated cane juice.” We agree that the common or usual name used to describe this ingredient on food labels should include the term “sugar” because that term describes the basic nature and characterizing properties of the food.

In contrast, the term “evaporated cane juice” describes neither the basic nature of the food nor its characterizing properties, and therefore does not comply with 21 CFR 102.5(a).  “Juice” is defined by 21 CFR 120.1(a) as “the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.”  This relatively narrow definition is the one used for purposes of the juice hazard analysis and critical control point (HACCP) regulations (21 CFR Part 120) and the juice labeling regulation in 21 CFR 101.30.  There are broader definitions of “juice” that are used in other contexts.  For example, in the context of botany and food technology, “juice” is a general term referring to the fluid extract of any plant.[4] However, in the context of diet and nutrition, “juice” has the narrower meaning reflected in the definition of “juice” in 21 CFR 120.1(a), which covers only liquid obtained from fruits or vegetables.  Although we do not dispute that sugar cane is a member of the vegetable kingdom in the broad sense of classifying an article as “animal,” “vegetable,” or “mineral,” FDA considers the term “vegetable” in the context of the juice definition to refer more narrowly to edible plant parts that consumers are accustomed to eating as vegetables in their diet.  Sugar cane is not a vegetable in this sense.  While consumers can purchase pieces of sugar cane, consumers do not eat sugar cane as a “vegetable” but instead use it as a source of sugar by chewing on the cane or its fibers or by placing the cane in a beverage to sweeten it.  There are other plant juices used for human food that similarly are not “vegetable juice” or “fruit juice” for purposes of the juice definition; e.g., maple syrup and sorghum syrup.  In summary, our view is that the fluid extract of sugar cane is not the juice of a plant that consumers are accustomed to eating as a vegetable in their diet and is not, therefore, “juice” as contemplated by the regulation defining that term (Refs. 1, 3).

Sugar cane is clearly not considered a fruit or vegetable by experts in nutrition and health, nor do those experts consider the fluid extract of sugar cane to be a type of fruit or vegetable juice.  Rather, they consider it to be a source of sugar.  For example, the Department of Agriculture’s Center for Food Policy and Promotion lists “cane juice” and “sugar cane juice” among the many names for added sugars on its dietary guidance  Web site for consumers (Ref. 5).[5] A newsletter posted on the Department of Health and Human Services  Web site warns that “cane juice” is one of the ingredient names used to hide added sugar in beverages and recommends for health reasons that any fruit juice given to children be 100 percent fruit juice without any form of added sugar, including “cane juice.”[6] Dietary advice on health organization  Web sites is similar.  For example, the Mayo Clinic Web site lists “cane juice” and “cane syrup” as forms of added sugar that consumers should cut back on for better health and nutrition.[7] None of these  Web sites defines sugar cane as a vegetable or classifies the fluid extract of the sugar cane plant as “juice” that counts toward the recommended number of daily fruit and vegetable servings.

In FDA’s view, the common or usual name for the ingredient currently labeled as “evaporated cane juice” includes the term “sugar” and does not include the term “juice.”  The basic nature of the ingredient is that it is a sugar and its characterizing property is that of a sweetener.  FDA’s food labeling regulations provide that sucrose obtained from sugar cane or sugar beets in accordance with 21 CFR 184.1854 shall be referred to as “sugar” in ingredient labeling (21 CFR 101.4(b)(2)).  Section 184.1854(a) describes sucrose as the substance “obtained by crystallization from sugar cane or sugar beet juice that has been extracted by pressing or diffusion, then clarified and evaporated.”  Based on the numerous comments indicating that the ingredient declared as “evaporated cane juice” is produced in this manner, it follows that the common or usual name for the product should be or include “sugar.”  As discussed in the Background section, current names that are used for several other sweeteners made from sugar cane (e.g., turbinado sugar, demerara sugar, and muscovado sugar) are names that have been established by common usage.  In each instance, the basic nature of the food is described by use of the term “sugar.”  FDA would not object to the addition of one or more truthful, non-misleading descriptors before the common or usual name “sugar.”  Such a descriptor, which could be a coined term, could be used to distinguish the ingredient from white sugar and other sugars on the market by describing characteristics such as source, color, flavor, or crystal size.

Sweeteners derived from sugar cane should not be listed in the ingredient declaration by names such as “evaporated cane juice,” which suggest that the ingredients are made from or contain fruit or vegetable “juice” as defined in 21 CFR 120.1.  We consider such representations to be false and misleading under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(a)(1)) because they do not accurately describe the basic nature of the food and its characterizing properties (i.e., that the ingredients are sugars or syrups), as required by 21 CFR 102.5.

Because sweeteners derived from sugar cane are not “juice” as defined in 21 CFR 120.1, they should not be included in the percentage juice declaration on the labels of beverages that are represented to contain fruit or vegetable juice (see 21 CFR 101.30).  Section 101.30 requires the percentage of fruit or vegetable juice in beverages purporting to contain such ingredients to be declared on the label of the beverage.  FDA would consider a juice product sweetened with an ingredient derived from sugar cane and labeled as 100% fruit juice to be misbranded under section 403(a)(1) of the Act  (21 U.S.C. 343(a)(1)) because the “100% fruit juice” claim is false and misleading in that the product contains a non-juice sweetener in addition to the juice.  FDA would also consider such a product adulterated under section 402(b) of the Act (21 U.S.C. 342(b)) because the sweetener has been substituted for part of the juice.

The Growing Notoriety of Gluten-Free and Allergen-Free Foods: Canadian Food Inspection Agency Updates the Industry Labelling Tool

June 13, 2016 Canadian Food Inspection Agency updates the Industry Labelling Tool on Allergen-Free, Gluten-Free and Precautionary Statements.

shutterstock_245254981With the rising popularity of Gluten-Free foods and the proposed increase in food allergies, it is has become mandatory that pre-packaged food labels declare food allergens or gluten sources when present. Allergen statements appearing on food labels and promotional materials contribute to a consumer’s overall impression of a product. As such, these claims are subject to a number of requirements. In May 2016, the Canadian Inspection Food Agency updated their Industry Labeling Tool to provide supplementary information on Allergen-Free, Gluten-Free and Precautionary Statements requirements for food product labels.

Gluten-Free

In order for a food to be represented as “Gluten-Free”, it must comply with section B.24.018 of the Food and Drug Regulations (FDR). Health Canada and the Canadian Food Inspection Agency (CFIA) consider gluten protein below 20 ppm to generally not represent health risks to consumers with celiac disease. The CFIA also takes into consideration whether any present gluten is due to intentional addition or to cross-contamination. Provided appropriate methods of analysis are used, quantitative claims related to the amount of gluten in foods are permitted. “Low gluten” or “reduced gluten” claims are not permitted in Canada, as they are considered to be misleading. A “wheat-free” claim cannot be used interchangeably with a “Gluten-Free” claim, as gluten can be present in sources other than wheat.

Gluten-Free foods fortified to achieve levels of enrichment equivalent to those required in flour, according to section D.03.003 of the FDR and under specific conditions, are allowed. These foods however cannot be advertised to the general public. Over-fortification posing health risks may be subject to enforcement action by the CFIA.

Gluten-Free Oats, Canary Seeds and Beer

Health Canada has created a Marketing Authorization to permit Gluten-Free oats and foods made using Gluten-Free oats as ingredients, to be labelled as ‘Gluten-Free’. This claim however is not permitted for use on regular oats or products containing these oats. Health Canada has published a guidance document on the requirements applicable to “Gluten-Free oat” label claims.

Canary seeds do not contain gluten and under certain conditions may be represented as Gluten-Free. Canary seeds do however contain other proteins similar to proteins associated with wheat allergies. As such, Health Canada has deemed it inappropriate for canary seed, or food containing canary seed, to be labelled as “wheat-free claim”. Health Canada also requires canary seed and foods containing canary seed to be labelled with a statement to the effect that the product “may not be suitable for people with wheat allergy”, provided the food does not also contain wheat as an ingredient.

Health Canada and the CFIA object to the use of Gluten-Free claims in beer products made from gluten containing grains. They do however, permit the use of the statement “This product is fermented from grains containing gluten and [processed or treated or crafted] to remove gluten. The gluten content of this product cannot be verified, and this product may contain gluten”. Beer-like products made from non-gluten grains are permitted to make Gluten-Free claims.

Precautionary Statements

Food allergen Precautionary Statements can be made on a voluntary basis when the presence of allergens in food is unavoidable. Mandatory food allergen and gluten declarations are required when an allergen or allergen-containing ingredients are deliberately added to a food.

As an industry best practice, Health Canada and the CFIA recommend use of only the following Precautionary Statement on food labels: “may contain [X]” (where X is the name by which the allergen is commonly known). It is also best practice for these Precautionary Statements be placed after any allergen “contains” statement or immediately after the list of ingredients.

The principles outlined in the information for Canadians with mustard allergy published by Health Canada, may be also be used to assess whether other Precautionary Statements be carried over to the end food product.

Allergen-Free

Due to the large number of food proteins with potential to cause adverse reactions in certain individuals, general “Allergen-Free” and “No Allergens” claims are not permitted. Allergen-Free claims such as “(naming the food allergen)-free” and “contains no (naming the food allergen)”, are permitted only in foods that have been specially formulated or are processed under special conditions. The CFIA requires that production systems or process controls be put in place to ensure consumers are not mislead as to the safety of the food. These claim may not be used in conjunction with a “may contain (naming the same allergen)”, except under specific conditions. (Naming the food allergen source)-free symbols and representations fall privy to the same requirements as Allergen-Free claims. It is recommended that clarifying text accompany these symbols to avoid misinterpretations.

Regulated parties are responsible for the safety of their products, including addressing potential risks associated with the presence of allergens. When making Gluten-Free, Allergen-Free and Precautionary Statements on food labels, manufacturers may be requested to provide evidence to substantiate these claims. During inspections, CFIA inspectors may ask how potential health risks to allergic consumers are being addressed.

dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can be reached at 1-866-647-3279 or info@dicentra.com.

Xylitol: Sugar Substitute that can Poison your Dog

ucm500188An article taken from the FDA website concerning sugar substitutes – found in some human foods and dental products that can be poisonous to your dog.

Original Article Found On: www.fda.gov

Your six-month-old puppy, Hoover, will eat anything that isn’t tied down. Like many dog owners, you know chocolate can be dangerous to your pooch. But you may not know that if Hoover sticks his nose in your handbag and eats a pack of sugarless chewing gum, the consequences could be deadly.

Sugarless gum may contain xylitol, a class of sweetener known as sugar alcohol. Xylitol is present in many products and foods for human use, but can have devastating effects on your pet.

Over the past several years, the Center for Veterinary Medicine at the U.S. Food and Drug Administration (FDA) has received several reports—many of which pertained to chewing gum—of dogs being poisoned by xylitol, according to Martine Hartogensis, a veterinarian at FDA.

And you may have seen recent news stories about dogs that have died or become very ill after eating products containing xylitol.

Other Foods Containing Xylitol

But gum isn’t the only product containing xylitol. Slightly lower in calories than sugar, this sugar substitute is also often used to sweeten sugar-free candy, such as mints and chocolate bars. Other products that may contain xylitol include:

  • breath mints
  • baked goods
  • cough syrup
  • children’s and adult chewable vitamins
  • mouthwash
  • toothpaste

Why is Xylitol Dangerous to Dogs, but Not People?

In both people and dogs, the level of blood sugar is controlled by the release of insulin from the pancreas. In people, xylitol does not stimulate the release of insulin from the pancreas. However, it’s different in canines: When dogs eat something containing xylitol, the xylitol is more quickly absorbed into the bloodstream, and may result in a potent release of insulin from the pancreas.

This rapid release of insulin may result in a rapid and profound decrease in the level of blood sugar (hypoglycemia), an effect that can occur within 10 to 60 minutes of eating the xylitol. Untreated, this hypoglycemia can quickly be life-threatening, Hartogensis says.

Symptoms to Look For in Your Dog

Symptoms of xylitol poisoning in dogs include vomiting, followed by symptoms associated with the sudden lowering of your dog’s blood sugar, such as decreased activity, weakness, staggering, incoordination, collapse and seizures.

If you think your dog has eaten xylitol, take him to your vet or an emergency animal hospital immediately, Hartogensis advises. Because hypoglycemia and other serious adverse effects may not occur in some cases for up to 12 to 24 hours, your dog may need to be monitored.

(A note to cat owners: The toxicity of xylitol for cats has not been documented. They appear to be spared, at least in part, by their disdain for sweets.)

What Can You Do to Avoid Xylitol Poisoning in Your Dog?

“If you’re concerned about your dog eating a food or product with xylitol in it, check the label of ingredients. If it does, indeed, say that it contains xylitol, make sure your pet can’t get to it.” Hartogensis says. In addition:

  • Keep products that contain xylitol (including those you don’t think of as food, such as toothpaste) well out of your dog’s reach. Remember that some dogs are adept at counter surfing.
  • Only use pet toothpaste for pets, never human toothpaste.
  • If you give your dog nut butter as a treat or as a vehicle for pills, check the label first to make sure it doesn’t contain xylitol.

You Can Help FDA by Reporting Safety Issues

FDA wants to know if your pet encounters safety issues with a product, and/or unanticipated harmful effects that you believe are related to a product.

“Timely reporting of problems enables FDA to take prompt action,” Hartogensis says. Each report is evaluated to determine how serious the problem is and, if necessary, additional information may be requested from the person who filed the report.

You can report problems related to both human and pet foods and treats at the Safety Reporting Portal.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Final Guidance Q&A for Medical Foods Posted by FDA

Re-posting FDA’s article on their Final Guidance Q&A for Medical Foods.

Original Article Found On: www.fda.gov

shutterstock_108106139I. Introduction

This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods. The responses to these FAQs address common questions about the definition of and regulations for medical foods. This guidance is a second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.” This guidance provides responses to additional questions regarding the definition and labeling of medical foods and updates some of the prior responses.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidances means that something is suggested or recommended, but not required.

II. Questions and Answers

1. What is a medical food?

A medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”

FDA considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food (21 CFR 101.9(j)(8)). Medical foods are distinguished from the broader category of foods for special dietary use by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision, and intended for the specific dietary management of a disease or condition. Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition. Not all foods fed to patients with a disease, including diseases that require dietary management, are medical foods. Instead, medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who requires use of the product as a major component of a disease or condition’s specific dietary management.

2. Has FDA established by regulation any criteria that clarify the statutory definition of a medical food?

Yes. The following criteria that clarify the statutory definition of a medical food can be found in FDA’s regulations at 21 CFR 101.9(j)(8). A medical food is exempt from the nutrition labeling requirements of 21 CFR 101.9 only if:

  1. It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube, meaning a tube or catheter that delivers nutrients beyond the oral cavity directly into the stomach or small intestine; [2]
  2. It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;
  3. It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
  4. It is intended to be used under medical supervision; and
  5. It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

We discuss nutrition labeling requirements and medical foods in questions 4 to 6 below.

3. Does FDA regulate medical foods as drugs?

No. Medical foods are not drugs and, therefore, are not subject to any regulatory requirements that specifically apply to drugs.

4. Do the labeling requirements for nutrient content claims apply to medical foods?

Medical foods are exempt from the labeling requirements for health claims under the Nutrition Labeling and Education Act of 1990 (see 21 U.S.C. 343(r)(5)(A)). As with any food, a medical food that bears a false or misleading claim would be considered misbranded under section 403(a)(1) of the FD&C Act.

5. Do the labeling requirements for health claims apply to medical foods?

Medical foods are exempt from the labeling requirements for health claims under the Nutrition Labeling and Education Act of 1990 (see 21 U.S.C. 343(r)(5)(A)). As with any food, a medical food that bears a false or misleading claim would be considered misbranded under section 403(a)(1) of the FD&C Act.

6. What labeling requirements apply to medical foods?

The labeling for medical foods must comply with all applicable food labeling requirements except for those specific requirements from which medical foods are exempt.

Specifically, the labeling of medical foods must contain:

  • A statement of identity (21 CFR 101.3);
  • An accurate statement of the net quantity of contents (21 CFR 101.105);
  • The name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5); and
  • A complete list of ingredients, listed by their common or usual name and in descending order of predominance (21 CFR 101.4).

In addition, all words, statements, and other information required by or under authority of the FD&C Act to appear on a label or labeling of a medical food must appear with prominence and conspicuousness (21 CFR 101.15) and be in English except that, for medical foods distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English (21 CFR 101.15(c)(1)). Further, if a label bears any representation in a foreign language, then all mandatory label information must be repeated in each foreign language used on the label (21 CFR 101.15(c)(2)).

Medical food labels must also conform with the principal display panel requirements under 21 CFR 101.1 and the applicable information panel requirements under 21 CFR 101.2. Further, the requirements concerning the misbranding of food (21 CFR 101.18) apply to medical foods.

7. What other FDA requirements apply to medical foods?

Manufacturers of medical foods must comply with all applicable FDA requirements for foods, including the following regulations:

  • Current good manufacturing practice (21 CFR part 110);
  • Registration of food facilities (21 CFR part 1 subpart H);
  • Thermally processed low-acid foods packaged in hermetically sealed containers (21 CFR part 113);
  • Acidified foods (21 CFR part 114); and
  • Emergency permit control (21 CFR part 108).

8. Does the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) apply to medical foods?

Yes. FALCPA’s labeling requirements apply to all foods other than raw agricultural commodities, including medical foods.

9. Where can I find more information on FALCPA’s labeling requirements?

You can find more information on FALCPA’s labeling requirements on FDA’s Web site.

10. What are the registration requirements for medical food facilities?

Any facility engaged in manufacturing, processing, packing, or holding medical foods for consumption in the United States must register with FDA.[3] You can find additional information regarding the registration of food facilities on FDA’s Web site.

11. Does FDA maintain a list of medical foods?

FDA does not maintain a comprehensive list of medical food products.

12. Is there a compliance program guidance manual for medical foods?

Yes. FDA has a compliance program guidance manual entitled “Medical Foods Program – Import and Domestic” that is available on FDA’s Web site.

13. What is the purpose of FDA’s compliance program for medical foods?

FDA’s compliance program gives direction to FDA inspectors on: (1) obtaining information regarding the manufacturing/control processes and quality assurance programs employed by domestic manufacturers of medical foods through establishment inspections; (2) collecting domestic and import surveillance samples of medical foods for nutrient and microbiological analyses; and (3) recommending action when significant violations of the FD&C Act (or related regulations) are found.

14. Does FDA require that medical foods be made available by written or oral prescription?

No. The requirement for a written or oral prescription in section 503(b) of the FD&C Act and its implementing regulations at 21 CFR 201.100 only applies to the dispensing of prescription drug products. The Orphan Drug Act provides that medical foods must be formulated to be consumed or administered enterally under the supervision of a physician, but there is no requirement for a prescription.

15. How does FDA interpret “under the supervision of a physician”?

FDA considers the requirement that a medical food be formulated to be consumed or administered enterally under the supervision of a physician to mean that the intended use of a medical food is for the dietary management of a patient receiving active and ongoing medical supervision (e.g., in a health care facility or as an outpatient) by a physician who has determined that the medical food is necessary to the patient’s overall medical care. The patient should generally see the physician on a recurring basis for, among other things, instructions on the use of the medical food as part of the dietary management of a given disease or condition.

16. May the labeling of a medical food bear the symbol “Rx only”?

The labeling of medical foods may not bear the symbol “Rx only.” Section 503(b)(4)(A) of the FD&C Act (21 U.S.C. 353(b)(4)(A)) provides that a prescription drug is misbranded if the label of the drug fails to bear, at a minimum, the symbol “Rx only” to indicate that the product may not lawfully be dispensed without a prescription. Unlike prescription drugs, medical foods are not required by federal law to be dispensed by prescription. Therefore, the use of the symbol “Rx only” in the labeling of a medical food would misbrand a medical food under section 403(a)(1) of the FD&C Act because it would be a false and misleading statement about that product. However, because medical foods are required by statute to be formulated to be consumed or administered enterally under the supervision of a physician, FDA would not object to the use of language to communicate this requirement in the labeling of a medical food product that is not false or misleading (e.g., “must be used under the supervision of a physician”).

17. Should National Drug Code (NDC) numbers be used in the labeling of medical foods?

The labeling of medical foods should not include NDC numbers. Drug products are identified and reported using a unique, three-segment number, called the NDC, which is a universal product identifier for human drugs.[4] NDC numbers are intended for uniquely identifying drugs and should not be used in the labeling of medical foods since they are not drugs. The presence of an NDC number on a food product that is not a drug misbrands the product under section 403(a)(1) of the FD&C Act. In addition, any representation that creates an impression of official FDA approval through the use of an NDC number in labeling constitutes misbranding.[5]

18. What requirements apply to ingredients added to medical foods?

An ingredient that is added to a medical food should be safe and in compliance with all applicable provisions of the FD&C Act and FDA regulations. Any ingredient added to a medical food should be: (1) a food additive used in accordance with FDA’s food additive regulations (see 21 CFR part 172); (2) a color additive used in accordance with the color additive regulations (see 21 CFR parts 73 and 74); (3) a substance that is generally recognized, by qualified experts, to be safe under the conditions of its intended use (generally recognized as safe (GRAS)) (see 21 CFR 170.30 and 21 U.S.C. 321(s)); or (4) a substance that is authorized by a prior sanction (see 21 CFR 170.3(l), 21 U.S.C. 321(s)(4)).

19. Where can I find additional information on food additives and GRAS ingredients?

Additional information on food additives and GRAS ingredients can be found under the food topic “Ingredients, Packaging & Labeling” on FDA’s Web site.

20. Does FDA generally consider inborn errors of metabolism (IEMs) to be diseases or conditions that a medical food could be used to manage?

Yes. FDA generally considers IEMs to be diseases or conditions that a medical food could be used to manage. IEMs include inherited biochemical disorders in which a specific enzyme defect interferes with the normal metabolism of protein, fat, or carbohydrate. As a result of diminished or absent enzyme activity in these disorders, certain compounds accumulate in the body to toxic levels, and levels of other compounds that the body normally makes may become deficient (Ref. 1). Without appropriate and accessible management, these metabolic disturbances can lead to a host of medical and developmental consequences ranging from intellectual disability to severe cognitive impairment and even death (Ref. 1). Management may include one or a combination of the following: drug therapy, modification of the normal diet, or use of a medical food.[6]

Some of these disorders can be managed with modification of the normal diet alone (e.g., reduction of galactose and lactose for galactosemia). However, others cannot be managed solely with diet modification. For these IEMs, a medical food is required in addition to a specific dietary modification in order to obtain adequate levels of essential nutrients (e.g., essential amino acids, essential fatty acids) that are restricted by modifying the normal diet. Medical foods become indispensable for individuals with these IEMs in order to meet the daily requirements of essential nutrients and to limit the metabolic disturbances associated with the particular IEM (e.g., see question 21).

21. Are there any examples of specific IEMs that medical foods could be used to manage?

Yes. Some examples of specific IEMs that medical foods could be used to manage involve amino acid/protein, organic acid, or fatty acid metabolism. These IEMs primarily require significant restriction of particular amino acids and/or total protein such as in phenylketonuria (phenylalanine restriction), ornithine transcarbamylase deficiency (nonessential amino acid restriction), methylmalonic acidemia (isoleucine, methionine, threonine, and valine restriction), or significant modification of fatty acids/total fat such as in very long-chain acyl-CoA dehydrogenase deficiency (long chain fatty acid restriction with an increase in medium chain fatty acid levels).

22. Does FDA consider pregnancy to be a disease?

FDA does not consider pregnancy to be a disease.[7]

23. Are there distinctive nutritional requirements associated with pregnancy?

No. There are no distinctive nutritional requirements associated with pregnancy. Essential nutrient requirements to support pregnancy can be met by diet modification. The Institute of Medicine (IOM) established nutrient recommendations to meet essential nutrient requirements associated with pregnancy. Pregnancy is one of the twelve life stage groups identified by the IOM. For each life stage group, where data were available, IOM established dietary reference intakes (DRIs) to apply to the healthy general population. DRIs are standards for apparently healthy people and are not meant to be applied to those with acute or chronic disease or for the repletion of nutrient levels in previously deficient individuals (Ref. 2).

24. Does FDA consider pregnancy to be a condition for which a medical food could be labeled and marketed?

Under 21 CFR 101.9(j)(8)(ii), a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone. While some diets may not supply the full amount of nutrients necessary for women who are pregnant or planning to become pregnant, generally the levels of micronutrients necessary for pregnancy can be achieved by the modification of the normal diet alone. It is generally practicable for women who are pregnant or planning to become pregnant to follow the IOM and FDA recommendations for nutrient intake within a normal diet. Therefore, FDA generally would not consider a product labeled and marketed for pregnancy to meet the regulatory criteria for a medical food.

25. Are there distinctive nutritional requirements associated with the management of diabetes mellitus (DM)?

No. There are no distinctive nutritional requirements associated with the management of DM. Essential nutrient requirements for individuals affected by DM are no different than those for unaffected (generally healthy) persons. Following an individualized healthy, well-balanced diet is crucial to managing conditions such as DM. There are nutritional recommendations established for persons to manage DM (Refs. 3, 4, and 5).

26. Does FDA consider DM to be a condition for which a medical food could be labeled and marketed?

No. Diet therapy is the mainstay of diabetes management. A regular diet can be modified to meet the needs of an individual affected by DM (along with appropriate drug therapy if necessary). Under 21 CFR 101.9(j)(8)(ii), a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.

27. Does FDA consider diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) to be diseases for which a medical food could be labeled and marketed?

No. Diseases (e.g., scurvy, pellagra) that result from essential nutrient deficiencies (e.g., deficiencies of vitamin C, niacin) are primarily caused by inadequate intake (e.g., famine, significant calorie restriction, eating disorders, alcoholism, diet practices/fad diets). The deficiencies, excluding any permanent physical damage, can typically be corrected once foods with these essential nutrients (or dietary supplements, if necessary) are made available and/or consumed. Because such diseases can typically be managed through consumption of a healthy, well-balanced diet, FDA generally would not consider a product labeled and marketed for these diseases to meet the statutory and regulatory criteria for a medical food (see 21 CFR 101.9(j)(8)(ii)).

28. Does FDA consider conventional foods that, in their natural state, do not contain protein or are low in protein to meet the definition of a medical food?

No. Conventional foods such as fruits, certain vegetables, fats, and sugars generally are not specially formulated to be significantly low in protein or to contain no protein—instead, they are low in protein in their natural state. Under 21 CFR 101.9(j)(8)(i), a medical food must be a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube. Therefore, conventional foods that do not ordinarily contain protein or are ordinarily low in protein would not meet the statutory and regulatory criteria for medical foods.

III. References

We have placed the following references on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday. As of April 12, 2016, FDA had verified the Web site address for the references it makes available as hyperlinks from the Internet copy of this guidance, but FDA is not responsible for any subsequent changes to Non-FDA Web site references after April 12, 2016.

1. Camp, K., Lloyd-Puryear, M., Huntington, K. Nutritional treatment for inborn errors of metabolism: Indications, regulations, and availability of medical foods and dietary supplements using phenylketonuria as an example. Molecular Genetics and Metabolism, 107:3-9, 2012. Available: http://www.ncbi.nlm.nih.gov/pubmed/22854513.

2. Otten, J., Hellwig, J., Meyers, L. eds. Institute of Medicine. Dietary Reference Intakes. The Essential Guide to Nutrient Requirements, Part 1: Development and Application, Introduction to the Dietary Reference Intakes and Applying the Dietary Reference Intakes, pp. 5-17, 2006.

3. American Diabetes Association. Nutrition Therapy Recommendations for the Management of Adults With Diabetes. A Position Statement of the American Diabetes Association. Diabetes Care, 37(1):S120-S143, January 2014. Available: http://care.diabetesjournals.org/content/37/Supplement_1/S120.full.pdf+html.

4. Standards of Medical Care in Diabetes 2016, American Diabetes Association, Diabetes Care. 39 (Supplement 1): S1-S112, January 2016. Available: http://professional.diabetes.org/content/clinical-practice-recommendations.

5. Centers for Disease Control and Prevention. Eat Right! www.cdc.gov/diabetes/consumer/eatright.htm (accessed April 12, 2016).

Food and Nutrition Expert Joins dicentra

Dr. Raj Akilen, PhD, Scientific Regulatory Specialist, has joined dicentra – a safety, quality and regulatory consulting firm operating in Toronto, Ontario. Raj joins dicentra with 10 years of clinical and research experience in Food and Nutritional Sciences. In his last position Raj was working as a Post doctoral Research Fellow at the Department of Nutritional Science, Faculty of Medicine, at the University of Toronto. He has also worked as the Scientific Advisor for the sales promotion and marketing team at Novartis Pharmaceuticals. Raj’s dynamic skill set has also given him a comprehensive understanding of the clinical research process, including Good Clinical Practices (GCP) and ethical, governmental and regulatory requirements as they relate to food research and to the food industry.

Raj’s educational credentials include a PhD in Nutrition from the Faculty of Health and Human Sciences, University of West London (UWL), a PG Diploma in Research Methods from the Faculty of Health and Human Sciences, UWL, and also a BSc (Hons) in Food and Nutrition, where he specialized in Human Nutrition.

Raj is also a very accomplished published author in many medical journals, including Diabetes Medicine, Clinical Nutrition, Journal of Nutrition, Advances in Nutrition and the Journal of Integrative Medicine – to name a few.

“We are very excited to welcome Dr. Akilen to our team,” reports Peter Wojewnik, VP of Business Development at dicentra. “The food and nutrition industry has been exploding with innovation in recent years and we continue to be challenged by our clients with the most unique and demanding clinical and regulatory matters. Dr. Akilen will significantly add to the diversity of our team and allow us to continue serving our clients to the best of our ability.”

About dicentra

Since 2002, dicentra has been helping clients resolve complex scientific and regulatory issues, develop safe and effective market-leading products and facilitate timely regulatory approvals. dicentra has been directly involved in the successful development of hundreds of leading products in North America and through out the world.

For further information or for press inquiries please contact:

Peter Wojewnik
Vice President of Business Development
dicentra Inc.
416-361-3400 ext 225

 

Meet dicentra in 2016

dicentra will be participating in various trade show exhibitions and conferences throughout this year. Get the chance to meet us at our booth at the following upcoming 2016 shows:

  • GFTC – Canadian Food Safety Forum | February 25, 2016 [Brampton, ON]
  • Engredea + Expo West | March 9 – 13, 2016 [Anaheim, CA]
  • Ingredient Marketplace | April 27 – 29, 2016 [Orlando, FL]
  • Vitafoods – Europe | May 10 – 12, 2016 [Geneva, Switzerland]
  • Agri Investment Forum | May 11 – 12, 2016 [Toronto, ON]
  • DSA – USA Annual Meeting | June 5 – 8, 2016 [Phoenix, AZ]
  • NBJ Summit | June 13 – 16, 2016 [Dana Point, CA]
  • CHFA – East | September 17 – 18, 2016 [Toronto, ON]
  • Supplyside West | October 4 – 8, 2016 [Las Vegas, NV]

 

We look forward to seeing you there!

dicentrateamsmall

The Grace Period Dilemma – What you need to know when it comes to NHPs, TMAs and GMO Labelling

By Peter Wojewnik, VP Business Development

http://issuu.com/rivegauche/docs/ihr_june_2014/50

Reprinted from IHR, June 2014

dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. Contact us at info@dicentra.com or at 1-866-647-3279.

Personal Use Importation – Canada’s best kept regulatory secret for supplements?

Reprinted from Functional Ingredients

Many are already aware of Canada’s much more stringent and cumbersome regulatory model for supplements (called Natural Health Products, or NHPs, in Canada). Every product needs to be licensed by Health Canada, which requires a tedious application for one, but then takes forever to receive a response from the government. And then there are the importation requirements. Things like an importer of record, domestic site license, annexation of foreign sites and other unfamiliar and confusing things have to be put in place before any company outside of Canada can send any product in.

What’s surprising to most is that there’s actually an exemption to all of these rules. That statement usually stirs a lot of excitement in companies we talk to. It’s what Health Canada calls Personal Use Importations. The intent of the whole exemption is to allow Canadian citizens access to medicines that are not available in Canada. Essentially, Canadians can order product from any foreign country and that product does have to be reviewed and licensed by Health Canada and the importation requirements mentioned above do not have to be met.

There are, however, five firm rules.

  • One, the customer is only permitted to import (per shipment) a 90 day or less supply based on the directions of use.
  • Two, the product must be for that individual’s own use, and not for resale.
  • Three, it must be shipped directly to the end user, and not a commercial establishment.
  • Four, there can be no Canadian intermediary (such as a broker or salesperson).
  • Five, it cannot contain any Schedule F (prescription) ingredients.

If any of these rules are not met, and the Canadian Border Services Agency (CBSA) notices it, product may be required to be immediately returned to the country of origin, disposed of, or forfeited to Health Canada.

We suddenly realize that this is not the type of business model most companies can operate under, especially if your product is being distributed to retail locations. For some business models, however, it has worked tremendously well. Two in particular: E-commerce websites shipping orders to customers in Canada, and Direct Sellers. Since the inception of our regulatory system for NHPs in 2004 these companies have been able to ship products to their customers in Canada without having to meet any of the regulatory requirements. And there’s nothing wrong with that!

Actually, there is one problem. It’s been used a lot lately and the frequency is increasing. Health Canada is well aware of this and during recent bilateral meetings and government workshops the health authority has expressed its concern that the exemption clause is being abused. Talks about tightening up the rules have emerged. Health Canada believes that some foreign companies are taking advantage of this clause to skirt the regulatory requirements. They’re not alone in thinking this. “Part of the driving force behind Health Canada’s desire to tighten up the Personal Use exemption and how it is applied is industry itself,” reports William Morkel, Director of QA at dicentra. “Many companies see this clause as giving an unfair advantage to foreign companies who don’t have to abide by site licensing and product licensing requirements.”

If, how and when the rules are tightened remains to be determined. One point to keep in mind is that the entire Personal Use clause was primarily developed to allow access to Canadians medicines that are not otherwise available in Canada. If someone wants to ship a common product, say 500mg Vitamin C, which is already abundantly available in Canada, then technically the Personal Use clause would not apply. This may be one of the ways in which Health Canada and the CBSA cracks down on these types of imports. Companies with significant business in Canada are already taking the necessary steps to license their products and assign an importer even though they continue to operate under the Personal Use requirements. The ride’s been nice up until now. The time has come to take some measures to secure future business and minimize any potential risk.

Peter Wojewnik is the Vice President of Business Development for dicentra. dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces.

Link to original article:  http://newhope360.com/functional-ingredients/2013-11-06

Jon Benninger discusses the importance of GMP training

play video

 

GMP training doesn’t have to be complex, expensive and time consuming.

Dedicating time and resources to in-house training, or hiring costly outside consultants isn’t the only answer.

Make it easy with GMP Online Training from dicentra. GMP Online Training that’s easy to understand, easy to monitor, and easy on your budget.

Only GMP training from dicentra gives dietary supplement manufacturers, packagers, labellers and holders a complete understanding of what it takes to comply with the regulations. And if you have multiple locations, online training makes it even easier.

Because dicentra stays up to date on FDA’s requirements, you’re assured that the GMP training your people receive is current, accurate, and helpful.

  • Build a better team.
  • Create improved operating efficiencies.
  • Give your business a clear cut competitive advantage.

See for yourself how America’s leading dietary supplement manufacturers, packagers, labellers and holders are improving their operations, avoiding costly problems, and building more effective teams.

GMP Online Training from dicentra. The best way to make sure your organization is performing at its best today and is well positioned for tomorrow.

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SPECIAL ALERT: NHP Compliance and Enforcement Transition: Phase I ending December 1, 2013

dicentra Special Alert

November 8, 2013

Phase I of the NHP Compliance and Enforcement transition period is ending December 1, 2013. Companies have been advised to ensure that they are familiar with and in compliance with the Regulations.

In order to legally sell natural health products (NHPs) in Canada, you must have an NPN. However, there is currently an NHP compliance and enforcement “transition period” that allows products that have not received their market authorizations to be sold without being subject to enforcement actions.

From now until December 1, 2013 the Inspectorate will allow manufacturers, packagers, labellers, and importers of NHPs to sell their products without taking enforcement action if it meets the following criteria:

  • The product has a submission number (indicating that you filed a product license application)
  • The product is manufactured and/or imported through a Site Licensed facility
  • The product is not considered high risk (examples of high risk products are those indicated for children or pregnant women, or products that contain ingredients that have been the subject of recalls in the past)

As of December 1, 2013, all manufactured and imported products should have their NPNs and may be subject to enforcement action if they do not. From December 1, 2013 to September 1, 2014, products without an NPN can continue to be distributed and/or sold at retail without an NPN if they meet the above criteria. After September 2014, all products on the market must have an NPN in order to be legally sold.

As we are nearing the December 1 deadline it is advisable to manufacture, package, label and import your NHPs such that they meet the above criteria. While the Inspectorate has assured the industry that there has been no change in their NHP Compliance and Enforcement Policy and enforcement will continue to be risk based, they have indicated that actions will be focused on all activities including the supply chain. Additionally, enforcement will be based on whether a company has tried to come into compliance (i.e. do they have an application in queue for assessment).

dicentra can assist you with filing your product license applications, site license applications and conduct label reviews to ensure you are in compliance with the regulations. Additionally, to help ensure a smooth process at the border dicentra offers importation services through their site license.

dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. We can be reached at 1-866-647-3279 or info@dicentra.com.

GMP

Introducing…..

a new edition to the dicentra family…..

CatherineCatherine Jane Thurston

Born Saturday, October 12, 2013

7lbs, 5oz

 

 

Congratulations Ashleigh and Colin

As you welcome your new baby girl into your lives, we hope that you find parenthood to be an amazing and rewarding experience.  May you cherish every memory and succeed in everything that you and your princess set out to do.  Congratulations!

NHPD Issues Proposed Changes to the existing Compendium of Monographs Guidance Document, seeks Stakeholder Feedback

NHPD has released a revised Compendium of Monographs Guidance Document. This document is open for comment until October 26, 2013.

The NHPD has issued a revision to its Compendium of Monographs Guidance Document. The revision was based on changes resulting from the final Quality of Natural Health Products Guide (see our previous news item from July 15, 2013). The Compendium of Monographs, version 2.1 (November 2007) is being replaced by the revised draft guidance document Compendium of Monographs, version3.0 (June 2013). The revised document is available on the NHPD web site. This consultation is open for comment from August 28, 2013 until October 26, 2013.

Stakeholders are urged to review the draft guidance document and provide NHPD with comments. There are several changes incorporated into the new document, including a new listing of the types of monographs available to industry when filing new Product Licence Applications. It is important to provide feedback during these consultations so that NHPD can gauge the impact to industry of any proposed changes. Dicentra’s staff of regulatory experts can assist you with completing your compendial applications and advise when a compendial application is the correct choice.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or info@dicentra.com

SAVE THIS DATE: Free Regulatory Update Webinar: Tuesday, June 18th at 1 PM ET

 

Dicentra_newsletter_header3

Don’t miss our next free Regulatory Update Webinar of the year on Tuesday, June 18th at 1:00 PM EST. You are invited to join hundreds of companies already tuning in. Critical American and Canadian updates include an update on Proposition 65, GMO Labeling and Canada’s NHPD Status of Applications for the fourth quarter of 2012.

For more details about the presentation, topics and our speakers please continue to read below.

To register for the webinar, please click below:

 

register now

 

 

You will receive a confirmation email that schedules the event in your calendar and provides a link to join the meeting. You can register and join the meeting at any point. It all takes only a few minutes.

When you join the meeting you can use your computer speakers to listen in on the webinar.

You can not dial in with your phone to listen in. You must use computer speakers.

Please visit dicentra.com for weekly regulatory and scientific articles, special alerts and updates.

 

PRESENTATION TOPICS AND SPEAKERS

Heather - NewHeather Van Blarcom, General Counsel & Senior Regulatory Specialist for Dietary Supplements at dicentra will present on the following U.S. topics:

– Is reform of California’s Proposition 65 on the horizon?
– Where do we stand with GMO Labeling?
– What do you mean caffeine isn’t approved for use in food?
– I’m not a manufacturer, why do I have to comply with GMPs?
– We all know quality control is important, but what else is the FDA looking for?
– Why can’t I label my product as a medical food and make disease treatment claims?
– Are you still selling products with DMAA?

RW_William_2701William Morkel, Director of Quality & Compliance at dicentra, will present on the following Canadian topics:

– NHPD Status of Applications Quarterly Report (4th Quarter 2012)
– Consultation on the Issuance of International Trade Certificatges (for NHPs)
– New and proposed NHPD Monographs
– Establishment Licencing and GMP Requirements for Active Pharmaceutical Ingredients
– Guidance Document: Factors Influencing the Classification of Products at the Device-Drug interface
– Classification on Non-medicated Eyewashes
– Draft Guidance Document For Disinfectant Drugs
– “Local” Food Claims
– Food Inspection Modernization – Reminder

 

Please visit our website to view our previous webinars and to register for events. If you have any comments or questions do not hesitate to contact us!

Sincerely,

Peter Wojewnik
Vice President Business Development
dicentra
peter@dicentra.com

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NHPD Provides Update on Transition of Assessment of NHP Clinical Trial Applications for Primary Indications Inappropriate for Self-Care

The NHPD has Transitioned the Assessment of NHP Clinical Trial Applications (for primary indications inappropriate for self-care) and Adverse Reaction Reporting to the TPD.

Health Canada informed the industry through two notices, sent August 2012 and October 2012 of the two phases of a pilot program to streamline the review of NHP Clinical Trial Applications. The first phase of this program involved the transitioning of the assessment of Clinical Trial Applications for certain claims – i.e. those that are inappropriate for self-care, to the Therapeutics Products Directorate (TPD) or Biologics and Genetic Therapies Directorate (BGTD), as appropriate for review1. Amendments to NHP Clinical Trial Applications that are not appropriate for self care, will also be transitioned to the TPD. The second phase of this pilot program involved transitioning all adverse reaction reporting from NHP Clinical Trials to the TPD or BGTD, as appropriate. As of November 27, 2012, the NHPD officially started the transition to move NHP adverse reaction report files to the TPD and/or BGTD. It is important to note that all adverse reaction reporting for Clinical Trials of NHPs has been outsourced to the TPD and BGTD, not just for trials for claims that are inappropriate for self-care.

To help ease the transition the NHPD informed affected stakeholders (i.e. those identified as a contact on a NHP Clinical Trial Application) through notices that were sent out on August 1, October 5 and November 27, 2012 to expect a change in the reporting structure of clinical trials2. The NHPD has indicated that although assessment of NHP Clinical Trial Applications and Amendments to applications for products with indications inappropriate for self care is being transitioned to TPD a similar assessment approach will be maintained, and the same NHPD application forms are to be used. The only major change that you should be aware of is that there has been a significant reduction in the time provided by the NHPD to respond to Information Request Notices (IRNs) from 30 days to 2 days.

Currently, the NHPD is working to develop tools to ensure the transition of information is as seamless as possible, while allowing assessment officers at the TPD or BGTD access to the NHP Clinical Trial Application files. dicentra will be sure to inform you as soon as any new information on the NHP Clinical Trial Application transition is provided by Health Canada.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or info@dicentra.com

 

References:

1. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/bilat/rod-cr_12-03-12-eng.php

2. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/clini/nhp-psn-eng.php

New Study Finds Modest Reduction In Cancer In Middle-Aged And Older Heathy Men Taking Multivitamins

Council for Responsible Nutrition
www.crnusa.org

FOR IMMEDIATE RELEASE

Washington, D.C., October 17, 2012—A new study published today in JAMA (Journal of the American Medical Association) found “daily multivitamin supplementation modestly but significantly reduced the risk of total cancer” in a large population of healthy male physicians.

The multivitamin and cancer arm of the Physicians’ Health Study (PHS) II, the only large-scale, randomized, double-blind, placebo-controlled trial (RCT) to study the long-term effects of a multivitamin in chronic disease, was conducted by researchers at Brigham and Women’s Hospital and Harvard Medical School and will be presented today by lead corresponding author J. Michael Gaziano, M.D., M.P.H., at the annual American Association for Cancer Research Frontiers in Cancer Prevention Research meeting. PHS II studied nearly 15,000 male U.S. physicians aged 50 years and older for over a decade.

According to the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement industry, the well-designed study provides encouraging news, particularly for healthy men looking to remain healthy. “This study reinforces the value of long-term consistent use of a daily multivitamin as a convenient and affordable insurance policy for good health,” said Duffy MacKay, N.D., CRN’s vice president, scientific and regulatory affairs. “Whether or not this study can be generalized to the total population is not answered by this study; however, there are other well-researched benefits for the multivitamin in the general population.”

For example, women of child-bearing age are regularly advised to take a multivitamin with 400 mcg of folic acid to help prevent certain birth defects such as spina bifida. Additionally, many Americans, despite being overfed, are not getting the essential nutrients necessary for good health, and a daily multivitamin helps fill those nutrition gaps.

In fact, in CRN’s most recent annual consumer survey on dietary supplements, when asked why they take dietary supplements, vitamin/mineral users ranked “to help reduce the risk of serious illness” eighth on the list, with “overall health and wellness benefits” and “to fill in nutrient gaps in their diet” cited as the number one and two reasons, respectively.

Not only did this study provide good news for the supplement industry and its consumers, but it provided another reminder that science should be viewed in the context of the full body of scientific literature. For those who have previously tried to shut the door on the benefits of taking a multivitamin, this study, says Dr. MacKay, “pushes the door and the windows wide open to the benefits and safety of multivitamins.”

CRN urges the importance of keeping in mind that cancer is a multifactorial disease, and that even with the positive scientific news demonstrated by this study, consumers would be wise to also engage in other common-sense habits. Preventing chronic disease, such as cancer, likely involves the combination of long-term consistent, smart lifestyle choices, including a healthy diet, vitamins and other supplements, regular exercise, routine visits to your physician, and decreasing stress. Says Dr. MacKay, “By all means, take your daily multivitamin, as a supplement to, not a substitute for, other healthy lifestyle choices.”

Fact Box

  • The multivitamin is the most popular dietary supplement.1
  • 52 % of American adults take multivitamins; 42% of American adults take multivitamins regularly.1
  • 56% of American adult women and 48% of American adult men take multivitamins.1
  • 72% of physicians personally use dietary supplements and the multivitamin is the most popular dietary supplement taken by this population.2

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1Council for Responsible Nutrition. (2012). CRN Consumer Survey on Dietary Supplements. Retrieved October 4, 2012, from http://crnusa.org/CRNPR12-ConsumerSurvey100412.html

2 Dickinson A, Boyon N, Shao A. Physicians and nurses use and recommend dietary supplements: report of a survey. Nutrition Journal 2009, 8:29 doi:10.1186/1475-2891-8-29

Reminder of dicentra’s Free Regulatory Update Webinar – Tomorrow

June 18, 2012

Free Regulatory Update Webinar: Tuesday, June 19th at 1 PM ET

Dear dicentra Subscriber,

We’re sending you a quick reminder about our free Regulatory Update Webinar, tomorrow, Tuesday, June 19th at 1:00 PM EST. You are invited to join hundreds of companies already tuning in.

At dicentra we’re committed to keeping our clients and the industry connected and informed. This quarter’s webinar will include the latest updates and changes in the American and Canadian regulatory environments as they pertain to Natural Health products and Dietary Supplements.

For more details about the presentation, topics and our speakers please continue to read below.

To register for the webinar, please click below:

Register Now


You will receive a confirmation email that schedules the event in your calendar and provides a link to join the meeting. You can register and join the meeting at any point. It all takes only a few minutes.

When you join the meeting you can use your computer speakers to listen in on the webinar.

Please visit dicentra.com for weekly regulatory and scientific articles, special alerts and updates.

PRESENTATION TOPICS AND SPEAKERS

Dr. John Harrison, Senior Government Relations Advisor at dicentra, will present on the following Canadian topics:
  • Status of Unprocessed Product Licence Applications (UPLAR)
  • NHP Compliance and Enforcement Policy
  • Status of Applications
  • Products Currently “On Hold”
  • Consultations and Regulatory Initiatives

 

Heather VanBlarcom, General Counsel & Senior Regulatory Specialist for Dietary Supplements at dicentra will present on the following U.S. topics:
  • Dietary Supplements
  • GMPs
  • NDI’s

Don’t miss our next free Regulatory Update Webinar on Tuesday, September 18, 2012 at 1:00 PM EST.

Please visit regulatoryupdates.com to register.

Please visit our website to view our previous webinars and to register for events. If you have any comments or questions do not hesitate to contact us!

Sincerely,

Peter Wojewnik
Vice President Business Development
dicentra
peter@dicentra.com

The Drafts: Pathways for Licensing Natural Health Products Making Modern Health Claims & Used as Traditional Medicines: What does it mean for your NHPs?

By: Ashleigh Hampton, MSc
Manager, Scientific Affairs

On May 23, 2012, the Natural Health Products Directorate (NHPD) released the Draft: Pathway for Licensing Natural Health Products (NHPs) Making Modern Health Claims and the Draft: Pathway for Licensing NHPs Used as Traditional Medicines guidance documents. The following details will highlight the proposed changes and outline how it will impact the evidence needed to obtain your desired claims.

Draft: Pathway for Licensing NHPs Making Modern Health Claims

This guidance document provides insight into the manner in which the NHPD plans to review the non-traditional NHP Product License Applications (PLA). The main objective of this draft guidance document is to outline the risk-based approach proposed to be taken by the NHPD when assessing the evidence provided to support the safe and effective use of your NHPs.

The NHPD has categorized the types of claims applicants may wish to apply for into 3 categories:

  1. High Level of Risk (e.g. products claiming to treat/prevent/cure serious diseases, such as those present on Schedule A of the Food and Drug Act)
  2. Medium Level of Risk (e.g. products claiming to treat/prevent/cure major diseases or health conditions which may not be resolved in a timely manner and which if untreated may worsen or persist, such as hypercholesterolemia)
  3. Low Level of Risk (e.g. products containing ingredients which have good evidence to support their safe use and are making general health maintenance/support claims, treatment/prevention claims for minor diseases or risk reduction claims for major diseases or health conditions).

In summary the evidence required to support the safe use of your product will be dependent on the strength of the claims you wish to make. The NHPD’s Pre-Cleared Information (PCI) stands as the most acceptable evidence available. Second to which are high quality phase III clinical trials and the inclusion of 2 prospective observational studies, with some additional required study criteria. These types of evidence will be sufficient to support all types of health claims.

To support your low and lowest risk health claims the following types of evidence will be acceptable to support the safety and efficacy of your product:

  • Meta-analysis
  • Evidence from a regulatory agency
  • Systematic reviews
  • Phase II clinical trial
  • 2 Retrospective observational study
  • 2 Epidemiological studies
  • Published, peer-reviewed review articles which cite primary clinical evidence
  • Reputable textbooks reporting human clinical data
  • Demonstration of food use (safety only)

With regards to evidence to support the weakest type of health claim, an antioxidant claim, the NHPD is proposing to accept in vivo animal studies using a validated model as stand alone evidence to support the efficacy of your product. This is beneficial as products which are safe, but do not have high quality efficacy evidence will be granted licenses, provided they contain recognized antioxidant ingredients.

In summary, weak evidence will support low risk claims for low risk products and strong evidence will support strong claims even with higher risk products, provided the Draft: Pathway for Licensing NHPs Making Modern Health Claims guidance document is approved.

Another proposed change outlined in this guidance document is the inclusion of traditional claims in a non-traditional PLA. The NHPD is proposing to allow traditional claims on non-traditional products, provided that the traditional claims are not the only claims present on the product label. Additionally, the label must include a non-traditional claim and the traditional claim must include the name of the ingredient and the traditional paradigm in which it has been traditionally used (e.g. Dandelion is traditionally used in Herbal Medicine as a diuretic). It is also important to note that traditional claims from more than one traditional healing paradigm can be present on a single non-traditional PLA – this may alleviate the issues that some applicants have been having when trying to make traditional claims from more than 1 paradigm.

Draft: Pathway for Licensing NHPs Used as Traditional Medicines

The criteria required for a traditional PLA has not changed drastically. The NHPD is proposing to require that all ingredients in a traditional product have evidence to support their use in a single traditional healing paradigm and that the traditional evidence to support the efficacy of the product be supported by evidence demonstrating that each of the herbs have been used in the same traditional healing paradigm for at least 50 consecutive years or 3 generations.

The NHPD is accepting comments on these draft guidance documents until August 21, 2012. Comments can be submitted to nhpd_consultations_dpsn@hc-sc.gc.ca.

For more information on the draft guidance documents, please visit the following links:

Draft: Pathway for Licensing NHPs Making Modern Health Claims – http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/natur/consult_modern-eng.pdf

Draft: Pathway for Licensing NHPs Used as Traditional Medicineshttp://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/natur/consult_tradit-eng.pdf.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com

dicentra Special Alert: Caffeinated Energy Drinks

Canada March 23, 2012

Special Alert – Caffeinated Energy Drinks

FOR IMMEDIATE RELEASE

As per previous communication from Health Canada, caffeinated energy drinks will no longer be considered NHPs. They are now deemed as foods and TMAs will have to be filed. TMAL (Temporary Marketing Authorization Letters) will be issued to those that meet the requirements.

The NHPD and Food Directorate sent out the Category Specific Guidance for Temporary Marketing Authorization for Caffeinated Energy Drinks to stakeholders this week. (see link below).

Energy Drinks – Category Guidance Document

The key points in the document are:

  • Definition of “Caffeinated energy drinks” has been clarified
  • Transition of submissions from NHPD to Food Directorate depends on which of the following categories the submission falls in
  • Timelines for transition depend on whether the submission has an NPN, EN, or submission number and are detailed in the document. Please note that all submissions filed after Oct 6, 2011 will be refused and will need to be re-filed as TMAs
  • Details of key dates to submit information with regards to the transition are also marked
  • Permissible Levels of caffeine and vitamins / minerals have been specified
  • Caution statements and guidance related to claims have been specified
  • There will be a requirement to undertake consumption incident reporting as a condition of their TMAs. Reports will need to be submitted to Health Canada annually.

For further information, We can be reached at 1-866-647-3279 or contact us

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, beverages, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com