Daily Archives: June 21, 2017

Photo: Contributed / Contributed

FDA urges caution about bodybuilding supplements

Its beach season and, while some might turn to bodybuilding supplements to get their body sand-and-sun-ready, experts said not all of these products are safe.

According to a consumer safety release from U.S. Food and Drug Administration, bodybuilding products that contain steroids or steroid-like substances are associated with potentially serious health risks, including liver injury. Some of the liver injuries were life-threatening, said Mark S. Miller, FDA regulatory review officer, in the statement.

In addition to liver injury, anabolic steroids have been associated with serious reactions such as severe acne, hair loss, altered mood, irritability, increased aggression, and depression. They have also been associated with life-threatening reactions such as kidney damage, heart attack, stroke, pulmonary embolism (blood clots in the lungs), and deep vein thrombosis (blood clots that occur in veins deep in the body).

These bodybuilding products are promoted as hormone products and/or as alternatives to anabolic steroids for increasing muscle mass and strength. Many of these products make claims about the ability of the active ingredients to enhance or diminish androgen, estrogen, or progestin-like effects in the body, but actually contain anabolic steroids or steroid-like substances, synthetic hormones related to the male hormone testosterone.

Some who use bodybuilding products engage in stacking, using multiple products (including stimulants or products providing false assurances of liver protection) to enhance results or gains. These combinations may put consumers at greater risk for serious and life-threatening reactions.

If youre taking any body building products that claim to contain steroids or steroid-like substances, the FDA recommends that you stop taking them immediately because of the potentially serious health risks associated with using them. The agency also recommends that you talk to your health care professional about any body building products and/or ingredients you have taken or are planning to take, particularly if you are uncertain about those ingredients. You should also talk to your health care professional if you are experiencing symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes), or brown or discolored urine.

The FDA encourages consumers and health care professionals to report adverse events or serious side effects related to the use of these products to the FDAs MedWatch Safety Information and Adverse Event Reporting Program.

More here:

FDA urges caution about bodybuilding supplements - CT Post

The Natural Products Association (NPA; Washington, DC) has filed a formal petition asking FDA to shelve the agencys proposed final rule that would enact changes to both the Nutrition Facts and Supplement Facts labels. In its petition, NPA claims that these changes overly burden the food and dietary supplement industries and run counter to the Trump administrations goal of reducing unnecessary regulations.

The association focused heavily on two changes under the proposed final rule. The first is FDAs proposal to list added sugars on the label. NPA says that adding an added-sugars listing is unnecessary because a listing for total sugar is already required on labels today. Given the Trump Administrations stated goal to eradicate overly onerous regulations, NPA says it is now pushing back on what it considers unnecessary and overly burdensome regulations like these.

Daniel Fabricant, PhD, president and CEO, NPA, commented in a press release: We are heartened by the Administrations pledge to weed out bad regulations that only end up costing consumers more money, and this one is exhibit A. This rule was poorly written, rushed, unnecessary, and should be shelved immediately. Labeling is extremely important, but labeling changes posed by FDA must be material and based on scientific evidence or consumer empirical studies and not based on whim or the way the wind happens to be blowing.

The petition notes that data from FDAs own consumer studies do not seem to support the need to add an added-sugars listing to the nutrition label. According to the petition, FDA relied upon consumer studies to support their reasoning for including a new declaration for added sugars but found in these studies that consumers were largely confused about the difference between sugars and added sugarsregardless of whether added-sugar distinctions appeared on the label.

Further, NPA claims that FDAs own eye-tracking studies do not seem to support its decision to include added sugars to the nutrition label, either. FDAs eye-tracking study, which was conducted between January and March of 2015, analyzed the ways that consumers read various nutrition label elements. NPA says that the eye-tracking study sample size was too small and too regionally homogenous to obtain meaningful data. NPA used FDAs raw eye-tracking data in its own independent study on the dwell time of eye fixation (how long consumers looked at individual components of the nutrition label) to determine whether there was difference in how long consumers examined carbohydrates versus added sugars. NPA found that consumers dwell time was lower when consumers were looking at added sugars compared to carbohydrate information, which the association said suggests that the added sugars line does not provide any added benefit.

NPA also questioned FDAs approach to dietary fibers, stating that the agencys decision not to include isolated or synthetic dietary fibers within its new, official fiber definitionwhich was promulgated as part of the proposed label changesare not backed up by scientific or empirical studies. NPA challenged the new fiber definition in its petition, saying that it is selective and inconsistent and does not include isolated or synthetic dietary fibers such as inulin. FDA does not treat dietary fiber consistently as it does most other nutrients, the petition states. FDA has chosen to define dietary fiber in accordance with a showing of its beneficial physiological effect, rather than on the basis of its chemical definition and characteristics. All other nutrients and food components are defined based upon a chemical definition or some quantitative measurement.

Furthermore, the petition notes, NPA does not support FDAs current treatment of dietary fiber in the Food Labeling Final Rule, which requires industry to demonstrate at least one beneficial physiological effect in humans.

Finally, NPA criticizes FDAs failure to submit an economic impact analysis of the economic impact of this rule to the food and supplement industries when the final rule was announced. As NPAs press release states, FDA failed to submit a cost-benefit analysis to the Office of Management and Budget during promulgation of the rule, a clear violation of longstanding Executive Orders, the Regulatory Flexibility Act and the Unfunded Mandates Reform Act of 1995.

In 2014, the FDA proposed new requirements for Nutrition Facts Labels, originally mandated in 1994 and virtually unchanged in the years since. The most notable new requirements included a new way to list serving sizes, listing of added sugars, inclusion of vitamin D and potassium content, and voluntary inclusion of vitamin A and C content. For 90 days following the proposed changes, the FDA accepted public comments, and in May 2016, the new requirements were finalized and implemented. The requirements necessarily extended beyond food products to the supplements industry, and were to be implemented by July 26, 2018; however, the FDA recently revised its compliance deadline, now July 26, 2019, giving the industry more time to complete compliance documents.

More:

NPA Petitions FDA to Stop Changes to Nutrition Facts Label, Supplement Facts Label - Nutritional Outlook

Maggie O'Neill, HealthSource 2:02 p.m. PT June 20, 2017

Bowel movements can tell a variety of details about the eating habits of a person, including the type of food consumed, the diet that is generally followed and even whether supplements or medications are taken.(Photo: gpointstudio/Getty Images/iStockphoto)

Like religion, politics and taxes, bowel movements fall into that realm of not-to-be-talked-about topics. However, bowel movements can tell a variety of details about the eating habits of a person, including the type of food consumed, the diet that is generally followed and even whether supplements or medications are taken.

"Bowel movements are part of our overall health," said Tiffany Barnett, M.D., a doctor in family medicine with Renown Health Premier Care. "Every person has a unique bowel habit and timing, and what is normal for one person may not be normal for their spouse or neighbor."

While it may be typical for one person to have a bowel movement up to three times a day, another person could have a bowel movement every two to three days, she said. However, a 'typical' bowel movement should be shaped and also be brown in color. It also should have a consistency much like soft serve ice cream, according to Barnett.

Nearly everyone knows the results and unpleasant effects of stools that are not regularly consistent. When stools become too loose, diarrhea occurs, but when stools become too hard constipation is the result, Barnett said. Many causes for constipation exist and not just inadequate fiber intake. Other factors include changes in the diet, dehydration, decreased mobility, pregnancy, travel and narcotics, she said.

It is when stools change from their typical appearance or when they cause discomfort during a bowel movement that it may be time to see a doctor.

"Most people do not think much about [bowel movements] too much and that is how it should be," said Erik DeJonghe, an M.D. at Digestive Health Reno. "A change is always important from previous habits and should be looked at."

Changes in stool can occur for a variety of reasons. One cause is medication, particularly medication that has been prescribed for cholesterol, depression, chronic pain or hypertension, said DeJonghe, who also has a master's degree in public health. Another cause for a change is a viral or bacterial infection. Additionally, a chronic illness like diabetes or even a thyroid malfunction, can lead to changes in stool. Alcohol, chewing gum, caffeine, nicotine and soda also can have effects on stools.

"Certain medications, supplements and food items can cause harmless changes in bowel movement color and consistency," Barnett said.

The color of stools can change day to day, depending on what was consumed. Consider that iron supplements and Pepto-Bismol can turn stools gray or black in color, as can medications and supplements,DeJonghe said.

Stools that are yellow-ish in color can be a reflection of excessive fat in consumed foods. Red-colored stools can be the result of eating beets, cranberries, Jell-O or red juices. Green-colored stools, along with diarrhea, indicate that the bile in the body has not had enough time to do its job, which isto break down food,DeJonghe said. Clay-colored stools signal that the bile in the body is not flowing properly, he said.

One of the best ways to stay regular is to consume 20-35 grams of fiber-rich foods daily, Barnett said. Not sure which foods fall into this category? Beans, fresh fruit, vegetables and whole grains are among the fiber-rich options. And, of course, there are lower-fiber foods that should be avoided, particularly when the aim is to become more regular. Items on this list include cheese, ice cream, meat and processed foods. High sugar foods also should be avoided, she said.

Water is an essential component to good digestion and good bowel movements, too.

"You should also drink at least 64 ounces of water each day, reduce stress, exercise daily, avoid reliance on laxatives and do not ignore the urge to have a bowel movement," Barnett said.

Read or Share this story: http://www.rgj.com/story/life/wellness/2017/06/20/bowel-movements-can-reflect-what-you-eat/414022001/

Read the rest here:

'Normal' bowel movements vary from person to person - Reno Gazette Journal

Press Release

This June marks the 10th anniversary of the issuance of the final rule for dietary supplement Good Manufacturing Practices (GMPs), a critical component of the law (21 C.F.R. Part 111) that ensures identity, purity, quality, strength and composition of dietary supplements. Benefitting the consumer and leveling the playing field for the industry, GMPs grant FDA inspection authority and set control standards by which all companies must adhere, including raw materials quality assurance; record-keeping; standards for cleanliness and safety; qualifications of manufacturing personnel; finished product specifications; and production and process controls.

Good manufacturing practices for dietary supplements marked an important turning point for this industry. This milestone anniversary reminds all companies manufacturing dietary supplements that they have a responsibility to consumers and a legal obligation to follow these regulations, said Duffy MacKay, N.D., senior vice president, scientific and regulatory affairs, Council for Responsible Nutrition (CRN). We commend those companies who are not only following GMPs, but who then go above and beyond to adopt additional self-regulatory standards and best practices. More than 170 million Americans take dietary supplements each year with overall confidence, and this can be attributed in part to the mainstream industrys adherence to the law and dedication to manufacturing products of the highest quality.

In recognition of the anniversary, CRN will be hosting a Twitter chat from 3 4 pm EDT on June 22 to discuss the importance of GMPs and to call for increased compliance within the industry. To join the Twitter chat, follow CRN on Twitter (@CRN_Supplements) and use the hashtag #GMPsTurn10.

Background

Prior to the issuance of supplement-specific GMPs in 2007, dietary supplements were covered under conventional food GMPs. Dietary supplement GMPs established more appropriate standards for this specific product category of food. The new GMPs for dietary supplements expanded regulations, among other things, to include control measures such as identity testing of incoming raw materials as well as identity testing of finished products. For more information on dietary supplement regulations, visit: http://www.crnusa.org/industry-regulation.

Here is the original post:

CRN Reflects on Positive Impacts of GMPs - Natural Products INSIDER