Why the emphasis on safety? Aren’t all supplements tested for safety and monitored by the Food and Drug Administration?

The simple, disappointing answer answer is no.

We take for granted the safety of nutritional supplements we find on the shelf but, in fact, there is no safety net protecting consumers from disease-causing pathogens and toxins found in some supplements.

The U.S. Food and Drug Administration (FDA) regulates nutritional supplements as foods and lacks the authority to require safety testing. This is a known problem. You can read more from the respected Pew Trusts.

The problem is real and it affects all of us.

Adulterated supplements have resulted in many well-documented illnesses and deaths. See, for example, this devastating report from trusted source Consumer Reports.

Supplement quality and safety problems are more widespread than any of us thought.

While there is no required testing of supplements, the FDA does, however, check a small sample of the 100,000 nutritional products from 10,000 companies and, unfortunately, has found many that are adulterated. Click for more information. 

What are the adulterants I should be concerned about?

The most concerning toxic ingredients found in supplements are heavy metals, pesticides and microorganisms such as bacteria, yeast, mold, fungi and parasites.

Let’s look at these separately:

• Microorganisms such as bacteria, yeast, molds, fungi and parasites.
  • Bacteria: These pathogenic organisms can cause infections, in the worst case, life-threatening.
  • Yeast, molds and fungi: These are microbials that also cause infections that, in the worst case, can be life threatening.
  • Parasites: Parasites can result in life threatening disease, some cancers and loss of cognitive ability.
  • Heavy metals lead, arsenic, mercury and cadmium: Heavy metals are associated with some cancers, birth defects, kidney damage, neurotoxicity including cognitive and sensory loss, bone fractures and some skin diseases.

How do contaminated supplements make it past the FDA onto store shelves and websites?

There are several loopholes in the system that allow questionable and dangerous supplements to be offered to the public.

• Inadequate testing.
  • In some cases, testing was never done.
  • In-house testing, where a company tests its own products, is a huge conflict of interest that has been demonstrated to allow questionable products to make it to store shelves. The pressure on an employee to approve an adulterated product can be huge when it could mean a loss of hundreds of thousands of dollars for his/her employer if the product is destroyed as it should be.
  • Failure to follow ISO17025 guidelines, the accepted standard for supplement testing, to ensure that test results are accurate.
• Inadequate testing standards.
  • Testing for too few contaminants has resulted in many pathogens making it to market.
    • Heavy Metals and Pesticides: Heavy metal (lead, mercury, cadmium, and arsenic) and pesticide testing are not required by the FDA. Fortunately, the California Office of Environmental Health Hazard Assessment (OEHHA), aka Proposition 65 has stepped up and created the most stringent testing standards, replacing weaker standards in the industry. California Proposition 65 safety compliance is required for products sold in California. If the product does not meet those standards, it must carry a warning label in California, but no warning is required if the product is sold outside California. Click here to learn more about Proposition 65). Supplement companies are free to follow Proposition 65 requirements, as Safe & Sound does, even if the products are not sold in California.
    • Microbials: Bacteria, fungus, yeast, molds, parasites: Many supplements now test for E. coli, coliform and salmonella, but this falls far short of the list of pathogens that have been found in supplements.

The problem of adulterated supplements is well-known. There are many reliable references documenting the problems including this New York Times review.

You can be confident about the safety, quality and value of Safe & Sound supplements. Here is why.

• Every manufacturing batch of every product is independently tested by an ISO 17025 qualified laboratory.
• Final testing is done on bottled and sealed product, not just the raw materials. A lot can and has happened between raw material procurement and bottling of encapsulated product.
• Testing is done to the most stringent standards:
  • Proposition 65 for heavy metals.
  • Proposition 65 for pesticides
  • VitaQual and Safe & Sound standards for more than 25 microbials (as compared to the 3 commonly tested by others).

The bottom line

Nutritional supplements are more important than ever as the nutritional value of many foods has dropped dramatically, as much as 40% in some cases. Click this ASHS article for more information on the reduction of nutrients in our food.

Supplementation can also improve quality of life, provide disease prevention and treat some health problems, in many cases better than drugs and surgery. The scientific data is irrefutable.

Sadly, that benefit can be overshadowed by cost-cutting that allows adulterants and toxins that have been found in supplements, in some cases raising the risks far above the benefits.

The Safe & Sound brand invests in the purchase of the highest quality raw materials, physician developed formulas and rigorous independent testing so that you can be confident that these products deliver the quality, safety and value that you expect from a premium nutritional supplement.

Our Proposition 65 page