FDA warns Popsalot, LLC that its Moroccan Mystique gourmet flavored popcorn product was falsely advertised as gluten free

Popsalot

On June 21, 2016, the FDA sent Popsalot, LLC a warning letter stating that its “Moroccan Mystique” gourmet flavored popcorn product is misbranded and its labeling false or misleading because the product bears the claim “gluten-free” but fails to comply with the definition of “gluten-free” [21 CPR 101.91(a)]. The FDA analyzed the product and found greater than 20 ppm gluten. According to regulations, the unavoidable presence of gluten in the food that bears a gluten-free claim must be below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim “gluten-free” in its labeling and fails to meet this requirement will be deemed misbranded.

Quaker Oats (PepsiCo) and others accused of mislabeling products by Maple Syrup Producers’ Associations — Investigation opened

Quaker Oats

A consortium of Maple associations asked the FDA to take enforcement actions against a variety of companies that use the terms maple but whose product does not contain any. This misbranded group of products generally declares “maple” on their packaging as a characterizing ingredient even where maple syrup is not actually present in the product.

As claimed by the association, the term “maple” has long been used and understood to refer to “maple syrup.” Maple syrup, a premium ingredient, has a material bearing on the price and/or consumer acceptance of food products that contain it, which is why it is frequently an ingredient named in the title properly labeled to prevent consumer confusion.

As further claimed by the Associations, this unchecked misbranding has an adverse impact on manufacturers of products containing real maple syrup, as it allows cheaper products not containing premium ingredients to compete with those actually containing maple syrup. Further, it deceives consumers into believing they are purchasing a premium product when, in fact, they have a product of substantially lower quality.

The letter requests the FDA take enforcement actions to stop the misbranding of this class of products, either by removing the maple branding from the packaging, or by adding maple syrup – a substance derived from the heat treatment of sap from the maple tree of foods or displayed on its packaging. Thus, if a product name includes “maple,” or its packaging emphasizes the presence of maple (e.g., through vignettes of maple syrup, leaves, and trees), but the product does not actually contain any maple syrup, it is unlawfully misbranded under this regulation.

The letter called out the following products as using the term maple without having maple as an ingredient.

MOM Brands’ Better Oats Maple & Brown Sugar Instant Oatmeal with Flax

Madhava Natural Sweeteners Maple Agave Nectar

Honey Stinger Organic Maple Waffle

Quaker Oats Maple & Brown Sugar Instant Oatmeal

Quaker Oats Maple & Brown Sugar High Fiber Instant Oatmeal

GU Maple Bacon Energy Gel

Quaker Oats Maple Pecan Raisin Flavored Oatmeal

Hood Ice Cream Maple Walnut

 

Have you consumed any of these products? Have you consumed other products labeled as containing maple only to find out it contained none?  Please share your story with us or contact us directly to inquire about your legal rights.

 

 

FDA Warns Kind LLC about mislabeling and misbranding their products with unsupported nutrient content claims

The FDA sent a letter warning Kind LLC, the maker of a variety of bars, that their Kind Fruit & Nut Almond & Apricot, Kind Fruit & Nut Almond & Coconut, Kind Plus Peanut Butter Dark Chocolate + Protein, and Kind Plus Dark Chocolate Cherry Cashew + Antioxidants products are misbranded under the Federal Food, Drug, and Cosmetic Act (“FDCA”) as improper implied nutrient content claims, because they bear statements suggesting that the product may be useful in maintaining healthy dietary practices, and those statements are made in connection with claims or statements about nutrients.

According to the FDCA, a manufacturer may use the term “healthy” as an implied nutrient content claim on the label of a food provided that the food, among other things, is “low saturated fat”[i.e., the food has a saturated fat content of 1 g or less and no more than 15 percent of the calories are from saturated fat].

The FDA bars found the following products did not meet this standard.

Kind Fruit & Nut Almond & Apricot which contains 3.5 g of saturated fat per 40 g

Kind Fruit & Nut Almond & Coconut product which contains 5 g of saturated fat per 40 g

Kind Plus Peanut Butter Dark Chocolate + Protein product contains 3.5 g of saturated fat per 40 g

Kind Fruit & Nut Dark Chocolate Cherry Cashew + Antioxidants contains 2.5 g of saturated fat per 40 g

The FDA also found Kind’s use of  the phrase “antioxidant-rich” and “good source of fiber” in violation of the FDCA labeling requirements.

 

Accurate labeling matters.  If you were misled by the labeling on this product or any others, we want to hear from you. Please share your story with community and/or directly with us via the contact a lawyer box below.  

FDA finds many dark chocolates contain milk and do not disclose it to consumers

The FDA tested 100 dark chocolate products and found that many contained milk. Most importantly consumers could not tell about the inclusion of milk by reading the food label.

Milk is one of eight major food allergens (the others are wheat, eggs, peanuts, tree nuts, fish, Crustacean shellfish and soybeans). U.S. law requires foods containing a major food allergen to provide its name—in this case, milk—on the label. This is one of the ways to help ensure consumers know what’s in the food they’re eating. Undeclared (not listed on the label) allergens are a leading cause of food recall requests by the FDA.

A manufacturer may not intend to use milk in a dark chocolate product but if the dark chocolate product shares equipment with, for example, a milk chocolate product, traces of milk may inadvertently wind up in the dark chocolate. After hearing from consumers who had eaten dark chocolate and experienced harmful reactions, FDA tested 100 dark chocolate bars for the presence of undeclared milk. The selected bars were obtained from different parts of the U.S. and each bar was unique in terms of product line and/or manufacturer.

What the FDA Study Found

•While dark chocolates labeled “dairy free or allergen-free” were the least likely to contain milk, two out of 17 of these products were found to contain milk.

•All seven bars that declared the presence of milk on the label contained milk; however, 55 (59%) of 93 bars without any clear indication of the presence of milk also were found to contain milk.

•Six out of the eleven chocolate products labeled “traces of milk” contained milk at detectable levels high enough to potentially cause severe reactions in some individuals.

The FDA warns consumers who are allergic to milk should be aware that a high proportion of tested dark chocolates contained milk. “

Consumers can find out what products have been recalled recently at FDA’s website and at the Food Allergy Research and Education website.

http://www.fda.gov/ForConsumers/ConsumerUpdates

 

USPLabs, LLC And General Nutrition Center named in class action lawsuit over deceptive marketing of OxyElite Pro

USPLabs sells a variety of energy and weight loss dietary supplements under the brand name of OxyElite Pro™ through GNC, which are dangerous, sold pursuant to deceptive and unfair practices, and not fit for their intended purpose.

The Product is intended to safely provide weight loss, energy, and mental focus. However, it instead causes severe adverse health effects. Plaintiff, and all other similarly situated consumers, did not bargain for a Product that causes adverse health effects in exchange for their payment of the purchase price.

According to the complaint, several adverse reactions have been reported from consumers who have purchased and ingested the Product, including, but not limited to serious liver injury wrongful death.

USPLabs and GNC had and has actual knowledge of the Product’s shortcomings but failed to timely act to adequately warn consumers of: the unfitness of the Product; the extreme adverse side effects associated with the Product; or provide adequate relief to the putative Class of consumers who purchased the Product.

Plaintiff alleges that the Product does not work as impliedly warranted and as a result, misleads consumers into purchasing it.

Class: All United States persons who, within the applicable statute of limitations, purchased the Product, for personal use and not resale, through and to the date Notice is provided to the Class.

Living Harvest named in class action over products containing evaporate cane juice

Living Harvest advertises and markets many of its Products as having evaporated cane juice, an unlawful term that is merely a false and misleading name for another less healthy food or ingredient that has a common or usual name, namely sugar. By using the term evaporated cane juice, Living Harvest is concealing the fact that it is adding sugar to its Products.

According to the complaint, Living Harvest engaged in a uniform campaign through which it purposefully misrepresented and continues to purposefully misrepresent to consumers that its Products contain ECJ even though “evaporated cane juice” is not “juice” at all—it is nothing more than sugar, cleverly disguised. Defendant conceals the fact that its Products have added sugar by referring to the sugar as ECJ, a “healthy” sounding name made up by the sugar industry years ago to sell sugar to “healthy” food manufacturers for use in their consumer products. ECJ is not the common or usual name of any type of sweetener, or even any type of juice, and the use of such a name is false and misleading. Living Harvest uniformly lists ECJ as an ingredient on its Products, as well as on its website and other promotional material.

Class: Plaintiff brings this consumer class action on behalf of herself and all other persons who, from October 22, 2009 up to and including the present (the “Class Period”), purchased in Florida for consumption Products listing Evaporated Cane Juice (“ECJ”) in the ingredients

The lawsuit and those similar naming other product that contain evaporated cane juice are based, in part, on FDA industry guidance which advised that:

[T]he term “evaporated cane juice” has started to appear as an ingredient on food labels, most commonly to declare the presence of sweeteners derived from sugar cane syrup. However, FDA’s current policy is that sweeteners derived from sugar cane syrup should not be declared as “evaporated cane juice” because that term falsely suggests that the sweeteners are juice…

“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.” … 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)). The common or usual name must accurately describe the basic nature of the food or its characterizing properties or ingredients, 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 with common or usual names defined by regulation are sugar (21 CFR 101.4(b)(20)) and cane sirup (alternatively spelled “syrup”) (21 CFR 168.130). Other sugar cane products have common or usual names established by common usage (e.g., molasses, raw sugar, brown sugar, turbinado sugar, muscovado sugar, and demerara sugar)…

The intent of this draft guidance is to advise the regulated industry of FDA’s view that the term “evaporated cane juice” is not the common or usual name of any type of sweetener, including dried cane syrup. Because cane syrup has a standard of identity defined by regulation in 21 CFR 168.130, the common or usual name for the solid or dried form of cane syrup is “dried cane syrup.”…Sweeteners derived from sugar cane syrup should not be listed in the ingredient declaration by names which suggest that the ingredients are juice, such as “evaporated cane juice.” FDA considers such representations to be false and misleading under section 403(a)(1) of the Act (21 U.S.C. 343(a)(1)) because they fail to reveal 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. Furthermore, sweeteners derived from sugar cane syrup are not juice and 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).

Homeolab USA Inc. warned by FDA over mislabeling and marketing of Kids Relief Earache.

The letter advised that the United States Food and Drug Administration (FDA) reviewed Homeolab’s labeling and marketing information for the drug product, “Kids Relief Earache” and found it to be in violation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

 

The flase and misleading representations include:

“Ferrum phosphoricum 30X……inflammation and fever”

“Belladonna 30X……throbbing pain and inflammation

“Pyrogenium 30X……infection and fever”

“Relieve mild to severe ear pain”

“Soothe throbbing pain & pressure”

“Reduce Inflammation”

Based on these claims, the product is a drug as defined by section 201(g)(1)(B) and (C) of the FD&C Act [21 U.S.C. § 321(g)(1)(B) and (C)], because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and/or intended to affect the structure or any function of the body.

Although marketed to consumers as an over-the-counter (OTC) drug, Kids Relief Earache is a prescription drug under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. Section 503(b)(1) of the FD&C Act [21 U.S.C. 353 (b)(1)] identifies criteria for determining the prescription status of a product. The product listed above is a prescription drug within the meaning of section 503(b)(1) of the FD&C Act because it is intended to treat diseases that require diagnosis and treatment by a physician or is intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Ear pain (earache) is not a currently recognized OTC indication in any final monograph or in any approved OTC new drug application.  OTC treatment is inappropriate for ear pain because consumers cannot distinguish its symptoms from those of more serious disorders of the ear or adjacent tissues which are not amenable to OTC treatment and which can lead to serious injury if not accurately diagnosed and treated by a licensed healthcare professional.

Because this product is subject to 503(b)(1) of the FD&C Act, the product is misbranded under section 503(b)(4) of the FD&C Act [21 U.S.C. § 353(b)(4)] in that the label fails to bear the symbol, “Rx only.”

Kids Relief Earache is also misbranded within the meaning of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352 (f)(1)] in that its labeling fails to bear adequate directions for use as that term is defined in 21 C.F.R. § 201.5. The indication for which the product listed above is labeled and marketed, i.e., treatment of ear pain or inflammation, is not appropriate for OTC use. If an indication requires the supervision of a practitioner licensed to prescribe drugs, adequate directions for use cannot be written for an OTC drug product for that indication.

The FDA also found the drug misbranded within the meaning of section 502(a) of the FD&C Act [21 U.S.C. 352 (a)] in that its labeling is false or misleading because it represents the product as suitable for use by consumers to treat a condition which the Agency has found not appropriate for OTC drug treatment, and because it encourages OTC treatment for ear pain, but fails to distinguish among conditions that manifest with ear pain and that can lead to serious injury if not accurately diagnosed and treated by a licensed physician.

Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.  The FDA acknowledged that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed. Thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with section 503(b) of the FD&C Act. Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed over-the-counter (OTC). Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.

The FDA ordered the company to take prompt action to correct the violations cited in the letter.

FDA Investigates Safety of Added Caffeine to Variety of Products

The U.S. Food and Drug Administration announced that it will reexamine the safety of caffeine added to foods.  The decision was prompted by the release of a new caffeinated gum called Alert, manufactured by Wrigley, which hit markets Monday.

The last time FDA looked at caffeine as a food additive was in the 1950s when the agency set a limit on the amount of the substance that could be added to colas. Caffeine is on the agency’s list of ingredients that are  ”generally recognized as safe” (GRAS) when it comprises .02 percent of a cola beverage, but has not been regulated in other contexts.

Energy drinks are often exempt from the .02 percent limit because they are considered dietary supplements rather than food or drink.

Between 2004 and 2012, five people died after consuming Monster drinks, according to data from FDA. During this time period, 21 people experienced “adverse effects” after drinking Red Bull, although no deaths were reported.  In Canada, three deaths were reported after the consumption of Red Bull between 2003 and 2012.

Because so many artificially caffeinated food and drinks have hit the market since the time FDA considered caffeine in cola, FDA is taking a fresh look at the potential impact that the totality of new and easy sources of caffeine may have on the health of children and adolescents.

L’Oreal USA, Inc. named in class action over allegedly false advertising of its Lancôme cosmetic products

This is a class action on behalf of residents of California against Defendants for misleading consumers through the labeling, marketing, and advertising of Lancôme cosmetic products, including its Génifique, Renergie Lift Volumetry, Absolue Precious Cells, Visionnaire, and High Resolution line of products (collectively, “anti-aging cosmetic products.

The class consists of those California residents who purchased the above named Lancôme cosmetic products from November 5, 2008 to the present (the “Class Period”).

As alleged in the complaint, Lancôme engaged in deceptive acts and misrepresentations concerning the Company’s anti-aging cosmetic products which have injured Plaintiffs and the Class.

During the Class Period, Lancôme labeled, advertised, marketed, and sold its anti-aging cosmetic products using language that led reasonable consumers to believe the products could prevent, reduce, or reverse the signs of aging, including by manipulating biological structures. As detailed more fully herein, Lancôme claimed its products would affect the structure of the human body in several ways, including boosting the activity of genes, stimulating production of youth proteins, improving the condition around stem cells, and stimulating cell regeneration in order to retard or reverse the signs of aging.

On September 7, 2012, the United States Department of Health and Human Services, United States Food and Drug Administration (“FDA”) issued a Warning Letter to Lancôme.1 In the Warning Letter, the FDA alleged that Lancôme was marketing the anti-aging cosmetic products complained of herein as new drugs, in violation of FDA regulations.

In sum, the Warning Letter stated that if Lancôme’s anti-aging cosmetic products do what Lancôme claimed, the products “affect the structure” of the human body. According to the FDA, this property would render the products drugs. However, Lancôme does not have approval to market any of its products as drugs. Lacking such approval, the FDA classified Defendants’ products as unapproved new drugs. Marketing new drugs without FDA approval is illegal under the federal Food, Drug, and Cosmetic Act (“FDCA”).

As alleged, Lancôme engaged in pervasive deceptive labeling and advertising of its anti-aging cosmetic products. Lancôme intended to and did induce Plaintiffs and the Class collectively to spend millions of dollars on the Company’s anti-aging cosmetic products based on the belief that the products would perform as represented by Lancôme.

Lancôme developed its advertising scheme to grow the Company’s sales of its anti-aging cosmetic products based on deliberate misrepresentations of the products’ actual properties. Lancôme knew that consumers concerned about signs of aging would pay a considerable markup for products that claimed to slow or reverse those signs rather than simply mask them. Accordingly, Lancôme charged distributors a sizeable premium for these products.

If Plaintiffs and the Class had been aware of the truth, they would not have purchased the Lancôme anti-aging cosmetic products and/or would not have paid a premium price.

Plaintiffs seek an order compelling Lancôme to: (1) restore to Plaintiffs and the Class the amounts by which they were injured, (2) destroy all misleading and deceptive materials and products, or re-label them with language to correct the confusion complained of herein, and (3) conduct a corrective advertising campaign informing consumers that the products were formerly advertised to have properties that they do not have, specifically identifying each such property.

FDA Warns That Mirapex May Increase Risk of Heart Failure

FDA has alerted health care professionals to the possibility that the medication Mirapex (pramipexole) could increase the risk of heart failure. Mirapex is a prescription medicine used to treat the signs and symptoms of Parkinson’s disease and restless legs syndrome.  It is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.

Risk: FDA evaluated an analysis of clinical trials and found that heart failure was more frequent with Mirapex than with a placebo treatment. However, these results were not considered statistically significant. FDA also evaluated two epidemiologic studies that suggested an increased risk of heart failure with Mirapex use. However, study limitations made it difficult to determine the influence of other factors.

Thus FDA has not been able to determine conclusively whether Mirapex increases the risk of heart failure. The agency is working with the manufacturer to clarify the risk and will update the public when more information is available.

At this time, FDA has not concluded that Mirapex increases the risk of heart failure.

The FDA suggests that patients should contact their health care professional if they experience any symptoms of heart failure, such as shortness of breath, swelling of the feet, ankles, legs, or abdomen, fatigue and weakness, rapid or irregular heart beat, chest pain, or persistent cough or wheezing with white or pink blood-tinged phlegm.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm325508.htm