Things You Should Know about E-Cigarettes

The FDA is taking more aggressive steps to reign in some aspects of e-cigarette marketing

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The FDA is taking more aggressive steps to rein in some aspects of e-cigarette marketing in its finalized rule, including a ban on sales to minors. The new regulations also require health warnings in ads and on product packages, prohibits the distribution of free samples, and requires manufacturers to show that the products meet applicable public health standards before receiving authorization from the FDA.

But e-cigarettes can continue to be on the market for three years while their manufacturers submit — and the FDA reviews — their new tobacco applications and the products are not bound by the same advertising restrictions that regular tobacco cigarettes must follow. In the meantime, use among teens is increasing even though the U.S. Surgeon General has called the products a significant health risk to youngsters. Here’s some key issues to be aware of regarding e-cigarette marketing:

Unknown risks: While much of the marketing of e-cigarettes has centered around the claim that vaping products are a safer alternative to tobacco cigarettes, the jury is still out on that. In fact, California issued a health warning about their “toxicity” and advised residents not to smoke them. The FDA maintains that the risks associated with e-cigarettes have not been fully studied. At issue is the nicotine in the products and the chemicals in the vapor that is emitted. Despite this health concerns, a review of more than 150 e-cigarette websites found that half indicate in some way that vaping products are safe or a healthy alternative to tobacco.


Moving Forward, Here’s What the FTC’s Order Requires Herbalife to Do

Kevin Thompson Shares His Legal Insight To The Herbalife Settlement

After a two year investigation, Herbalife has agreed to pay a $200 million fine to the FTC and act in accordance with prescribed measures. With this morning’s announcement of a settlement, investors and proponents/opponents of the MLM industry alike are attempting to process what it all means for the Company’s future. Before we provide you an in-depth analysis of the stipulations found within the FTC’s Order for a Permanent Injunction and Monetary Judgment, it’s important to remember that these prescribed actions only apply to Herbalife and not multi-level marketing companies collectively. In response to a question in which she was asked what kind of implications the settlement will have on the network marketing industry , FTC Chairwoman Edith Ramirez stayed mum on its long-term implications and stated rather plainly that the FTC would soon be providing additional guidance on legitimate network marketing companies. That aside, let’s get down to business and clarify what the FTC’s order does and does not say.


Macro Perspective


Injunction Stops Sale and Distribution of BioAnue Supplements

A federal judge has granted the Food & Drug Administration’s request

A federal judge has granted the Food & Drug Administration’s request for a permanent injunction prohibiting BioAnue from making and distributing its dietary supplement products until they comply with FDA regulations.

While BioAnue sold the products as dietary supplements, the FDA maintained that they were “unapproved new drugs” because they were marketed without FDA approval as treatments for a variety of diseases, including cancer, HIV/AIDS, heart disease and diabetes. In addition, BioAnue failed to follow the FDA’s current good manufacturing practice regulations for dietary supplements.

The products covered by the order include TumoRx Cardio Clean, TumoRx Apoptosis Full Strength, TumoRx Formula CX, BioAnue Diabetic Mender, BioAnue Heart Mender, Stroke Mender, Cardiovascular Mender and Bovine Cartilage. According to the FDA, BioAnue made therapeutic claims for the supplements, thereby establishing them as drugs intended for treating disease.

Claims made for Tumor X Cardio Clean, for example, included “Cardio Clean can …. [C]lean out your arteries and eliminate high cholesterol and triglycerides.” and “Cardio Clean … transforms artery clogging cholesterol into disease fighting substances needed for proper function inside the body.” In addition, the FDA maintained that the product name itself is an implied drug claim.

The FDA first issued a warning letter to BioAnue in February, 2012. A follow-up FDA inspection  the following August showed in addition to not taking action to correct the violations cited in the warning letter, the company also was not complying with the FDA’s current good manufacturing practice requirements for dietary supplements.


MLM Attorney Kevin Grimes Reports: Marshals Seize $2 Million in Dietary Supplements Containing from Hi-Tech Pharmaceuticals

U.S. Marshals in Norcross GA, acting at the request of the FDA, seized $2 million in dietary supplements from Hi-Tech Pharmaceuticals, Inc. According to the FDA, the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent.

DMAA is an unapproved food additive that is deemed unsafe and thus illegal under the Federal Food, Drug, and Cosmetic Act. In 2012, the FDA issued warning letters to companies telling them that products containing DMAA either needed to be removed from the market or reformulated without DMAA.

During inspections of Hi-Tech Pharmaceuticals that began last October, investigators found 11 products that were labeled as containing DMAA or its chemical equivalent, including Black Widow, ECA XTREME, FASTIN, FASTIN-XR, Lipodrene, Lipodrene HARDCORE, Lipodrene XR, Lipodrene XTREME, LIPOTHERM, Stimerex-ES, and YELLOW SCORPION. The investigators also found  bulk DMAA raw ingredients at the facility.

In total, more than 1,500 cases of finished product and more than 1,200 pounds of in-process and raw material goods were taken.

MLM Law Reports: FDA Takes Action Against Dietary Supplement Maker James G. Cole, Inc.

The Food and Drug Administration has filed a complaint seeking a permanent injunction against James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, to stop the company’s distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.

The complaint was filed by the U.S. Department of Justice in the U.S. District Court for the District of Oregon, Portland Division.

The injunction would stop the company from promoting and distributing its products until it complies with current good manufacturing practice (cGMP) requirements for dietary supplements, as well as remove all disease claims are removed from its websites, product labels and other products and websites under Cole’s custody and control.

The FDA says that  James G. Cole, Inc.‘s dietary supplements and other products have been marketed as treatments for cancer, heart disease, rheumatoid arthritis, autism, Alzheimer’s, fibromyalgia and high cholesterol. Under federal law, products offered for such uses are considered to be drugs, and none of those uses have been approved by the FDA.

The products include PCA, PCA-Rx, C-60, ACAI Resveratrol, Cytomune, Anavone, Liver Rescue, Probiotics and several other products. They are marketed under the Maxam Labs, Advanced Sports Nutrition and Maxam Nutraceutics brands.

In addition, during facilities inspections conducted in 2012 and 2013, the FDA found that James G. Cole Inc. distributed dietary supplements that were not manufactured in accordance with the cGMP requirements. For example, the company did not establish an identity specification for each component and did not conduct at least one appropriate test to verify the identity of a dietary ingredient.

MLM Law Reports: FTC Charges HCG Marketer with Deceptive Advertising

The FTC has filed a complaint against the marketers of the HCG Platinum dietary supplements, charging them with deceptive advertising for claiming that using the product will result in substantial weight loss.

The complaint filed in the U.S. District Court for the District of Arizona, names two corporate defendants, HCG Platinum, LLC and Right Way Nutrition, LLC, company president Kevin Wright, and seven relief defendants the FTC says received money from sales of the HGC products.

HCG, or human chorionic gonadotropin, is a hormone produced by the human placenta that the FTC says has, for decades, been falsely promoted by various marketers for weight loss. It is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions, but not for weight loss. According to this form of treatment has become more mainstream and is expected to remain a popular choice.

In 2011, Wright and six other HCG marketers received warning letters issued jointly by FDA and FTC staff, alerting them that were violating federal law by selling drugs that have not been approved by the FDA as well as by making unsupported claims for them.

According to the FTC complaint, the marketers made claims on the product packaging that the products cause consumers to lose a pound a day, are safe to use and are clinically proven to burn fat, reduce weight and lower cholesterol. Similar claims were made on Facebook and in Internet and magazine ads.

More than $13 million of HCG Platinum has been sold since 2010, according to the FTC, and the agency has asked the court to order the surrender of the gains.