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New lawsuit targets Prevagen, challenges claims that the supplement to improve memory – – KUSI

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SAN DIEGO (KUSI) – A popular supplement that claims to boost memory is the target of a new lawsuit. The supplement called Prevagen is sold in nearly every major retail store in the country, but critics say it’s worthless.

In advertisements on TV and online, the manufacturer of Prevagen says the product will support a “sharper mind,” “clearer thinking” and “healthy brain function.”

The product label says that clinical tests demonstrated some improvements in cognitive function in as little as 90 days.

However, the plaintiffs in a class action suit fled in Texas in late February said those claims are false, deceptive and designed to “dupe consumers ” into buying a supplement that has no effect on the brain.

Prevagen contains a synthetic protein called apoaequorin, modeled on a protein found in jellyfish.

Dr. Neal Devaraj, a biochemist at the University of California at San Diego said any protein taken orally would be broken down in the digestive process before it could reach the bloodstream. Since apoaequorin is a large water soluble protein, Deveraj said it could not possibly pass the barrier from the bloodstream into the brain.

Even though many may question the scientific basis for Prevagen’s claims, the manufacturer is still permitted to make its claims through its commercials, on the product package and on the bottle itself. Miro Copic, a professor of marketing at San Diego State University said that products marketed as dietary supplements face much less regulatory oversight.

“The dietary supplement space is kind of the ‘Wild, Wild West,’ ” Copic said. Unlike pharmaceutical drugs, Prevagen isn’t subject to review by the Food and Drug Administration.

The supplements are covered by a 1994 law that’s less protective of consumers.

In the stores we visited, we found that the product was nearly sold out. A bottle of the extra strength formula sells for $60 a bottle, for a 30 day supply.

Two years ago, the company that makes Prevagen was sued by the Federal Trade Commission. In its defense, Quincy Bioscience, based in Madison, Wisconsin argued that it had performed clinical trials to support its claims.

The FTC countered that the initial studies were inconclusive. However, the judge hearing the case ruled in Prevagen’s favor, after the supplement maker went back to the data, and selectively picked data subgroups to support its marketing claims.

While Prevagen prevailed in that 2017 case, last month a federal appeals court overturned the decision, setting the stage for the latest lawsuit. Copic said the suit poses challenges for the plaintiffs.

“You’re not being forced to buy this. It’s not a prescription.They’re making no claims that it will help you specifically. That’s why a lot of times, lawsuits in this arena are really hard to win,” Copic said.

Quincy Bioscience declined our request for an interview about the lawsuit.

A company spokesperson told us, “Nevertheless, we believe the claims are baseless and we will continue to fight these allegations on behalf of the millions of consumers who take Prevagen every day to improve their memory.”

The class action lawsuit filed several weeks ago is seeking reimbursement for the amount the class members spent on Prevagen and the difference between Prevagen and the market price of generic protein pills of a similar quantity and type.

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Collagen supplement use growing in popularity, improves skin, hair and nails – WXYZ

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There are so many options when a person goes into a supplement store, from vitamins to minerals and protein powders and more.

The latest one to grow in popularity? Collagen.

At Supplement Giant, owner Adam Watts says collagen powder is a popular product.

“Collagen is actually the most abundant amount of protein in our body,” Watts said.

Collagen represents 30 percent of a human body’s protein content.

“It’s found in animal bones ligaments and tendons again not traditionally part of our diet anymore,” he said.

Most brands sell collagen as a great supplement to take to improve a person’s hair, skin, fingernails, and bone and joint health.

“If you have a deficiency of collagen in your skin it can decrease you skin health which can cause stretch marks, dark spots, infections,” Watts said.

He suggests people age 30 and older take a collagen supplement.

“After the age of 30, collagen decreases by 1 percent, so by the time you’re 50, you’ve lost 20 percent of your collagen,” he said. “If you have injuries, collagen is going to help and repair tissue.”

Registered Dietician Jessica Crandall Snyder said she recommends food as medicine, not supplements.

“Being active on a daily basis you are actually helping to re-synthesize your collagen,” she said, “So supplemental sources from protein powders may not be the way for you to get adequate nutrition.”

While Adam Watts sells collagen powder at whole sale, other stores start the product at $25 per container.

But eggs, wild salmon, tomatoes, pumpkin and chia seeds are affordable foods that aid in collagen production.

The experts say collagen powder works, but make sure it’s not your main source of protein.

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CA Permit Sale of Hemp-Derived CBD in Foods & Supplements – The National Law Review

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California Assembly Bill 228 would expressly permit the retail sale of hemp-derived CBD in foods and supplements in California, notwithstanding the Food and Drug Administration’s position to the contrary. On Thursday, May 16, 2019, AB-228 passed through the State Assembly’s Appropriations Committee with a unanimous 18-0 approval. The Bill, sponsored by Assembly Member Cecilia Aguiar-Curry (District 4), moves to the House floor where a two thirds vote is required for it to continue on to the Senate for approval. 

AB-228 is intended to address the guidance offered by the California Department of Public Health (CDPH) in July 2018, which prohibits hemp-derived CBD from being added to foods. The CDPH’s release provides: 

California incorporates federal law regarding food additives, dietary use products, food labeling, and good manufacturing practices for food… Currently, the United States Food and Drug Administration (FDA) has concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which tetrahydrocannabinol (THC) or CBD has been added. This is regardless of the source of CBD – derived from industrial hemp or cannabis. 

While manufacturing and retail sales of marijuana-derived CBD products are permitted in accordance with California’s cannabis regulations, hemp-derived CBD remains unapproved for use as a food ingredient, food additive or dietary supplement. 

The City of Los Angeles took a similar position when its Department of Public Health, Environmental Health, which regulates food operators, issued the following guidance: “use of industrial hemp derived products in food will be considered adulterated and cited by DPH-EH as a violation resulting in a deduction of two (2) points on the official inspection report.” The Los Angeles guidance becomes effective on July 1, 2019. 

In response to the FDA’s position, California would join multiple states, including Colorado and Illinois, that have released policies allowing hemp-derived CBD in foods. AB-228 provides that “the sale of food or beverages that include hemp or cannabinoids, extracts, or derivatives from industrial hemp shall not be restricted or prohibited based solely on the inclusion of industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp. 

Though legalization at the state level does not preclude FDA enforcement, AB-228 would provide California defendants with an affirmative defense in civil court to unlawful adulterant allegations regarding CBD products. AB-228 also would allow hemp-derived CBD product sales by licensed cannabis businesses and declare that industrial hemp and its derivatives are an agricultural product. 

If the California House of Representatives passes AB-228, it will move on to the Senate where it must receive support by an assigned Senate committee before being placed on the Senate floor for a vote. If approved by the Senate, AB-228 will be delivered to Governor Newsom for final approval.

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Warning: Avoid dietary supplements from these 12 companies – ActionNewsJax.com

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In the quest to be healthy, dietary supplements continue to be a popular option with some people but the U.S. Food and Drug Administration’s recent warnings to companies hawking such products should cause potential customers to proceed with caution.

The agency recently sent out warnings to several companies that it said did not adhere to government guidelines on dietary supplement claims and their purported benefits.

FDA warns 12 companies over dietary supplement claims

Three of the companies ran afoul of the law by making claims about phenibut, which is sometimes marketed as a sleep aid. According to the FDA, phenibut does not meet the statutory definition of a dietary ingredient.

The FDA also issued nine warning letters to companies marketing DMHA (Dimethylhexylamine or 2-aminoisoheptane) as an ingredient in numerous dietary supplements.

In April 2019, the FDA determined that DMHA, which is often marketed for weight loss and sports performance, is either a “new dietary ingredient” for which the agency has yet to receive the mandatory New Dietary Ingredient notification or is “an unsafe food additive.”

The violations ultimately mean that American consumers may be buying and using products that are not approved for consumption. It also means the remedial claims of the products are as of yet unproven.

On the FDA’s website, a dietary supplement is defined as “a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.”

But then there is this major distinction: “Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as ‘reduces pain’ or ‘treats heart disease.’ Claims like these can only legitimately be made for drugs, not dietary supplements.”

Here are the FDA warning letters to the 12 companies

Warning Letters (DMHA):

Warning Letters (Phenibut):


Do you use dietary supplements? If so, do these warnings concern you at all? Let us know in the comments below!

The post Warning: Avoid dietary supplements from these 12 companies appeared first on Clark Howard.

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