Supplements Midterm
section 201 of the FD&C Act defined drugs in part as
"articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals"
When was DSHEA enacted?
1994
Percent of US adults using 1,2,3,4, or more dietary supplements
20+: 13.8% used 4 or more DS 60+: 24.9% used 4 or more DS
Most common type of dietary supplements used by adults
20-39 age group (from most predominant to least) - MV with minerals, Vitamin D, omega 3 FA, and Botanicals 40-59 age group (from most predominant to least) - MV with minerals, Vitamin D, Omega 3 FA, Botanicals, Calcium 60+ age group (from most predominant to least) - MV with minerals, Vitamin D, Omega 3 FA, Calcium, and Vitamin B12
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: Interim Analysis
An operational and safety monitoring board (OSMB) within the Cleveland Clinic was established in April 2020 to provide safety monitoring and evaluate operational performance of all SARS-COV-2- related studies at the Cleveland Clinic Due to slower than expected enrollment, an interim analysis was conducted at approximately 40% of expected enrollment (214 of 520 patients). Stopping for superiority would only be considered if any treatment group achieved P < .001 compared with placebo. Stopping for Futility would be considered if the conditional power was less than 30 for any (or all) treatment groups compared with placebo
COMPARING PHARMACEUTICALS & DIETARY SUPPLEMENTS: Pharmaceuticals
Chemical can be natural or synthetically derived FDA regulates as drugs Requires regulatory (FDA) pre-market assessment of risk, efficacy Post-marketing surveillance (for adverse reactions) - This is also done for DS System is not perfect Some risks not identified until after marketing
What did NLEA allow the FDA to do?
Congress passed the Nutrition Labeling and Education Act (NLEA), which for the first time authorized FDA to permit certain well-supported "health claims" in food labeling. - FDA had historically permitted very few food claims regarding effects on structure and function, except for statements describing the recognized functional effects of vitamins and minerals: calcium builds strong bones or Vitamin A is essential for healthy vision, for example. DSHEA specifically authorized Statements of Nutritional Support (including structure/function claims).
A variety of factors associated with use of dietary supplements
Rising mistrust in conventional medicine and pharmaceutical drugs Higher demand and interest for alternative therapies Perception that "natural" is "healthy" and that plant products are safe Rising tendency for self-medication for increased control over one's own health
GRAS
generally recognized as safe
In addition, studies on SARS, a coronavirus, have shown that zinc can inhibit its....
ribonucleic acid polymerase
NDI requires
submission to FDA - Quite extensive; so many submissions to FDA
T/F: Eating a variety of foods each day can give you many of the vitamins and minerals you need for good health
true
Difference between a drug versus a supplement: Examples of Lipitor vs Cardio-Edge
1. LIPITOR - Statin - Drug to treat hyperlipidemia and high cholesterol - Regulated by FDA as a drug - Various doses (mg) 2. Cardio-Edge - Dietary Supplement - Also regulated by the FDA - Regulated as a food and is considered a natural product
MVMs - DELPHI consensus panel
1. MVMS can broadly improve micronutrient intakes - can be individualized according to age, sex, life-stage etc., 2. MVMs can ensure that adequate micronutrient needs are met to maintain health 3. Long-term use of MVMS not exceeding the upper intake limit is safe in healthy adults 4. Insufficient evidence to indicate that MVMS are effective for primary prevention of chronic medical conditions, including CVD and cancer
Most commonly used dietary supplements
1. Multivitamin-multiminerals (MVMs), most commonly used (32%) - To maintain health - To supplement the diet 2. Calcium-containing supplements (12%) - For bone health or healthy joints, or prevention of arthritis 3. Omega-3 fatty acids and fish oils (10%) - For heart health and lower cholesterol levels 4. Botanical supplements, multivitamins, Vit.E, Vit.B12, and protein-sports supplements - To improve overall health 5. Vit.B12 supplements: to enhance energy (25%)
Why is food considered a complex mixture?
1. Nutrients (macros and micros) 2. Non-nutrient substances (phytochemicals, botanicals, bioactive components) a. Frequently vital for plant or organism survival - Plant hormones - Naturally occurring pesticides b. Products of food preparation - Additives, coloring agents c. Natural and unavoidable contaminants - Products of microbial contamination - Products of environmental pollution d. Chemicals with pharmacological properties in animals, humans
What were the 2 primary goals of the DSHEA act?
1. to ensure continued consumer access to a wide variety of dietary supplements 2. to provide consumers with more information about the intended use of dietary supplements.
Why was the study called the COVID A to Z study?
A for Ascorbic Acid and Z for Zinc
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: Limitations
A major limitation was that there was no placebo control group; the current study was open label, and patients were not masked to which therapy they received. Also, stratification of symptoms by age, sex, race, or duration of symptoms prior to testing were not taken into consideration in the current analysis. - Furthermore, the doses of zinc and ascorbic acid, while well tolerated, could be lower than amounts needed to shorten the duration of symptoms, and patients could have previously taken supplements such as zinc and ascorbic acid before enrolling in the study.
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: Strengths
A major strength is the pragmatic design of the study and its novel primary end point, which was based on a symptom assessment questionnaire (time to reduction in symptom score by 50%).
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: Discussion
A significantly faster reduction in symptoms was not observed in any of the active treatment groups vs usual care. Based on an interim analysis, the study was stopped for futility. The data about oral ascorbic acid and zinc are inconsistent, with some trials suggesting that high doses of ascorbic acid and zinc gluconate may reduce the duration of common cold symptoms and decrease the severity of symptoms, while other studies have shown no benefit Ascorbic acid is known to be an antioxidant, and a variety of studies have suggested that it can affect the immune system. Moreover, in vitro and in vivo studies in avians have shown that ascorbic acid could be protective against coronavirus, and human trials have found that it may decrease susceptibility to viral respiratory infections and pneumonia High-dose zinc gluconate, ascorbic acid, or both supplements did not reduce SARS-CoV-2 symptoms
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: RESULTS
A total of 214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132 (61.7%) women. The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary end point. Patients who received usual care without supplementation achieved a 50% reduction in symptoms at a mean (SD) of 6.7 (4.4) days compared with 5.5 (3.7) days for the ascorbic acid group, 5.9 (4.9) days for the zinc gluconate group, and 5.5 (3.4) days for the group receiving both (overall P = .45). There was no significant difference in secondary outcomes among the treatment groups. - including number of days to reach no presence of fever, cough, shortness of breath, or fatigue.
What is a dietary supplement?
According to Dietary Supplement Health and Education Act (DSHEA) of 1994, a dietary supplement contains: - One or more vitamins - Minerals - Herbs or other botanicals - Amino acids, or other dietary ingredients (submitted for approval)
Trends in use of dietary supplements 2007-2008 to 2017-2018 - Broken up by age; Observe trends
All ages had an increasing trend in the past 10 years
Dietary Supplement Use among children and adolescents: Use and %
All ages: 33% of children and adolescents used a DS (1 or more) Ages: Less than 2 used a DS (1 or more) 2-5: 43% used a DS (1 or more) 6-11: 37% used a DS (1 or more) 12-19: 28% used a DS (1 or more)
a zinc metalloprotease that is important for cellular entry of coronavirus ...
Angiotensin-converting enzyme 2
COMPARING PHARMACEUTICALS & DIETARY SUPPLEMENTS: Dietary Supplements
Chemical is derived from foods or animal tissues - Generally, natural chemicals - Can also be synthetic FDA regulates as foods (not drugs) Pre-market assessment of risk (by FDA) is limited - Owners of the assessment of risk product safety is up to the manufacturer, not FDA No assessment of efficacy System is not perfect Some risks not identified until after marketing Some risks differ from pharmaceuticals
Dietary Supplement Use among children and adolescents
DS use is common among children and adolescents During 2014-2014, approximately one third of children and adolescents (persons aged 19 years or younger) in the US used a DS in the past 30 days Nutritional needs should generally be met thru food consumption - DS use can contribute substantially to over nutrient intake with the potential to mitigate shortfalls - DS use can lead to nutrient intake above recommended upper limits MV multimineral supplements were the most used DS
DSHEA and Label Claims
DSHEA ensured that consumers would be provided with more information about the intended use of dietary supplements by permitting a new category of label claims called Statements of Nutritional Support
What does DSHEA stand for?
Dietary Supplement Health and Education Act
What is the biggest difference between supplements and medications?
Dietary supplements in the US have been regulated as a category of foods. - In 1994, in enacting DSHEA, Congress again confirmed that this category of products would generally be considered foods. For example, if an orange or a Vitamin C supplement is described as a component of a healthy diet and a source of an essential nutrient, that is consistent with its use as a food. If the same product (Vitamin C) is labeled for use in preventing or curing the common cold, such labeling would indicate a drug use.
most common source of influence for student athletes to use DS
Doctor, coach
Primary reason for student athletes to use DS
Enhance sport performance, enhance well being, enhance mental performance
Has FDA banned dietary ingredients?
FDA has used the safety authority provided by DSHEA to ban some dietary ingredients, including ephedra, on the ground that they are not reasonably expected to be sage and the agency's determination has been upheld by the courts.
What does the FDA use for the basis of inspections of Dietary Supplements?
FDA is now using the new GMPs as the basis for inspections of DS manufacturers, and there have been many training courses offered to help companies ensure compliance. The new dietary supplement GMP regulation is an important step forward for ensuring the quality and reliability of DS.
T/F: It's safe to take a dietary supplement without your healthcare provider's approval
False
What does the term "GRAS" stand for in the context of dietary supplements?
Generally Recognized as Safe
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: CONCLUSIONS AND RELEVANCE
In this randomized clinical trial of ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms compared with standard of care
FDA is currently in the process of considering some major changes in nutrition labeling
It is possible that the dietary supplement format may point the way to future improvements in nutrition labeling for conventional foods. In particular, many functional foods now contain health-related ingredients that are not among the nutrients or components permitted to be listed in nutrition labeling. Some companies have taken the initiative of modifying the nutrition labeling format for conventional foods to include an "extension" below the vitamin/mineral list, where they list other components such as botanicals, omega-3 FA, and amino acids.
Why use dietary supplements?
Most common reasons: - Improve overall health (45%) - Maintain health (33%) Other reasons - Bone health (25%); more frequently among women (36%) than men (11%) - Supplement the diet (22%) - To prevent health problems (20%) - For heart health (15%) - To get more energy (11%) - Mental health (4%) - Prostate health in men (4%) - Weight loss (3%) - Menopause or hot flashes in women (2%)
NDI
New Dietary Ingredient (NDI)
1990: Congress passed the NLEA
Nutrition Labeling and Education Act
Introduction: Dietary Supplements
Over 50% of the population take at least one dietary supplement. In 1994, there were 4,000 dietary supplements In 2019, nearly 80,00 dietary supplements in the market $40 billion in sales
Overall: DSHEA law was enacted under the category of foods. Ingredients were grandfathered in but new ones past 1994 had to submit that ingredient to the FDA. The FDA would have the authority to pull any ingredient that they found unsafe.
Overall: DSHEA law was enacted under the category of foods. Ingredients were grandfathered in but new ones past 1994 had to submit that ingredient to the FDA. The FDA would have the authority to pull any ingredient that they found unsafe.
Dietary Supplement Usage
Overall: women are three times more likely than men to use one or more supplements Use increased with age Use was greater among non Hispanic whites than other racial groups and for those who have more than a high school education Academy of Nutrition and Dietetics revealed that adults were "two and a half times more likely" to use dietary supplements while taking prescription medication compared with adults without a medical condition
What other vitamin deficiency has shown to be associated with increased risk of COVID?
Recent studies have also demonstrated that vitamin D deficiency is associated with increased risk of SARS-CoV-2 infection and an increased risk of hospitalization, so the potential role of other supplements in decreasing SARS-CoV-2 symptoms cannot be concluded from our study.
Dietary supplements and ingredients in dietary supplements needed to be ...
Reported to the FDA after 1994 act DSHEA - Some dietary supplements and ingredients used in these supplements were grandfathered in without FDA notification.
The basic safety standard for food ingredients is established in...
Section 402 of the FD&C Act - which declares a food to be unsafe (Adulterated) if it contains a substance "which may render it injurious to health." Since dietary supplements are a category of foods, they are subject to this provision.
DSHEA was drafted in the offices of which senators?
Senator Orrin Hatch (R-UT) and Senator Tom Harkin (D-IA)
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID:
Serious Adverse Events The data safety monitoring board noted 4 serious adverse events, including 3 patients who died from COVID-19 and another patient who was admitted to the hospital for a chronic obstructive pulmonary disease exacerbation during the study period. The board did not believe that any of the adverse events were caused by individual treatments that patients received as a part of the study.
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: Methods
Sites include Ohio and Florida This study was approved by the Cleveland Clinic institutional review board and followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline. All patients participating in the study provided written informed consent. All study visits and/or procedures were conducted virtually, via telephone, email, computer, or laptop. Included if 18+ years Patients were excluded if they were hospitalized, resided outside of Ohio or Florida, were pregnant, were actively lactating, or had advanced chronic kidney disease, liver disease awaiting transplantation, or a history of calcium oxalate kidney stones. Race/ethnicity were self-reported.
Dietary supplement use among student athletes
Supplement use by high school and college students consisted of MV, stimulants, BCCAs/creatine/proteins, sports drinks, weight loss products, and others 53% of the study population were student athletes
Supplement users have higher intakes of what in contrast to non supplement users?
Supplement users have higher intakes of most vitamins and minerals from their food choices alone than nonusers
Structure/function claims:
Tens of thousands of letters of notification have been filed. FDA does not approve these claims, but does send the company a "courtesy letter" if a claim is not acceptable, and copies of the courtesy letters are available on the FDA website. It appears that about 10% of the letters of notification trigger a courtesy letter, indicating that approximately 90% are on target.
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: INTERVENTION
The 4 treatment strategies were as follows: (1) 8000 mg of ascorbic acid (to be divided over 2-3 times per day with meals), (2) 50 mg of zinc gluconate at bedtime, (3) both therapies, or (4) usual care without any study medications.
Commission on Dietary Supplement Labels
The Commission endorsed the FDA conclusion that the same standards should apply to both categories of claims. The Commission also addressed the need for adequate substantiation of Statements of Nutrition Support (structure/function claims), and these recommendations were referenced by FDA in establishing regulations for such claims. The Commission report also includes extensive discussion and guidance on dietary supplement safety, the appropriate regulation of botanical products intended for dietary supplement uses, as well as the needs to recognize appropriate drug uses of some botanicals, the need for more research on DS, and the role of the Office of DS at the National Institutes of Health (NIH).
DELPHI consensus panel
The Delphi technique is an established technique to answer a research question through the identification of a consensus view across subject experts. It allows for reflection among participants and reconsider their opinion based on the anonymous opinions of other - multiple opinions and try to arrive at a consensus
The Office of Dietary Supplements
The Office of Dietary Supplements working together within the 27 Institutes and Centers at NIH exercises a substantial influence on research support for dietary supplements and on the perception of such products by legislators, regulators, and the scientific community. It is and will remain an important legacy created by DSHEA.
Conclusions of MVMs with the DELPHI Consensus panel
The expert DELPHI consensus panel determined that MVMs can improve micronutrient intake among those with deficient and inadequate nutritional status, including some individuals with certain chronic medical conditions Healthcare providers should assess their patients' dietary patterns and consider intervening with MVMs for those at risk of inadequate nutritional status
The legislators who drafted DSHEA and the industry that supported DHSEA recognized the existence of problems with product quality and with Good Manufacturing Practices.
The legislators who drafted DSHEA and the industry that supported DHSEA recognized the existence of problems with product quality and with Good Manufacturing Practices. Accordingly, DSHEA specifically stated that DS would be considered misbranded if they failed to provide 100% of the claimed ingredients or if they failed to have the quality they were represented to have. In addition, DSHEA authorized FDA to develop Good Manufacturing Practice (GMP) regulations for DS, "modeled after current GMP regulations for foods" - Any dietary supplement today would have to follow these GMP
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: Outcomes
The primary endpoint was the number of days required to reach a 50% reduction in symptoms, including severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point scale for each symptom). Secondary end points included days required to reach a total symptom severity score of 0, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed medications, and adverse effects of the study supplements
DSHEA specified several conditions that must be met in order for structure/function claims to be used
The product may not claim to prevent or treat disease; the company using the claim must have substantiation for the statement; the company must notify FDA within 30 days that the claim is being made, and the label must bear a "disclaimer." The disclaimer is: This statement has two purposes. The first sentence is meant to distinguish structure/function claims from approved health claims, which are evaluated by the FDA. The second sentence is meant to distinguish structure/function claims from drug claims which do offer the product for disease prevention or treatment. Prevention or treatment of a disease comes under the category of drugs.
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: Treatment Design
The randomization grid was designed via the REDCap database and based on 25% of anticipated enrolled patients in each of the 4 groups. Patients were also asked to complete a questionnaire at the beginning of the study and every week after until day 28 to assess whether they were hospitalized or experienced adverse effects from the supplements. - For each symptom, the patients assigned a score of 0 to 3 (with 0 indicating no symptoms; 1, mild symptoms; 2, moderate symptoms; and 3, severe symptoms). Include a total of 12 symptoms (ie, fevers/chills, shortness of breath, cough, fatigue, muscle or body aches, headache, new loss of taste, new loss of smell, congestion or runny nose, nausea, vomiting, and diarrhea), creating a score ranging from 0 to 36 - Including all 12 symptoms x severe (3)=36 Patients were contacted by study coordinators weekly via email or daily via telephone to assess scores and hospitalizations, adverse effects, and additional medications.
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: DESIGN, SETTING, AND PARTICIPANTS
This multicenter, single health system randomized clinical factorial open-label trial enrolled 214 adult patients with a diagnosis of SARS-CoV-2 infection
FDA published the revised final rule on nutrition labeling for dietary supplements in 1997. This rule provides...
This rule provides for complete and meaningful information to be provided to consumers on the identity and quantity of all ingredients or components, except that proprietary blends may be quantified as such, without stating the quantity of each component. Example of proprietary: Curcumin (mixture of curcumoids) do not need to say the ratio.
A variety of purposes associated with use of dietary supplements
To balance the diet To compensate for the lack of nutrients or exercise or unhealthy lifestyle For health maintenance To prevent chronic diseases To improve appearance To improve wellness including mental conditions For sexual performance enhancement For sports performance enhancement
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: Objective
To examine whether high-dose zinc and/or high-dose ascorbic acid reduce the severity or duration of symptoms compared with usual care among ambulatory patients with SARS-CoV-2 infection.
What is the conclusion of the JAMA Network publication on the effect of high-dose zinc and ascorbic acid supplementation on symptom length and reduction in COVID-19 patients?
Treatment with high dose zinc or ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms with COVID-19
Was there a law for dietary supplements prior to 1994?
Up until 1994, there was no law for dietary supplements and the FDA was starting to engage in conversations about regulating dietary supplements. Senators brought this concern to congress and this idea of DHSEA was adopted.
Dietary supplements use among infants and toddlers
Using NHANES data (2007-2014) and trenders overtime (1999-2014). 18.2% of infants and toddlers used at least 1 DS over the past 30 days - Use of DS was lower in infants compared to toddlers
Most commonly used dietary supplements during Covid-19
Vitamin C (74.7%) Vitamin D (58.2%) MVMs (34.2%) Zinc (19.7%) Fish oil (17.9%) Probiotics (13.4%) Propolis (11.1%)
Under 12 months, most common DS were
Vitamin D and MV infant drops
Most common nutrients consumed as DS for those less than 2 years old
Vitamins D, A, C, and E for those less than 2 years old
Study with Effect of zinc and Vitamin C in decreasing symptoms or severity of COVID: Statistical Analysis
We assumed that the usual care group would achieve a 50% reduction in symptom severity in a mean (SD) of 6 (3) days and that at least 1 of the other 3 study groups would achieve a 50% reduction in a mean (SD) of 5 (3) days. Assuming a sample size in each of the 4 groups of 130 patients, a 1-way analysis of variance would have 80% power (2-sided α of .05) to detect a difference in means of 1 day with a common SD of 3 days The primary end point was defined as the number of days from the time of peak symptom score to a 50% resolution in those achieving a 50% reduction within the study time frame.
Dietary Supplement use among US Adults Overall Consensus
Women generally use more supplements than men; more use of DS came with age.
Which of the following is not considered a dietary supplement? a. A protein bar b. A liquid enzyme c. A chewable calcium supplement d. A vitamin C tablet
a. A protein bar
Which of the following is a correct statement about how dietary supplements are regulated? a. the FDA has to prove that the produce is unsafe in order to remove it from the market b. the FDA tests supplements for safety and efficacy before they hit the market c. the FDA is expected to guarantee the identity, purity, strength, and composition of dietary supplements
a. the FDA has to prove that the produce is unsafe in order to remove it from the market
According to DSHEA, new dietary supplement ingredients ("Dietary ingredients") can be marketed only...
after the manufacturer notifies FDA and submits information regarding the identity of the ingredient and the basis for concluding that it "will reasonably be expected to be safe"
Statements of Nutritional Support
allowing claims describing the effects of a nutrient or ingredient on the structure or function of the body.
What is the Dietary Supplement Health and Education Act (DHSEA) a. A law that requires dietary supplements to undergo rigorous clinical trials before being marketed b. A law that defines dietary supplements and sets labeling requirements c. a law that prohibits the sale of dietary supplements d. a law that restricts the use of certain ingredients in dietary supplements
b. A law that defines dietary supplements and sets labeling requirements
DS is intended to be taken
by mouth as a pill, capsule, tablet, powder, or liquid; - Is identified as such on the label
According to the NCHS Data Brief, what percentage of US adults (aged 20 and over) used any dietary supplement in the past 30 days in 2017-2018? a. 30-40% b. 40-50% c. 50-60% d. 60-70%
c. 50-60%
Which of the following statements about herbal supplements is true? a. Herbal supplements are always safe because they are natural b. herbal supplements are regulated by the FDA c. Herbal supplements can interact with prescription medications d. herbal supplements are not widely available
c. Herbal supplements can interact with prescription medications
Which of the following is a common type of dietary supplement used by all age groups? a. Vitamin D supplements b. Omega 3-fatty-acid supplements c. Multivitamin-multimineral supplements d. herbal supplements
c. Multivitamin-multimineral supplements
What is the purpose of the "Supplement Facts" panel on dietary supplement labels? a. to list potential side effects b. to provide information on the manufacturer's contact details c. To disclose the ingredients and their amounts d. To promote the product
c. To disclose the ingredients and their amounts
Which of the following statements about vitamin and mineral supplements is true? a. they are always necessary for optimal health b. they can replace a balanced diet c. excessive intake of certain vitamins and minerals can be harmful d. they are regulated as drugs by the FDA
c. excessive intake of certain vitamins and minerals can be harmful
Over 12 months, most common DS used were
chewable MV products
What motivates some patients to use dietary supplements? a. Cultural or traditional family beliefs b. Conviction that supplements promote a healthier lifestyle c. Belief that are supplements than pharmaceutical agents d. all of the above
d. all of the above
What is the primary reason dietary supplement users believe in taking supplements? a. to improve mental health b. to enhance physical health c. to prevent illness d. to cure existing health conditions e. all of the above
e. all of the above
Which of the following are guidelines to keep in mind choosing a dietary supplement? a. Check with your healthcare provider about the supplement b. be mindful of product claims c. Look for third-partying testing, for example a USP label, on the dietary supplement d. don't let nutrient levels exceed the upper intake level e. all of the above
e. all of the above
The US Centers for Disease Control and Prevention (CDC) list of SARS-CoV-2 symptoms includes
fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea.
In terms of biologic plausibility, zinc is known to play a role in
immune function via antibody and white blood cell production. Zinc supplementation has been suggested to increase polymorphonuclear cells' ability to fight infection, while there is evidence that zinc deficiency increases pro-inflammatory cytokines and decreases the production of antibodies. - Zinc has also been implicated in coronavirus biology.
In 1941, the Food and Drug Administration (FDA) promulgated regulations defining special dietary uses to ...
include many specific functions, one of which is "supplying a vitamin, mineral or other ingredient for use by man to supplement his diet by increasing the total dietary intake" These supplements are meant to supplement the diet.
DSHEA specifies that a dietary supplement is considered unsafe (Adulterated) if ...
it "presents a significant or unreasonable risk of illness or injury" under the conditions of use suggested in labeling or under ordinary conditions of use.
Use of dietary supplements is associated with ....
lower BMIs, moderate alcohol use, more exercise, abstinence from smoking, and having health insurance
FDA no longer officially reviews and approves GRAS petitions, but instead ...
permits companies to conduct their own GRAS determinations for food ingredients, with or without notifying the agency of their actions. - If the agency is notified, the ingredient appears on a list on the FDA website, but if the company chooses not to submit a notification, the ingredient does not appear on the list. - Therefore, there is no authoritative list of all GRAS ingredients of food.
COVID-19 and dietary supplement use In America, Asia, Europe, and turkey
supplement use increased among all during the pandemic
DSHEA was drafted in the offices of Senator Orrin Hatch (R-UT) and Senator Tom Harkin (D-IA) to ensure ...
the continued availability of a wide variety of dietary supplements by establishing a definition of dietary supplements within the FD&C Act, specifying the categories of ingredients that were to be permitted - vitamins and minerals, amino acids (BCAAs), herbs or botanicals (curcumin), and other components of food, plus any combination of ingredients. - This meant that supplements could be bought at any store without a prescription, OTC and under the category of foods.
The notification system for NDIs is in some ways similar to ...
the notification system for food ingredients that are GRAS
Zinc gluconate and ascorbic acid are commonly taken for the treatment of
viral illnesses. - Zinc has been purported to increase polymorphonuclear cells' ability to fight infection - Ascorbic acid is an antioxidant that may play a role in immune response.
