Busting the Myth of No Regulation

December 2016

Occasionally, you may read an article or hear a report on television that makes a statement regarding the natural supplement industry in a negative light. The article or report may make mention that supplements are “unregulated”. Usually this type of report is disseminated by either a company or agency that has something to gain if supplements were not allowed to be sold over the counter. These types of reports and statements, I feel, are grossly misleading to you, our customer.

The natural health industry, including the Natural Products Association and the Center for Responsible Nutrition have long been fighting against this type of misinformation, and fighting to correctly inform the public that the industry is regulated by the FDA, and in fact has been since 1994.

In response to demand, then Senators Orrin Hatch and Tom Harkin introduced a bill regarding supplement manufacturing and labeling. This bill was signed into law in 1994 under the U.S. Food and Drug Administration regulation and called the Dietary Supplement Health and Education Act (DSHEA). http://www.fda.gov/Food/DietarySupplements/

The FDA regulates both finished dietary supplement products and dietary ingredients. It regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

• Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
• FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.

· Should safety problems arise after marketing, DSHEA makes "adulterated" any dietary supplement that creates a "significant or unreasonable" risk to consumers, thereby subjecting it to FDA enforcement action. Further, in particularly compelling cases, DSHEA allows the Secretary to ban a dietary supplement if she finds it to be an "imminent hazard."

· Finally, as a preventive measure, DSHEA grants FDA explicit authority to establish good manufacturing practice (GMP) regulations for dietary supplements. Such regulations would be intended to establish a mechanism to help assure purity and consistency in dietary supplement products.

· Regarding labeling, DSHEA seeks to provide consumers with information to help guide personal choice. This includes specially tailored requirements for ingredient labeling and nutrition labeling.

· DSHEA also provides for use of claims to affect the structure or function of the body, claims of general well-being from consumption of a nutrient or dietary ingredient, and claims of benefits related to classical nutrient deficiency diseases. These claims require notification to FDA within 30 days after marketing, must be substantiated, and must be accompanied by the disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."

· Finally, DSHEA contains ground rules for publications used in connection with the sale of dietary supplements.

Furthermore, the FDA Good Manufacturing Practice regulation states: http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm079496.htm

• The rule establishes CGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition.
• The requirements include provisions related to:

· the design and construction of physical plants that facilitate maintenance

· cleaning

· proper manufacturing operations

· quality control procedures

· testing final product or incoming and inprocess materials

· handling consumer complaints

· maintaining records.

· Examples of product quality issues that GMP prevents are:

· dietary supplements that contain ingredients in amounts that are greater than those listed on the label dietary supplements that contain ingredients in amounts that are less than those listed on the label

· wrong ingredient

· other contaminant (e.g., bacteria, pesticide, glass, lead)

· foreign material in a dietary supplement container

· improper packaging

· mislabeled

In addition, there are plans for upcoming regulatory enforcement by the FDA of the New Dietary Ingredients Notification (NDI) which requires registration of all ingredients with proof of safety prior to manufacturing. http://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/ucm109764.htm

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration about these ingredients. (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d).) Generally, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.

So, yes, supplements are in fact regulated through the FDA. Now, with that being said, let me also state that although the FDA regulates the natural health industry it does not do so in the same manner that it regulates the pharmaceutical drug industry.

If supplements were regulated as prescription drugs, then many of the items you find in health food stores would disappear. You, the natural health consumer, would then be limited to very few supplement choices that could only be obtained through physician prescription, and most likely at exorbitantly high prices.

I recently had a gentleman come into the store with a prescription he had been given for a very common enzyme formulation typically available over the counter. He told me this prescription would have cost him almost $500.00 and that was after his insurance paid half. Yes, you are reading this correctly!

In addition to the FDA regulations, supplement manufacturers are subject to the Federal Trade Commission's strictest labeling guidelines which are in place to prevent false claims and uphold truth in advertising laws.

Yes, there have been instances where "fly by night" companies try to sell supplements on the internet that are subpar. These companies are quickly shut down when they attempt to circumvent FDA and FTC regulations.

In conclusion, I hope that this information has been helpful in understanding that the supplement industry does in fact have laws in place that it has to adhere to for the safety and efficacy of all the products you love and trust.

Sincerely, and with passion to help people live healthier, more vibrant lives,

Brenda Valen, B.S., CNC, CNHP

Owner, Gulf Coast Nutrition

Welcome to a Healthy New Year 2018
January 1, 2018

Welcome to a New Year. A common New Year’s resolution and one you may be considering for yourself is to incorporate a healthier lifestyle. We are here to help you keep that resolution. And a great place to begin the new healthier year is with a detox or, as some call it, cleansing.

I am not suggesting a fasting process, as there are much easier ways to help encourage your body’s natural detoxification processes without skipping meals.

Dangerous pollutants, chemicals, pesticides, additives etc.… are everywhere in our modern world, which is why it is more important than ever to support your body’s job of breaking down and excreting these harmful substances.

There are many products on the market formulated for just this purpose. To support the function of the body’s seven channels of elimination—the lungs, liver, lymphatic system, kidneys, skin, blood and bowel (or colon). Together, these vital organs and organ systems work nonstop to purge and eliminate harmful toxins from deep within the cells and tissues. Additionally, an effective total-body formula will help to clear the overall detoxification pathways in the body and jumpstart its natural cleansing ability.

How Do I Choose the Best Cleanse for My Needs?

There are several options when it comes to choosing a cleansing/detox product. Below are some general guidelines to help you choose which one may be right for you.

Gentle yet Effective.

• Choose a detoxification formula offering a gentler cleansing experience for novice cleansers or those who have not cleansed in a few years. Such products generally contain whole herbs, which are milder than deep-cleansing herbal extracts. Typically, first-time cleansing formulas last about two weeks and will include a mild colon cleanse to support healthy elimination.

Powerful Overall Support.

• For those familiar with cleansing, an advanced total-body cleanse is often the next step in the detoxification process. A more powerful formula will typically contain concentrated herbal extracts in addition to whole herbs and minerals for a more potent, deep-acting cleanse and should include both a morning formula and an evening formula to nourish and support the body’s 7 channels of elimination and provide a powerful colon cleanse.
  The morning formula may include herbs such as milk thistle, dandelion root and hawthorn berry to support the liver—the primary detoxification organ—and the evening formula may contain a blend of cape aloe, rhubarb, slippery elm, fennel and other herbs to support healthy bowel function. These cleanses can last two weeks to a month.

More Power, Less Time.

• If your on-the-go lifestyle leaves little time for longer detox, a rapid cleansing formula may be the right choice for you. Generally, a 7-day program designed to jumpstart metabolism and provide swift cleansing action, this type of cleanse is also ideal for those about to begin a weight loss program, as it primes the body for optimum digestive function.
  Fast-acting cleansing products combine powerful detoxification herbs with beneficial vitamins and minerals to detoxify the body and replenish needed nutrient. An added fiber component can assist with toxin elimination and healthy bowel function.

There’s Never Been a Better Time to Cleanse

No matter what type of total-body formula you choose, herbal internal cleansing is an essential part of looking and feeling your best every day. It can be a great start to the new year, and a great start to a new you.

Brenda Valen, BS, CNC, CNHP

Gulf Coast Nutrition

CoQ10 Verses Ubiquinol –Which One Is Right for You?
By Brenda Valen, BS, CNC, CNHP

First let me say - although I help you customize a supplement program specific to you, there are a few nutrients I feel everyone can benefit from. And CoQ10 falls into that category.

CoQ10 or Coenzyme Q10, also known as Ubiquinone (because it is ubiquitous in the body), is a fat soluble substance similar to a vitamin that is found in every cell in the human body. Let me repeat that – found in EVERY cell in the human body.

CoQ10 has been researched extensively because of its powerful effects. CoQ10 is essential for energy production within our cells, acts as one of our most powerful antioxidants, helps reduce the signs of aging, improves blood pressure and arterial health and much more.

Although you naturally make some CoQ10, there are many factors that result in a decline in CoQ10 amounts, including aging past 30, insufficient dietary intake, illness, oxidative stress, genetic factors and medications, most notably statins. Statin medications directly reduces the production of CoQ10 and anyone on this medication should always take a CoQ10 supplement.

The organs requiring the most energy and therefore the most CoQ10 are the liver, the kidneys and most notably the heart. CoQ10 is helpful to heart health in many ways. It helps reduce the oxidation of LDL cholesterol which is crucial to cardiovascular health and supports optimal functioning of the heart muscle.

There are two forms of CoQ10 – ubiquinone (normally labeled as CoQ10) and ubiquinol (labeled as Ubiquinol) or the reduced form. We utilize both forms in the body and when we are young our body can easily convert the ubiquinone form to the ubiquinol and vice versa. As we age past 40 our body cannot make this conversion as easily as well as our absorption of regular CoQ10 declines.

Knowing this, in 2007 researchers in Japan developed the reduced form of CoQ10 and made it available in supplement form under the trademarked name Kaneka. When CoQ10 is ingested in its reduced form as ubiquinol, higher blood CoQ10 levels can be achieved using smaller milligram doses.

In conclusion if you are using CoQ10 for general health and energy production the regular form should serve you well. But if you are over 40, if you have cardiovascular issues, if you are on statin medications, if you have muscular degeneration or have other health issues you could benefit greatly from taking the Ubiquinol form of CoQ10.

In best of health,

Brenda Valen, BS, CNC, CNHP

What is CBD? Is it right for you?
June 1, 2017

What is CBD:

CBD is short for a compound called Cannabidiol. Cannabidiol is one of the many active compounds found in the cannabis plant, a genus of flowering plant in the Cannabaceae family that also includes about 170 other plants, including Hops. Just like all the other plants across this earth, the cannabis plant has numerous active constituents that offer us many health benefits. Walk into any health store and you will find bottle after bottle of active constituents from plants, such as silymarin from milk thistle, curcumin from turmeric and carvacrol from oregano.

Health benefits of CBD:

Unlike other plants across this earth, cannabis and its active constituents, the cannabinoids, including CBD, have a unique biological process within the human body. You see, mammals, including humans of course, have what is called an Endocannabinoid System. This system in the human body is a group of receptors located in the brain and across the central and peripheral nervous systems. It plays a crucial role in many physiological processes that help regulate mood, pain sensation, memory, appetite, motivation, and our everyday experience.

It is an established scientific fact that the active constituents of cannabis, including CBD, bind to these receptors and can modulate these physiological responses in the human body. This effect is why the health benefits of CBD can range greatly from person to person, depending on what area of the body needs “help”. As taken from Projectcbd.org “Extensive preclinical research—much of it sponsored by the U.S. government—indicates that CBD has potent anti-tumoral, antioxidant, anti-spasmodic, anti-psychotic, anti-convulsive, and neuroprotective properties. CBD directly activates serotonin receptors, causing an anti-depressant effect, as well.”

Issues related to cannabis:

You may, of course, recognize the cannabis plant, by two of its common names: Marijuana or Hemp. Yes, they are both the cannabis plant. The basic difference is in how the species is bred.

Marijuana is bred to produce various amounts of another cannabinoid – tetrahydrocannabinoil
or more commonly called THC. THC also has many health benefits but when it binds to the receptors in the brain it creates a psychoactive effect. Hence the “high”, and the history behind using marijuana for this effect.

Hemp, on the other hand, is bred to contain as minute amounts as possible of THC. Hemp has been used for its many other purposes such as a source of fiber, protein and fabric. Hemp is legal in the United States under the 2014 Farm Bill, allowing states to grow Hemp to study the growth, cultivation and marketing of the plant. To be considered Hemp, the cannabis plant must be grown to contain 0.3% THC or less. Even though hemp has low levels of THC, it can still produce high levels of other cannabinoids including CBD and therefore still offer health benefits to the human body. Most the CBD products found in health food stores are made from hemp and not from marijuana, making it legal to sell. For now, that is.

Big Issue:

GW Pharmaceuticals is a British biopharmaceutical company (using plants for medicine) which has been studying the effect cannabis has on the body in relation to multiple sclerosis, cancer and epilepsy. Their studies have shown tremendous results. They have submitted an NDA (New Drug Application) to the FDA. When an NDA is submitted to the FDA, the FDA considers the any product containing the substance put out after the date of the NDA submission to be a drug. In this case, the substance is CBD – Cannabidiol. The Hemp Associations and the manufacturers of CBD products are currently fighting this legality, and trying to show the FDA that hemp products, including the oil which naturally contains CBD, have been on the market well before the NDA submission. I certainly hope they are successful as this would mean that the only way to get a concentrated CBD extract would be by prescription.

For more information on CBD or to purchase a CBD product, please stop by the store, we will be happy to help you.

Yours in Health,

Brenda Valen, BS, CNC, CNHP

Gulf Coast Nutrition