Recent FDA Guidance, currently still a draft, aims to clarify the way that the quantity of live micro-organisms present in food supplements can be declared. At present, the amount of all dietary ingredients present in dietary supplements must be indicated by weight per serving. However in the case of probiotics, this approach is not an adequate method because the weight does not reflect the number of viable microorganisms in the product. The presence of live micro-organisms is preferably indicated using Colony Forming Units (CFUs). For that reason, the FDA has considered the use of quantitative indications different from the declaration by weight for use within the supplement facts label. Currently, the label may bear information on the amount of living cells, but only outside the supplements facts section. To allow otherwise would in essence require a revision of the Supplement Facts Regulations. However, the Guidance clarifies that a discretionary approach is applied - allowing for the additional indication by CFU - when conditions as listed in the Guidance are respected. It is stressed the flexible approach only applies for dietary supplements containing probiotics but not for any other dietary ingredients or other types of foods. The current Guidance concerns a draft version, meaning comments can be forwarded until 6 November 2018.

US FDA - Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials - link

DNA barcode testing of supplements in US by Izabela Tanska

10 months ago, New York State Attorney General’s (hereinafter, “AG”) office commissioned a DNA barcode test of herbal dietary supplements. The AG’s office states that the tested products didn’t contain what was declared on the label. Moreover, the supplements also contained some food ingredients that were not declared on the label.

In a study of 18 devil’s claw supplements, the New York Botanical Garden found that for the 16 supplements for which DNA could be identified, all contained zeyheri, either by itself (81%) or mixed with procumbens (19%).

In September AG announced that that his office issued letter demanding that 13 dietary supplements manufacturers cease and desist from the sale, distribution, or marketing of adulterated or misbranded "devil's claw" supplements. The letters are based on a study from the New York Botanical Garden that used an advanced DNA barcoding technique to conclude that the devil’s claw supplements from these manufacturers contained a cheaper related species (Harpagophytum zeyheri) that is considered less desirable.

It is required by federal regulation to identify plant species using the common name standardized in the trade publication, Herbs of Commerce. Most product labels for the supplements tested by the New York Botanical Garden also explicitly referred to the ingredient by its Scientific name, Harpagophytum procumbens.

The companies were requested to take some actions compensating consumers who purchased the adulterated supplements, and to reform their approach to quality control.  

Source: http://www.ag.ny.gov/press-release/ag-schneiderman-issues-cease-and-desist-letters-13-makers-devil%E2%80%99s-claw-supplements

Food safety is one of the most divisive issues in TTIP by Izabela Tanska

The eleventh round of the Transatlantic Trade and Investment Partnership (TTIP) negotiations will take place in Miami, Florida from October 19 - 23, 2015. The Office of the U.S. Trade Representative will host a stakeholder forum to provide an update on negotiations and solicit input and feedback from interested stakeholders, as well as a press conference on Friday 23 October to discuss outcomes from the negotiations.

European Commission: TTIP will fully uphold food safety standards and the way the EU sets them.

President Obama: one of the major objectives for the US is the elimination of food standards ‘not based on science’


GM crops are strictly regulated in the EU, while a number of EU directives prohibit the importation and sale of meat treated with certain growth hormones and chicken washed with chlorine. The US has disputed these rules at the WTO; the EU has argued that the restrictions are necessary for the protection of human health, while the US has called the bans ‘unscientific’, and part of a protectionist strategy to shut US farms out of EU markets.

The Commission has offered assurances that EU regulations on GM and hormones are not up for negotiation (changes to these would have to separately be approved by Council and the European Parliament), while the negotiating mandate states that any agreement must recognise ‘the right for the Parties to appraise and manage risk in accordance with the level of protection that each side deems appropriate’


Sources:http://ec.europa.eu/trade/policy/in-focus/ttip/documents-and events/index_en.htm#economic-benefits

DMBA in Dietary Supplements by Sebastian MELCHOR

DMBA is labeled as a dietary ingredient in some products marketed as dietary supplements. However, the FDA is not aware of any information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. As a result, for dietary supplements that contain DMBA to be lawfully marketed, one of the following must apply:

  1. the product containing the dietary ingredient must contain only dietary ingredients that have been present in the food supply as an article used in food in a form in which the food has not been chemically altered, or 
  2. there must be a history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended in the product labeling, will reasonably be expected to be safe; and prior to bringing the products to market, the manufacturer or distributor must notify FDA of the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably expected to be safe.

Because neither of these conditions has been met by those marketing products that contain or are labeled as containing DMBA as a dietary ingredient, the FDA considers these dietary supplements to be adulterated.

DMBA is also known as:

  • 1,3-Dimethylbutylamine
  • 2-Amino-4-Methylpentane Citrate
  • 4-Amino-2-Methylpentane Citrate
  • 4-Amino Methylpentane Citrate
  • Amperall
  • AMP
  • AMP Citrate
  • 4-AMP Citrate
  • 4-Methyl-2-Pentanamine

FDA Encourages Comments to Help Update Food Ingredient Safety Assessment (Redbook) by Sebastian MELCHOR

April 13, 2015

The U.S. Food and Drug Administration has begun the process of updating its current guidance on food ingredient safety assessment, commonly referred to as the Redbook, and is requesting input from the public.

The agency is interested in developing a framework that incorporates the assessment of ingredients present in various products regulated by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Examples include food additives, food contact substances, ingredients that are generally regarded as safe (GRAS), new plant varieties, dietary supplements and new dietary ingredients, cosmetic ingredients, as well as unavoidable chemical contaminants other than microbial pathogens. 

The FDA is particularly interested in comments on:

  • Which parts of the Redbook should be updated, and how FDA should prioritize updates.
  • The scope of the revised guidance, and what other guidance documents could be addressed or incorporated by reference.
  • New assays, test methods, and endpoints that could be useful for safety assessment, with justifications for why and how these proposed new methods should be considered.
  • Key studies and considerations for study interpretation for each of the regulatory categories of food and cosmetic ingredients and chemical contaminants overseen by CFSAN.
  • Ways to make the guidance more useful to stakeholders.
  • Ways to make our processes and criteria for safety assessment clearer to stakeholders.

Specific examples, precise wording, or other clear and direct suggestions that address these issues are particularly welcome.

To submit comments electronically to the docket, visit http://www.regulations.gov and enter FDA-2014-N-1497 in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-N-1497 on each page of your written comments.

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

The comment period ends on May 11, 2015.

For more information