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OTC Insomnia Supplements: The Latest Evidence – Medscape

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Dietary supplements are used by millions of people seeking a good night’s sleep, but which ones are safe and effective?


Response from Darren J. Hein, PharmD
Assistant Professor, Department of Pharmacy Practice; School of Pharmacy and Health Professions, Creighton University, Omaha, Nebraska

As many as half of all people experience sleep problems at some point in their lives,[1] and equal numbers say that they frequently use dietary supplements.[2] So it is really no surprise that questions about the use of dietary supplements for insomnia are routinely fielded by clinicians.[3]

Even though effective prescription drug products are available for the treatment of insomnia, for many patients, barriers to access (eg, cost of office visit and prescription), as well as the serious and sometimes bizarre side effects associated with the use of these prescription drugs, make turning to dietary supplements an attractive option. The American Academy of Sleep Medicine reviewed some of the more popular supplement sleep aids (melatonin, L-tryptophan, and valerian), ultimately recommending against all three in the most recent clinical practice guidelines.[4] It is vital that clinicians be informed about the safety and efficacy of these sleep aids to appropriately counsel patients.

Melatonin

Melatonin, one of the most popular dietary supplements, is widely believed to help patients fall asleep faster and without significant safety concerns. But does the available clinical evidence support that?

Most research to date has been of low to moderate quality, despite melatonin being commonly studied for the treatment of insomnia. Analyses of clinical trials suggest that it decreases the time it takes to fall asleep (sleep latency) by 5-9 minutes,[4,5,6] and that patients with delayed sleep phase syndrome seem to fall asleep even faster.[5] These results represent a statistically significant improvement compared with placebo; thus, the clinical impact of melatonin’s impact on sleep latency may be more profound when considering both the placebo effect and melatonin’s observed improvement over placebo. This is also where patient preferences and values should be taken into consideration. For some patients, falling asleep a few minutes faster might greatly improve both quality of sleep and quality of life; for others, not so much.

What risks are associated with melatonin? Most studies show that melatonin’s side-effect profile is comparable to placebo’s. Additionally, melatonin does not appear to cause hangover or withdrawal symptoms, which are often reported with prescription drugs. A recent systematic review of adverse effects related to melatonin use confirms that the supplement is generally benign. The most concerning adverse effects include fatigue and impaired cognitive and motor function, but these were primarily observed when patients took melatonin during daytime hours or prior to cognitive or neuromotor tests.[7] Patients who choose to use melatonin for sleep should be instructed to take it only before bedtime to avoid these unwanted effects.

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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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