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Supplement Sellers Beware – Lexology

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Recognizing the rapid growth and penetration of dietary supplements into all demographics of American consumers, the Food and Drug Administration (FDA) is viewing at least some dietary supplements as belonging to “the Wild West,” and intends to be Wyatt Earp. Or supplements are the Wild Wild West and the FDA is Will Smith, if that’s your thing. Recently, the agency announced an initiative to increase regulation of dietary supplements, reacting to what it describes as “the growth in the number of adulterated and misbranded products” on the market. At the same time, the agency was careful to say that “most players in this industry act responsibly.” Adding bite to its bark, the FDA took action the same day it made this statement, issuing 12 warning letters and five online advisory letters to offending companies. The enforcement effort specifically targeted dietary supplements that make unlawful drug claims related to treating Alzheimer’s and other diseases.

The issue is clearly of importance to the federal government, as the Federal Trade Commission (FTC) joined the FDA in three of these warning letters. For example, the agencies sent a joint warning letter to Gold Crown Natural Products concerning claims made in relation to its supplements, including this one: “Many experiments have been conducted on this and it is proven that melatonin supplements are used to cure Alzheimer’s disease.” The FDA was primarily concerned with this and other companies making disease claims when they don’t have the necessary prior approval from the agency to do so. Such claims make the product an illegal drug. Similarly, the FTC warned that competent and reliable scientific evidence supported by well-controlled human clinical studies is necessary for advertisements that a product can treat a disease. These letters are part of an ongoing effort by both agencies to target deceptive claims aimed at an increasingly aging population.

Ultimately, this increased scrutiny from the FDA and FTC could be beneficial to the dietary supplements industry. If supplements making unsubstantiated claims are weeded out by a visibly active FDA, then the consuming public will have more faith in the products on the market. In the short term, however, supplement makers need to check that their products are compliant with relevant law, particularly with respect to any drug claims.

In its statement, the FDA also announced five additional steps:

  1. The agency will implement a “new rapid-response tool” that will alert both the public and industry to the agency’s concerns that an ingredient is unlawful.
  2. The agency will update the process for its new dietary ingredient (NDI) notifications. In its statement, the FDA noted that this is its only opportunity to evaluate new ingredients before a product reaches consumers, and to aid that effort it will be revising its compliance policy for NDIs. The agency will accept feedback on this issue in a public meeting, the details of which are not yet available.
  3. The agency will seek to partner with industry on important issues and has announced the creation of the Botanical Safety Consortium, a public-private partnership focusing on botanical ingredients and their use in dietary supplements.
  4. The agency will continue to take enforcement action. The statement specifically notes that supplements with unlawful ingredients, such as drug ingredients, are a point of emphasis.
  5. The agency will publicly engage with stakeholders on how to “modernize” the Dietary Supplement Health and Education Act. Dietary supplement exclusivity and a mandatory product listing requirement are specifically referenced.

The FDA’s statement noted that there will be more changes coming, on which we will keep you informed. It remains to be seen, however, whether the recent resignation of Commissioner Gottlieb will slow down any of these initiatives. For now, it’s important to note that both the FDA and the FTC are signaling that they intend to be significantly more active in regulating dietary supplements, particularly with respect to drug claims.

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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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