The cGMP is a Hard Pill to Swallow

Has the cGMP (current Good Manufacturing Practices) governing dietary supplements failed American consumers? Many healthexperts and industry watchdogs contend that problems with tainted and hidden ingredients are so widespread that regulations should be toughened to protect public health.

U.S. consumers spend more than $36 billion a year on more than 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, protein powders and other supplement ingredients. 1,2

The cGMP consists of rules, instructions and guidelines for supplements sold in the United States.11 Unlike prescription medications, supplements are classified as foods and do not require pre-marketing approval before they reach store shelves. Most consumers are unaware that the Food and Drug Administration (FDA) does not approve dietary supplements prior to marketing.12 Anything labeled as a dietary supplement is assumed to be safe until proven otherwise. 3

Some industry critics complain that, unlike drugs, the cGMP does not require pre-market efficacy for dietary supplements. If a product has no proof that it works, they argue, what trust is it for the consumer?13

Violators of the cGMP are selling over-the-counter adulterated supplements laced with banned botanical ingredients, hidden pharmaceuticals or pharmaceutical analogues, all of which put the consumer’s health at risk. The drug list includes new stimulants, novel anabolic steroids, unapproved antidepressants, banned weight-loss medications, and untested sildenafil analogues, all of which are illegal or available only by prescription. 3, 19.

FDA has recalled 600 products, says 70% of companies don't follow rules

More than 600 recalls for unapproved drug ingredients have been identified by the government since the cGMP was implemented in 2007. Consumer advocates say these numbers represent only a fraction of the contaminated supplements on the market.9 A FDA official estimated in 2013 that 70% of supplement companies transgress the manufacturing rules.18

Today, dietary supplements cause more than 23,000 emergency room visits annually per the New England Journal of Medicine.3,6,7,8. The industry, aided by powerful lawmakers in Congress, says supplements provide valuable health benefits and that only a few unscrupulous companies market tainted products. Others contend the lack of enforcement of industry regulations too often puts the health of unsuspecting consumers at risk.

There is at least one recommended U.S. company that not only adheres to the Good Manufacturing Practices, but far exceeds its regulation. They confirm the efficacy of their dietary supplements through clinical trials prior to marketing.

Critics: cGMP too weak to protect public safety or deter illegal perpetrators

The cGMP final rule was implemented by the FDA in July 2007 as complementary regulation to the Dietary Supplement Health and Education Act (DSHEA) of 1994. That act defined dietary supplements as foods. The DSHEA law tasked the FDA with the responsibility to create and enforce rules under which dietary supplement makers could manufacture and sell products. But the industry carried on without guidelines until the FDA announced the cGMP thirteen years later.

The regulations created manufacturing rules that affect public safety, but a host of industry critics and health experts complain they lack the teeth necessary to deter illegal compositions from entering the marketplace. These skeptics reference the following substantiation of regulatory leniency of the cGMP:3, 15, 16

  • Supplement manufacturers are not required to rigorously test ingredients in their products for safety and quality before marketing. The rules don’t specific how manufacturers should carry out ingredient quality tests. Supplement makers are permitted to conduct whatever ingredient tests they choose to confirm label claims, but the FDA says some don’t test at all.18

  • The law permits dietary supplements to go directly to market carrying unfounded claims about what the supplement does.
  • Foreign and domestic Ingredient suppliers are exempted from the cGMP regulations. Supplement manufacturers are responsible for the safety of raw ingredients in their product formulas.

  • Manufacturers are not required to perform confirmatory testing for common allergens

  • Manufacturers allowed to use ambiguous label terms such as “extract” or “natural”

  • Manufacturers allowed to market dietary supplements without pre-market studies to prove they will deliver the desired result.

  • Unscrupulous supplement manufacturers can ignore the cGMP, avoid the expense of testing, and market contaminated or adulterated products.

  • The FDA is charged with the task of identifying and removing dangerous supplements and taking their producers to court only after they have caused harm.17

Lenient cGMP accommodates proliferation of 'hazardous' supplements

Cynics predicted in 2007 that loopholes in the supplement manufacturing rules could foster an industry with supplement problems and a market of contaminated products.10 The simple fact, they said, is that too much of the industry’s activities fall under the honor system and, for the most part, nobody is checking.10 The New England Journal of Medicine published two articles whose titles capture the cGMP problem: “American Roulette—Contaminated Dietary Supplements” in 2009; and “Hazards of Hindsight—Monitoring the Safety of Dietary Supplements” in 2014. The author, Pieter A. Cohen, M.D., wrote: “Unfortunately, lenient regulatory oversight of dietary supplements combined with the FDA’s lack of resources, has created a marketplace in which manufacturers can introduce hazardous new products with virtual impunity--millions of Americans will continue to be exposed to unacceptable risks.” 3,8

Recently, unscrupulous manufacturers have made it more difficult for the FDA to detect undeclared ingredients by incorporating pharmaceutical analogues into their products. Analogues are created by modifying the original chemical structure of a compound to evade detection by the FDA, making the products more difficult to regulate, and to reduce the risk of patent-infringement lawsuits. 3, 8

“Certain types of supplements, especially those marketed for weight loss, bodybuilding and sexual enhancement, have a history of problems,” said Josephine Briggs, director of the National Center for Complementary and Integrative Health at the National Institutes of Health.

She continued, “Some supplements marketed as ‘all natural’ have been found to contain pharmaceuticals. Certain “herbal Viagra” products, for example, have been found to contain the active ingredient in actual Viagra,” Briggs added that “other supplements have been found to contain dangerous stimulants” 7

Limited resources cripple FDA's enforcement of the cGMP

The dietary supplement industry is exploding with growth with 68% of Americans as consumers. 4. Industry sales have more than doubled from $17.2 billion in 2000 to $36,000 billion in 2017. They’re projected to nearly double again by topping $60 billion in 2021, according to the Nutritional Business Journal. 1,2,5 How will the FDA’s resources keep up with this expected growth? The short answer---they can’t. Not without increased funding. Stretched thin, the agency struggles to enforce all aspects of the governing regulations.

Investigations of supplement-caused adverse health events occupies most of their efforts. Less attention is paid to pre-market manufacturing and sales practices of supplement manufacturers, creating a near open field for supplement fraud.

Supplement buyer beware: American consumers increasingly on their own

Proposed regulatory budget cuts by the Trump administration affecting the Department of Agriculture (the FDA’s parent) could cause even less oversight of dietary supplements. Unless the laws governing dietary supplements are more tightly enforced, or the law is strengthened, Americans increasingly will be on their own when it comes to the safety and effectiveness of these products.14

The past six commissioners of the FDA expressed regret of the agency’s inabilities to ensure safety and legitimacy of dietary supplements. They had gathered in a historic meeting in Aspen, Colorado on June 25, 2016 to critique the capacity of the agency to ensure the safety of what consumers put into and on their bodies.

Margaret Hamburg, who served as FDA commissioner from 2009 to 2015, acknowledged widespread “concern about where these products are coming from and what’s in them.” She noted the FDA “does have some authority around manufacturing, but limited resources make it difficult for FDA to take advantage of the few authorities that they have.”10

One recommended dietary supplement manufacturer surpasses the cGMP

We found one California-based dietary supplement company that is an industry leader for more than 60 years. They are the #1 natural supplement maker in America. We highly recommend them from personal use of many of their products for more than twenty-five years.

They operate more like a pharmaceutical company than a dietary supplement producer. They far exceed the cGMP’s for safety,

purity and efficacy, as noted below:

1. The GMP does not require thorough testing, but the top-rated company conducts 100,000 quality tests per year to ensure product safety. They screen for over 350 contaminants, pesticides, and impurities on every new botanical ingredient, which by far surpasses cGMP and even U.S. Pharmacopeia standards.20

2. The cGMP does not require efficacy of products, but this manufacturer’s dietary supplements are clinically proven, backed by more than 100 patents and patents-pending and by more than 135 published clinical studies, scientific papers, and presentations, including The Landmark Study and the Telomere Study.21 Of course, their products are 100% guaranteed to work.20, 21

3. The cGMP does not require organic ingredients, but the recommended company is beyond organic—-a philosophy that its quality standards go beyond how and where an ingredient is grown. They look to confirm the purity and potency of ingredients after harvest to guarantee that the final finished product is free of hundreds of chemical contaminants.20

The scope of their scientific approach combined with clinical studies of their products is in stark contrast compared to other manufacturers. Their literature claims to “never sacrifice safety and purity for efficacy, and to always create safe products that do what we say they will do. Every single time.”20 The company’s business practices motto is based on The Golden Rule

Their diversified product line consists of supplements for nutrition, targeted solutions, healthy weight, beauty and green household cleaners. For arthritis sufferers, they feature the Pain Trio.

Even though the cGMP rules are considered easy, many companies fall short of compliance. But one company can be trusted when it comes to product safety, efficacy and your health. The following link leads to their prices and product descriptions. Click here for details.

* CGMP Disclaimer: Health statements on this CGMP page have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease

References

1. https://www.statista.com/statistics/235801/retail-sales-of-vitamins-and-nutritional-supplements-in-the-us/ Accessed 11-5-2017 Annual Sales $36 billion

2. https://www.nutraingredients-usa.com/Article/2015/06/01/NBJ-The-US-supplement-industry-is-37-billion-not-12-billion accessed 11-5-2017 Annual Sales $36.7 billion

3. http://www.nejm.org/doi/full/10.1056/NEJMp1315559 Accessed 11-5-2017 Article Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements,Pieter A. Cohen, M.D., N Engl J Med 2014; 370:1277-1280April 3, 2014DOI: 10.1056/NEJMp1315559

4. http://www.crnusa.org/CRNconsumersurvey/2015/ CRN 2016 (Council for Responsible Nutrition) Consumer Survey

5. https://www.forbes.com/sites/davidlariviere/2013/04/18/nutritional-supplements-flexing-their-muscles-as-growth-industry/ Accessed 11-5-2017 Article David Lariviere, 2013 4-18 Forbes, Nutritional Supplements Flexing Muscles As Growth Industry

6. http://library.cqpress.com/cqresearcher/document.php?id=cqresrre2015103000 Accessed 11-4-2017. Jennifer Weeks, 2015 Oct 30 Vol 25 Issue 38 Dietary Supplements: Is regulation of industry too lax? CQ Researcher; 20,000 ER visits 600 tainted recalls since 2007 FDA

7. https://www.usatoday.com/story/news/2015/10/14/side-effects-dietary-supplements-send-23000-people-year-er/73884400/ Side effects from dietary supplements send 23,000 people a year to ER Liz Szabo, USA TODAY Published Oct. 14, 2015

8 http://www.nejm.org/doi/full/10.1056/NEJMp0904768 NEJM article, Perspective American Roulette — Contaminated Dietary Supplements, Pieter A. Cohen, M.D., N Engl J Med 2009; 361:1523-1525October 15, 2009DOI: 10.1056/NEJMp0904768

9 http://www.nejm.org/doi/full/10.1056/NEJMsa1504267. SPECIAL ARTICLE; Emergency Department Visits for Adverse Events Related to Dietary Supplements; Andrew I. Geller, M.D., et al; N Engl J Med 2015; 373:1531-1540October 15, 2015DOI: 10.1056/NEJMsa1504267

10. https://www.theatlantic.com/health/archive/2016/06/supplements-make-tobacco-look-easy/488798/ Accessed 11-4-2017 The Atlantic article Why Vitamins and Other ‘Dietary Supplements’ Can Contain Anything (Six former FDA commissioners regret inabilities to ensure safety and legitimacy of products. By James Hamblin, June 26, 2016

11. https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194344.htm ACCESSED 11-4-2017, About FDA, Are dietary supplements approved by FDA?

12. https://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm FDA Press Release. Food; Fact Sheet: Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts, June 22, 2007 Accessed 11-10-2017

13. https://www.supplements-and-health.com/cgmp-regulations.html cGMP Regulations; Aimed At Safety, Not Effectiveness, Of Supplements

14. http://www.latimes.com/business/lazarus/la-fi-lazarus-dietary-supplements-regulation-20170321-story.html LA Times March 21, 2017, Lazarus, David article: Bitter Pill to Swallow--Less FDA oversight of supplements seems likely

15. http://www.nutritionaloutlook.com, Article, Crane, M, Article, Michael Crane; Attorneys General Urge FDA to “Overhaul” Regulation of Supplements”, Nutritional Outlook, 2015, June Regulatory

16. https://ag.ny.gov/press-release/ag-schneiderman-and-ag-zoeller-urge-food-and-drug-administration-overhaul-regulation Press Release. Schneiderman and Zoeller: “Attorney Generals Urge FDA to Overhaul Regulation of Dietary Supplement Industry”, June 2, 2015

17. https://www.fda.gov/Food/DietarySupplements/default.htm Food, Dietary Supplements, accessed 11-12-2017

18. https://www.newsday.com/news/health/fda-official-70-of-supplement-companies-violate-agency-rules-1.5920525 Ricks, D, Newsday, NewsHealth, FDA Official: 70% of supplement companies violate agency rules. 2013, Aug 23

19. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1678813 May 27, 2013, The Frequency and Characteristics of Dietary Supplement Recalls in the United States,Ziv Harel, MD, MSc et al; Article Information, JAMA Intern Med. 2013;173(10):929-930. doi:10.1001/jamainternmed.2013.379

20. Shaklee Corporation Live Younger Longer Fall 2017 Product Catalog, Clinical Results, Pg 6

21. Shaklee Corporation Live Younger Longer Fall 2017 Product Catalog, The Landmark and Telomere Studies, Pgs 8-9








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