Sunday, March 2, 2014

Dietary Supplements and Regulations

I'm posting this, because I care.  

Many of my personal training clients come to me asking which supplements (liquids, pills, powders, etc.) are the best.  In the past, I would have suggested a few 'dietary supplements' that I have used.  After listening to my body, working on several research papers, accessing several databases, and finding alarming results, my answer is that "I WILL NOT SUGGEST ANY SUPPLEMENTS".  They are not regulated any different than cosmetics!  If you lack energy, find your energy source through real foods.  We need a combination of carbohydrates, proteins, and fats.  These foods should hold their form, such as a vegetable or fruit from the earth, or a cut of meat that has been cooked with zero to little 'preservatives'.  Use spices and herbs to change the flavor.  Whatever happened to 'eat to live', not 'live to eat'?  Sure, I eat out up to four times each month.  That's four meals!  It's the behavior that makes the difference.  If you want to change the way you feel, whether it be about your body or your body's level of energy, you must change the way you think and the way you move your body. 

Journalism is what many people depend on for their information.  Whether it be through newspapers, magazines, television, or the internet, keep in mind that you are only viewing or hearing the opinions and statements the journalists want you to understand.  Take a look at the information below.  I have found the following information from the FDA's website.  This is copied, pasted, and YES, I have highlighted, in RED, areas that might catch the attention of those who do not want to spend the time to read.  Keep in mind that the FDA can only inspect so many supplements, due to funding. 

If you're still interested in reading more information, check out Consumer Reports September 2010 article "Dangerous supplements", pages 16-20. 

Put your health first.  Do your own research to make sure the "INSTANT GRATIFICATION" from your chosen supplement is not linked to what could be your future medical bills.  

In Health and Happiness,
~ Eve




Q&A on Dietary Supplements
NOTE: For information concerning DMAA (also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract), see Q & A on DMAA in Dietary Supplements.

General Questions:

Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:
  • a vitamin,
  • a mineral,
  • an herb or other botanical,
  • an amino acid,
  • a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
  • a concentrate, metabolite, constituent or extract.
A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.
In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.Also, manufacturers need to register themselves pursuant to the Bioterrorism Act with FDA before producing or selling supplements. In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products. These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.
The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994. For more detailed information, see new dietary ingredients.
FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a"Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.
Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients, if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors). For more details, see: Federal Register Final Rule - 62 FR 49826 September 23, 1997.
Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.
Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell. If you want more detailed information than the label tells you about a specific product, you may contact the manufacturer of that brand directly. The name and address of the manufacturer or distributor can be found on the label of the dietary supplement.
By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace. However, manufacturers and distributors of dietary supplements must record, investigate and forward to FDA any reports they receive of serious adverse events associated with the use of their products that are reported to them directly. FDA is able to evaluate these reports and any other adverse event information reported directly to us by healthcare providers or consumers to identify early signals that a product may present safety risks to consumers. You can find more information on reporting adverse events associated with the use of dietary supplements at Dietary Supplements - Adverse Event Reporting.
No, except for rules described above that govern "new dietary ingredients," there is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products. Likewise, there is no prohibition against them making this information available either to FDA or to their customers. It is up to each firm to set its own policy on disclosure of such information. For more information, see claims that can be made for dietary supplements
It is important to be well informed about products before purchasing them. Because it is often difficult to know what information is reliable and what is questionable, consumers may first want to contact the manufacturer about the product they intend to purchase (see previous question "Where can I get information about a specific dietary supplement?"). In addition, to help consumers in their search to be better informed, FDA is providing the following sites: Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information (includes information on how to evaluate research findings and health information on-line) and Claims That Can Be Made for Conventional Foods and Dietary Supplements, (provides information on what types of claims can be made for dietary supplements).
Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.
In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.
No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.
FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission.By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim, and are described in more detail.
This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.
The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to the FTC web site disclaimer icon. Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service.
If you think you have suffered a serious harmful effect or illness from a dietary supplement, the first thing you should do is contact or see your healthcare provider immediately. Then, you or your health care provider can report this by submitting a report through the Safety Reporting Portal. If you do not have access to the internet, you may submit a report by calling FDA's MedWatch hotline at 1-800-FDA-1088.
FDA would like to know when a dietary supplement causes a problem even if you are unsure the product caused the problem or even if you do not visit a doctor or clinic. Anyone may report a serious adverse event or illness thought to be related to a dietary supplement directly to FDA by accessing the SRP mentioned above.
Consumers are also encouraged to report instances of product problems using the Safety Reporting Portal . Examples of product problems are foreign objects in the packaging or other apparent quality defects.
In addition to communicating with FDA on-line or by phone, you may use the postage-paid MedWatch form available from the FDA Web site.
NOTE: The identity of the reporter and/or patient is kept confidential. For a general complaint or concern about food products, including dietary supplements, you may contact the consumer complaint coordinator at the local FDA District Office nearest you. See the following Web address for the telephone number: Consumer Complaint Coordinators15.


Reference:

Saturday, December 14, 2013

Test Anxiety

I more than passed my final! I owned it!


I had test anxiety leading into my final for college algebra.  Although determined, I was in a mode of second guessing my abilities.  How strange is it to be a person that motivates others, yet finds myself needing that very important piece?  I was concerned from Thursday, of the previous week, due to the snow and sleet precipitating during my drive to the school for tutoring.  Bound and determined, I made it to the school in an hour.  It normally takes fifteen minutes!  After only ninety minutes, I left as they were deciding to close the school down, due to weather and driving conditions worsening.  There was no opportunity to take advantage of tutoring throughout the weekend, due to the school being closed, and my daughter's school was closed until Wednesday.  I was overwhelmed with the fact that I could not receive tutoring.  Therefore, I pressed on to find YouTube videos and published assistance through the software that came with my math book.  

Test day arrived, and I was ready...or so I thought!  Ten minutes before class, I completely powered-off my phone to prepare for the test.  In my mind I told myself, “I'm doing pretty well for a student who started with a 65% and is currently at an 85%”.  Well, that was how I felt as I psyched myself into optimism through those last few minutes.  Five minutes before the test, my professor stated the test would last until 4:30.  Class is usually over by 3:45; I did not plan for 4:30.  I visualized a blinking alarm clock!  I thought, "I have a 4:15 client thirty minutes away from the school"!  I reached for my phone and powered-up.  As I typed the pass code, the little black dots remained absent, as if there were no entries.  Again, I typed the pass code.  Still nothing appeared in the passcode box.  Panic mode had set in!  I could not power the phone off!  The professor warned us, multiple times, that "If your phone goes off, rings, buzzes, or any distractions during the test, YOU GET AN F!"  NO!  I had no way of contacting my client about this time problem, and I could not turn my phone off.  Nearly one minute before the test, the power-off struggle was over; it worked.  It was completely turned off.  

As soon as I looked up, my college algebra professor was in front of me with the test sliding my way.  I'm always the last student to receive my test, and now the first?  Oh, how I thought this was a negative sign.  I took a deep breath in, picked up the pencil, and began to view my first problem.  I remembered Sequences and Series.  Now, why could I not solve such an easy problem?  I needed to figure the first four terms of this series, but it seemed like hieroglyphics.  It was as if I had never worked such a problem.  That was not a good sign.  I worked, then erased, and worked and erased, again.  What was I doing?  I decided to skip it and move to the next problem.  Well, I developed a severe case of anxiety.  As I worked problem two, I noticed the use of my eraser was inevitable.  Never had I used the eraser as much as I had used it that day.  It was not a comfortable feeling.  Instead of erasing, I've always drawn a line through my work and continued to work the problem.  

Nearly thirty minutes had gone by, before I turned the first of four pages over.  At that rate, I knew the two hour test was going to be a challenge.  “Breathe deeply”, I tell myself.  “You've got this.  You were confident while doing the homework.  You can do it.”  The rest of the test became fluid.  Halfway through the test, I have an odd solution to a variable that would be used to plug in to a formula.  This value was a fraction with a square root in the numerator.  Not one problem in any of my homework had any such solution.  I could not accept the radical in the numerator.  I chose to rework the problem after I finished the rest of the problems.  I found another fraction that was unusually small.  After a few attempts, with the same solution, I left the answer as I had solved it.  In the end, I returned to my ‘radical frenzy’.  Yes, it had a name.  I did not like it.  Can we not favor a math problem?  Sure we can!  I did not like this.  My decision was made.  Take it and move on.  

All answers were duplicated onto an answer sheet.  I gathered the four pages and answer sheet to deliver to my professor.  As I stood up to walk towards him, I realize that I was the last student in the class!  So, my next thought was that I must find out the solution to my radical in the numerator of a fraction problem.  Much to my surprise I was right!  Well, only for that variable!  Being completely fixated on the radical, I overlooked the actual problem and did not plug it in for the final solution!  We glanced over my answer sheet to see how I possibly did, without going over the entire test.  As far as the answers looked, he stated I had only three or four problems missed!  I was ecstatic!  Considering the struggles I had with the course, and having taken it a second time, I will succeed!  My professor was also head of the math department!  He asked if I were taking trigonometry next.  My reply, "No, but if I have extra time, I'd be up for a challenge.  My first priorities are to complete all prerequisites this spring!  I am applying for the radiologic technologist program."  He looked me straight in the eyes and said “I'd choose you”.  That meant so much coming from a department head who reminds me of the characters Spock, from Star Trek, and Sheldon, from The Big Bang Theory.  The anticipation of my test grade had weighed on me heavily, until last night.  I made an 89%!  I'll take that!  I am holding a solid B for the course!  I do not have to take it, again!

I wanted to ace this class.  It was my second time taking College Algebra.  I was not going to sink or fail, but I was also not happy with a D.  I visualized scoring and maintaining a B.  Through continued practice and accepting assistance in tutoring, I did succeed!  You can achieve whatever you set your mind to.  All you have to do is make that decision and make your dreams a reality!