Scroll Top
TAINTED

 

DIETARY SUPPLEMENTS

 

Tainted products place consumers at risk of injury and death

 

497
Tainted Products Marketed as Dietary Supplements

Dietary supplements can help people improve or maintain their overall health. But, they may also come with health risks.

What are Dietary Supplements?

Supplements can come in a variety of forms, including tablets, capsules, softgels, gel caps, liquids, gummies, powders, and bars. Some dietary supplements can help you get adequate amounts of essential nutrients. However, supplements can’t take the place of the variety of foods that are important to a healthy eating routine.

Hence:

▪ Calcium and vitamin D help keep bones strong and reduce bone loss.

▪ Folic acid decreases the risk of certain birth defects.

▪ Omega-3 fatty acids from fish oils might help some people with heart disease.

▪ A combination of vitamins C and E, zinc, copper, lutein, and zeaxanthin (known as an AREDS formula) may slow down further vision loss in people with age-related macular degeneration (AMD).

Common dietary supplements include:

• Vitamins (multivitamins or individual vitamins like vitamin D and biotin).

• Minerals (calcium, magnesium, and iron).

• Botanicals or herbs (echinacea and ginger).

• Botanical compounds (caffeine and curcumin).

• Amino acids (tryptophan and glutamine).

• Live microbials (“probiotics”).

How are Dietary Supplements Labeled?

Dietary supplements are required to have a Supplement Facts label that lists the serving size, the number of servings per container, each dietary ingredient in the product, and the amount of certain ingredients per serving. They are also required to have a statement on the front of the product identifying it as a “dietary supplement” or similar term (for example, “vitamin supplement”).

Federal Regulation of Dietary Supplements

Under the Dietary Supplement Health and Education Act (DSHEA), the U.S. Food and Drug Administration (FDA) does not approve dietary supplements before they are sold to the public.

Dietary supplement companies are responsible for ensuring that their products are safe and accurately labeled. Manufacturers must follow good manufacturing practices (GMPs) to ensure the identity, purity, strength, and composition of their products.

Products that have claims to treat, diagnose, prevent, or cure diseases are generally subject to drug regulations.

In fact, there is a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. Moreover, these products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.”

However, the FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Therefore, consumers should use caution when considering purchasing these types of products.

Finally, the Federal Trade Commission (FTC), which monitors product advertising, also requires information about a supplement product to be truthful and not misleading.

Safety and Risk

Here are a few examples:

▪ Too much vitamin A can cause headaches and liver damage, reduce bone strength, and cause birth defects.

▪ Vitamin K can reduce the ability of the blood thinner warfarin to prevent blood from clotting.

▪ Excess iron causes nausea and vomiting and may damage the liver and other organs.

▪ St. John’s wort can speed the breakdown of many medicines and reduce their effectiveness (including some antidepressants, birth control pills, heart medications, anti-HIV medications, and transplant drugs).

▪ Antioxidant supplements, such as vitamins C and E, might reduce the effectiveness of some types of cancer chemotherapy.

▪ Bad reaction or side effect, also known as an adverse event, can range from less serious to life-threatening and can include rash, fatigue, severe and persistent vomiting or diarrhea, difficulty urinating, severe joint and muscle pain, chest pain, or stroke.

What are Tainted Supplements or Foods?

There are hundreds of products marketed as dietary supplements or conventional foods, that contain hidden drugs and chemicals.

FDA lab analyses have found a wide variety of potentially dangerous ingredients that include:

• Approved prescription drug ingredients and their analogues.

• Drugs banned by FDA for safety reasons.

• Controlled substances such as anabolic steroids and stimulant diet drugs.

• New active drug ingredients that are untested and unstudied.

Be an Informed Consumer

Tainted products place consumers at risk of injury and death, especially those consumers with underlying health conditions. These products can also interact in life threatening ways with other medications a consumer may be taking.

Know what’s in your products, first. Products with the following characteristics warrant further investigation.

1. Product Categories:

• Sexual Enhancement • Weight Loss • Bodybuilding • Diabetes.

2. Labeling claims like:

• “Alternative to [approved drug product]” or “legal alternative to
[anabolic steroid]”.

• Sexual enhancement products claiming immediate effects.

• Directions and warnings that resemble FDA approved drug products.

• “May cause positive result in performance enhancing drug test”.

3. Labels primarily in a foreign language.

4. Beware of mass solicitations (particularly emails) from suppliers
and wholesalers offering products in the above categories.

The following list only includes a small fraction of the potentially hazardous products with hidden ingredients marketed to consumers on the internet and in retail establishments.

Hidden Ingredient: Sildenafil

Products

  • S.W.A.G (Sexual Enhancement)
  • Anaconda Strong Formula (Sexual Enhancement)
  • The Silver Bullet (Sexual Enhancement)
  • Nectar Del Amor (Sexual Enhancement)
  • Peru Maca (Sexual Enhancement)
  • Big Penis (Sexual Enhancement)
  • Germany Black Gorilla (Sexual Enhancement)
  • Boss Lion 9000 (Sexual Enhancement)
  • Herb Viagra (Sexual Enhancement)
  • Vigour 800 mg (Sexual Enhancement)
  • PremierZen Black 7000 (Sexual Enhancement)
  • Plant Vigra (Sexual Enhancement)
  • De Guo Heijin Gang (Sexual Enhancement)
  • Black Panther (Sexual Enhancement)
  • Viagra 007 (Sexual Enhancement)
  • Black Storm (Sexual Enhancement)

Hidden Ingredient: Sibutramine

Products

  • Li Da Dai Dai Hua Slimming Capsule (Weight Loss)
  • Slim Forte Slimming Capsule (Weight Loss)
  • Black Gold X Advanced (Weight Loss)
  • 3rd Degree (Weight Loss)
  • Lanugar (Weight Loss)
  • Love in S (Weight Loss)
  • Reduktis Max (Weight Loss)
  • JaDera PLUS (Weight Loss)
  • Livtone (Weight Loss)
  • Adelgasin Plus (Weight Loss)
  • Fruta Bio (Weight Loss)
  • Imperla Elita Vitaccino (Weight Loss)
  • Absolute Nine Slim (Weight Loss)
  • Vy & Tea (Weight Loss)
  • Lishou Slimming Coffee (Weight Loss)
  • 365 Skinny High Intensity (Weight Loss)
  • Body Shape Weight Loss System (Weight Loss)
  • Genesis Ultra Slim Gold (Weight Loss)

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Jianbu Huqian Wan, Ginseng She Lian Wan, Asihuri Plus Forte, products promoted for joint and nerve pain. These products were identified by FDA during an examination of international mail shipments.

FDA laboratory analysis confirmed that they contain dexamethasone, a corticosteroid, chlorpheniramine, and furosemide.

SILDENAFIL

FDA laboratory analysis confirmed that some of these dietary supplements contain sildenafil, the active ingredient in the FDA approved prescription drug Viagra, used to treat erectile dysfunction (ED).

This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Hidden Ingredient

Sildenafil

Product Category

Sexual Enhancement

FDA Enforcement

Firms that sell dietary supplement products play an integral role in preventing tainted supplements from harming consumers, and have a legal responsibility to ensure that the products they sell are not tainted.

Anyone who sells or distributes these illegal products may be subject to:

• Criminal liability – misdemeanors and felonies.

• Seizure of your products.

• Injunction of the responsible party or company.

• Disgorgement of profits and restitution.

However, FDA enforcement actions and consumer advisories for tainted products, only cover a small fraction of the tainted products on the U.S. market.

1630

FDA encourages consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program.

QUESTIONS?
FDA is becoming more active in pursuing criminal convictions for sellers of tainted supplements.

    Related Posts

    Leave a comment

    You must be logged in to post a comment.