Don’t buy any more supplements until you read this article.
Why? A supplement you buy without doing your homework may be contaminated or mislabeled.
- The Federal Drug Administration found problems and sent warning notices to 62% of the supplement manufacturing sites in U.S. and abroad that it inspected in its fiscal year ending September 30, 2016.1 The FDA inspected only 583 manufacturers, only a small fraction of the thousands of supplement manufacturers so the chances are slim that a supplement that you are interested in buying will come to the attention of the FDA.
- Four national retailers — GNC, Target, Walgreens and Walmart — received Cease and Desist (stop selling) orders in 2015 from the New York State Attorney General’s office. It tested top-selling store brands of herbal supplements and found that four out of five of the products did not contain any of the herbs on their labels.2 Click Who can you trust? to read more.
- The Federal Drug Administration maintains a list of the relatively few manufacturers that have been sent warning notices of violations of current Good Manufacturing Practice (CGMP). You can check to see if a company has been cited. This doesn’t mean that a product is safe or effective. It is like running a background check to see if an applicant has committed a crime. If it comes up negative, that doesn’t mean the person is qualified and hardworking. Click The FDA’s Role or scroll down to read more.
- Independent laboratories are potential sources for information for consumers of supplements: Consumerlab.com Product Reviews and Quality Certification, Labdoor.com, Supplement Rankings, NSF International dietary supplement certification, and U.S. Pharmacopeia dietary supplement verification program. Natural Products Association has a list of companies that it has certified to comply with GMP standards. Click Independent Laboratories or scroll down to read about each of them.
- MyLong HealthyLife.com (that’s us!) is dedicated to presenting the latest and best information available to help persons of all ages maintain good health throughout their lifetimes. That includes helping them find safe, high quality supplements at reasonable prices. Although we do not yet “cover the waterfront” as completely as the Independent Laboratories, we use their information to carefully select supplements to offer for sale on this website. We have no financial incentive to prefer any products over others.
- Drugs.com is recommended for anyone who is taking prescription medications and who wants to check for potential interactions between one’s prescribed medications and supplements one is interested in taking.You can also check for warnings of possible side effects caused by supplements as well as interactions between supplements. It offers a free app that can be downloaded to smart phones and other portable devices.
Supplements manufacturers may not have any of the above approvals or certifications. Some have their own laboratories or hire outside labs to provide assurance that the product was properly manufactured, that it contains the ingredients listed on the label, and that it does not contain harmful levels of contaminants. However, that does not mean that the product is safe or effective, and it is doubtful that you will be able to obtain the details or summaries of laboratory analyzes such as those provided by Consumerlab.com and Labdoor.com.
During fiscal year ended September 30, 2016, the most common infractions found by the FDA were failures to follow current Good Manufacturing Practice (CGMP), including:
- not establishing product specifications for the identity, purity, strength, and/or composition of the finished dietary supplement
- not establishing or following written procedures for quality control
- not conducting at least one appropriate test or examination to verify the identity of a dietary ingredient
The Federal Drug Administration is not authorized to review dietary supplement products for safety and effectiveness before they are marketed. FDA is responsible for taking action against any adulterated or misbranded dietary supplement product only after it reaches the market.3 Manufacturers and distributors do not need FDA approval to sell their dietary supplements, and FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell.
Consumerlab.com (CL) is an easy and accessible place to find the results of extensive testing for quality, safety and accurate labeling, as well as cost information and opinions on best choices (“Top Picks”). CL selects laboratories that are licensed and accredited by federal and state agencies (for example, FDA, USDA, DEA). CL chooses laboratories based on their expertise for specific types of testing. Product Reviews are CL’s independent tests of multiple brands of products claiming to have the same key ingredient. Product Reviews have the following features:
- Products tested are purchased independently by CL at the retail level, not products submitted by the manufacturer or seller.
- Products are selected for testing by CL to reflect popular brands in the market as well as a selection of smaller brands.
- Any product not passing CL’s quality criteria is re-tested for confirmation in a second independent laboratory using similar methods and instrumentation.
Companies that want CL to certify and Approve a supplement that they produce may request that it be tested by CL through its Quality Certification Program. Those supplements may appear in the Product Reviews, along with those selected by CL.
Companies whose products have been Approved by CL may use the CL seal in their packaging and promotion of the product:
However, the absence of the CL Approved seal on the packaging or in promotions does not necessarily mean the product is not Approved by CL.
Labdoor.com has a search feature that lets you check its rankings for many categories of supplements. Labdoor buys products through major retail stores and online sites, just like the everyday consumer. Labdoor does not accept samples from manufacturers for grading or ranking purposes. Products are selected based on market research of popular supplements plus a tally of votes for specific products whenever Labdoor receives direct suggestions from consumers. Quality scores are reported for each product tested using their label claims and laboratory testing results. Quality scores for products are comprised of individual scores for:
- Label Accuracy
- Product Purity – testing for contaminants including heavy metal assays.
- Nutritional Value – based how their macronutrients meet or exceed Dietary Reference Intakes (DRIs), recommendations established by the Institute of Medicine of the National Academies for daily intake.
- Ingredient Safety – whether a product’s active ingredient levels approach or exceed established Tolerable Upper Intake Levels (ULs).
- Projected Efficacy – based on the quantity of each of its active ingredients and how well the body can absorb and use them, including bioavailability, which indicates the fraction of a nutrient’s dose that reaches the bloodstream.
Labdoor.com also does Value Rankings based on price comparisons. It offers products it tests for sale on its site, and the visitor to its site is sent directly to Amazon.com or other websites for purchases.
NSF International differs from Consumerlab and Labdoor in that it makes no comparisons or recommendations and does not provide price information. NSF certifies compliance with current Good Manufacturing Practice (CGMP) of the companies whose dietary supplements it tests. To maintain GMP certification requires periodic onsite inspections of the physical facility and includes evaluations of:
- Physical plant and grounds
- Equipment and utensils
- Production and process control systems
- Holding and distribution
- Product complaints and returns
- Records, record-keeping and documentation
- Recall procedures
- Determination that a product has the identity, strength, composition, quality and purity that appear on its label.
However, Consumerlab reported in 2013 that two companies that NSF had inspected and certified as CGMP-compliant, were cited for numerous violations of CGMP by the FDA. NSF vowed to improve its inspections to address what NSF said was in response to the FDA “ramping up” (making stricter) its standards for dietary supplement manufacturing.
Supplements that are certified by NSF bear this mark:
NSF has a search feature on its website that allows you to search for approved products. If you enter only the company, you will get a list of all of its approved products. For each product, the category, name, form (capsule, tablet, powder, etc.) and the manufacturer’s recommended daily serving size is given. The manufacturer’s address, phone numbers and the cities in which the products are manufactured are also given. If you enter a category – for example, probiotic or vitamin – you will see a list of all that information for each probiotic or vitamin for each company that offers it.
U.S. Pharmacopeia (USP)
USP authorizes companies whose products it has tested to display the USP Verified Mark to “signal to the public that what’s on their label is what’s in the bottle”. There is no mention on the USP website of testing for contaminants or compliance with current Good Manufacturing Practice (CGMP). However, http://www.quality-supplements.org/ carnies this information:
The USP Verified Mark on the label indicated that the product:
- Contains the ingredients listed on the label, in the declared potency and amount
- Does not contain harmful levels of specified contaminants
- Will break down and release into the body within specified amount of time
- Has been made using safe, sanitary and well-controlled manufacturing practices according to FDA and USP guidelines
There are only three brands of supplements that carry this mark, but check each product to be sure the mark appears on the package:
- Kirkland Signature is Costco’s private label.
- Nature Made, a brand that is carried by many retailers.
- TruNature, which is owned by Costco, but also available by other retailers online.
Click here for a list of retailers carrying USP-certified products.
Natural Products Association provides a list of companies that it has certified as complying with current Good Manufacturing Practice (CGMP) , but no individual product testing reports appear on its website.
Many of us assume that the major retailers make sure that the products they offer for sale are safe and effective. Don’t we rely on these four- Walmart, Target, and with dietary supplements, especially GNC and Walgreens – to make sure that their suppliers provide products that contain the supplements stated on the label and that are free from contaminants? The inspectors obtained several herbal supplements (Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, Valerian Root, and Saw Palmetto) from 13 different locations of the these retailers. 390 tests were performed on 78 bottles of these supplements.4 These are the brands purchased and the stores from which they were purchased:
- Spring Valley (Walmart): Of 6 supplements tested, none of the supplements tested consistently revealed DNA from the labeled herb.
- Herbal Plus (GNC): Of 6 supplements tested, only one consistently tested for its labeled contents.
- Finest Nutrition (Walgreens):Of 6 supplements tested, only one consistently tested for its labeled contents.
- Up & Up (Target): Of 6 supplements tested, three supplements showed nearly consistent presence of the labeled contents and the other three did not reveal any of the labeled herb.
Of course, we hope that this was a wake-up call for the major retailers. It certainly was for us. Our purpose is to make you aware of the need to choose carefully. Click Sources to Help You Choose Safe Supplements You Need to take you back up to that section.