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FDA Unveils List of Suspected Unlawful Ingredients in Dietary Supplements – The Pew Charitable Trusts

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The Food and Drug Administration unveiled a new effort last month to protect consumers from potentially unsafe dietary supplements that may contain unlawful ingredients. The Dietary Supplement Ingredient Advisory List, an online tool, alerts the public to chemical compounds that may not meet legal requirements for use in supplements.

Only substances that meet FDA’s definition of dietary ingredients can lawfully be included in supplements. But the process for making final determinations can take time, and consumers may unknowingly consume unlawful ingredients during that process. With the new list, FDA can flag suspect ingredients before a final decision.

Dietary supplements are regulated by FDA as a category of food. Supplement manufacturers—unlike drug companies—do not need to prove that a product is safe and effective before marketing it, but there are rules about which ingredients can be included in supplements.

Qualified ingredients can be vitamins, herbs, botanicals, or amino acids, among other substances. To be considered lawful, older ingredients must have been in the food supply when the law that governs FDA authority over supplements was enacted in October 1994 and they cannot be chemically altered. On the other hand, manufacturers of any product that contains a new dietary ingredient that was not in the food supply at that time must demonstrate a history of use or other evidence that the ingredient “will be reasonably expected to be safe,” according to FDA standards.

Housed on the FDA website, the new list can be used by consumers who do not want to buy dietary supplements containing questionable substances as well as manufacturers eager to avoid including these ingredients in their products. The Council for Responsible Nutrition, a dietary supplement industry group, supports the approach, issuing a statement characterizing the tool “as a clear warning to bad actors in the fringes of our industrythe regulators are coming for you if you attempt to skirt the law.”

Although some ingredients on the list have been shown to be potentially unsafe, such as a stimulant known as DMAA—a chemical associated with increased blood pressure and heart attacks—the agency says its decision to include an ingredient on the site does not necessarily indicate a safety problem. FDA says it will communicate separately and clearly any time it identifies safety concerns about specific dietary ingredients or supplements, and deploy other enforcement tools, such as safety warnings, when appropriate.

The new list is part of FDA’s ongoing effort to strengthen oversight of supplements and better protect consumers from unsafe products. The agency launched the initiative in February with an announcement that it is considering the most significant changes to its approach to supplements in 25 years. Because the list will be updated regularly, FDA encourages stakeholders to submit information that may support or refute preliminary assessments about various ingredients.

On May 16, the agency will hold a public meeting on how FDA can incentivize “responsible innovation” in the supplement market, the next step in its modernization effort. The Pew Charitable Trusts will be looking at any proposals offered through the lens of how they might affect safety.

In addition to implementing the new advisory list, FDA should continue to support legislation to institute a product listing requirement, under which manufacturers would have to share certain basic information about each product with the agency, such as its name, ingredients, and product label. This information would allow FDA to prioritize how it uses its resources, enabling it to take more effective, risk-based enforcement actions. If a possible safety problem with a dietary ingredient is identified and that ingredient is included on the advisory list, a comprehensive roster of supplements on the market would help FDA quickly identify other products that contain the same ingredient.

Sandra Eskin directs The Pew Charitable Trusts’ safe food project.

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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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